The PCR (Possible Causal Relationship) segment carries information about a product that is possibly causally related to an adverse event reported via a Product Experience message. Each PCR identifies one implicated product, captures its lifecycle dates and lot identifiers, and records the reporter's assessment of how the product relates to the observed event.
A single adverse-event report may contain one or many PCR segments — one per implicated product (drug, device, biologic) — grouped under a PEO (Product Experience Observation) segment.
Used in
PCR reports the product implicated in an adverse event, used in PEX (product experience) messages. It appears once per implicated product inside the PEX_OBSERVATION / PEX_CAUSE grouping, after the parent PEO segment.
Field-by-field reference
The table below lists every field defined for PCR in HL7 v2.5.1, in segment order. The Seq column is the field identifier (e.g. PCR-1). The Data Type column links to the corresponding v2 data-type reference. Req marks whether the field is required by the standard. Repeat indicates whether the field may repeat in a single PCR instance. Table # references the HL7 user- or HL7-defined table when one is well-established.
| Seq | Name | Data Type | Length | Req | Repeat | Table # | Description |
|---|---|---|---|---|---|---|---|
| PCR-1 | Implicated Product | ce | — | R | — | — | Product suspected of causing the event |
| PCR-2 | Generic Product | is | — | O | — | [HL70249] | Indicates generic vs branded product |
| PCR-3 | Product Class | ce | — | O | — | — | Therapeutic or device class of the product |
| PCR-4 | Total Duration Of Therapy | cq | — | O | — | — | Total elapsed time on the product |
| PCR-5 | Product Manufacture Date | ts | — | O | — | — | Date the product was manufactured |
| PCR-6 | Product Expiration Date | ts | — | O | — | — | Labeled expiration date of the product |
| PCR-7 | Product Implantation Date | ts | — | O | — | — | Date device was implanted in patient |
| PCR-8 | Product Explantation Date | ts | — | O | — | — | Date device was removed from patient |
| PCR-9 | Single Use Device | is | — | O | — | [HL70244] | Whether device is single-use disposable |
| PCR-10 | Indication For Product Use | ce | — | O | — | — | Diagnosis or reason the product was used |
| PCR-11 | Product Problem | is | — | O | — | [HL70245] | Indicates a product problem occurred |
| PCR-12 | Product Serial/Lot Number | st | — | O | Y | — | Serial or lot identifier of the product |
| PCR-13 | Product Available For Inspection | is | — | O | — | [HL70246] | Whether product is available for inspection |
| PCR-14 | Product Evaluation Performed | ce | — | O | — | — | Type of evaluation performed on product |
| PCR-15 | Product Evaluation Status | ce | — | O | — | [HL70247] | Status of the product evaluation |
| PCR-16 | Product Evaluation Results | ce | — | O | — | — | Results of the product evaluation |
| PCR-17 | Evaluated Product Source | id | — | O | — | [HL70248] | Source of the product evaluated |
| PCR-18 | Date Product Returned To Manufacturer | ts | — | O | — | — | Date product was returned to manufacturer |
| PCR-19 | Device Operator Qualifications | id | — | O | — | [HL70242] | Qualifications of the device operator |
| PCR-20 | Relatedness Assessment | id | — | O | — | [HL70250] | Reporter's assessment of product relatedness |
| PCR-21 | Action Taken In Response To The Event | id | — | O | Y | [HL70251] | Action taken regarding the product |
| PCR-22 | Event Causality Observations | id | — | O | Y | [HL70252] | Observations supporting the causality assessment |
| PCR-23 | Indirect Exposure Mechanism | id | — | O | Y | [HL70253] | Mechanism of indirect exposure to product |
Examples
Minimal PCR
The smallest meaningful PCR names only the implicated product.
PCR|00071-0156-01^Acetaminophen 500 MG Oral Tablet^NDC
Fully-populated PCR
A richer PCR captures lot numbers, dates, an indication, and the reporter's causality assessment.
PCR|10019-0178-44^Lisinopril 10 MG Oral Tablet^NDC|G^Generic^HL70249|ACE-INH^ACE Inhibitor^L|45^d^^d&day&UCUM|20250115|20270114|||N^No^HL70244|I10^Essential hypertension^I10|Y^Product problem reported^HL70245|LOT-7741A~LOT-7741B|Y^Available^HL70246|CHEM^Chemical analysis^L|C^Complete^HL70247|NORMAL^Within specification^L|P^Patient^HL70248|20260520|MD^Physician^HL70242|PR^Probable^HL70250|DC^Drug discontinued^HL70251~DR^Dose reduced^HL70251|RC^Rechallenge positive^HL70252|
Annotated breakdown
PCR
|1 Implicated Product = 10019-0178-44 (Lisinopril 10 MG, NDC)
|2 Generic Product = G (generic, table HL70249)
|3 Product Class = ACE-INH (ACE Inhibitor, local table)
|4 Total Duration Of Therapy= 45 days (CQ: quantity + UCUM)
|5 Product Manufacture Date = 2025-01-15
|6 Product Expiration Date = 2027-01-14
|9 Single Use Device = N (not a single-use device)
|10 Indication For Product = I10 Essential hypertension (ICD-10)
|11 Product Problem = Y (problem reported)
|12 Product Serial/Lot Number= LOT-7741A repeated with LOT-7741B
|13 Available For Inspection = Y
|14 Evaluation Performed = CHEM Chemical analysis
|15 Evaluation Status = C Complete
|16 Evaluation Results = NORMAL Within specification
|17 Evaluated Product Source = P Patient
|18 Date Returned To Mfr = 2026-05-20
|19 Device Operator Quals = MD Physician
|20 Relatedness Assessment = PR Probable
|21 Action Taken = DC Discontinued ~ DR Dose reduced (repeats)
|22 Event Causality Obs. = RC Rechallenge positive
In context: PCR inside a PEX adverse-event report
The PEX message groups one or more product experiences. Each PEX_OBSERVATION carries a PEO (the observed event) followed by one PCR per implicated product.
MSH|^~&|EHR|HOSP-ELM|FDA-MEDWATCH|FDA|20260610142500||PEX^P07^PEX_P07|MSG00041|P|2.5.1
EVN|P07|20260610142500
PID|1||MRN-884217^^^HOSP-ELM^MR||DOE^JANE^A||19720314|F
NK1|1|DOE^JOHN^B|SPO^Spouse^HL70063
PV1|1|O|CLINIC-3^^^HOSP-ELM||||A123^SMITH^ANNA^^^^MD
PEO|R^Reaction^HL70287|HEAD^Headache^L|20260605103000|||S^Serious^HL70238
PCR|10019-0178-44^Lisinopril 10 MG Oral Tablet^NDC|G^Generic^HL70249|ACE-INH^ACE Inhibitor^L|45^d^^d&day&UCUM|20250115|20270114|||N^No^HL70244|I10^Essential hypertension^I10|N^No^HL70245|LOT-7741A|||||||||PR^Probable^HL70250|DC^Drug discontinued^HL70251|RC^Rechallenge positive^HL70252|
In context: multiple implicated products
When more than one product is suspected, repeat the PCR segment under the same PEO.
PEO|R^Reaction^HL70287|RASH^Rash^L|20260607080000|||M^Moderate^HL70238
PCR|00071-0156-01^Acetaminophen 500 MG^NDC|G^Generic^HL70249|ANALG^Analgesic^L|3^d^^d&day&UCUM|||||N^No^HL70244|R51^Headache^I10|N^No^HL70245|LOT-AC2210|||||||||PO^Possible^HL70250|DC^Drug discontinued^HL70251||
PCR|00093-0058-01^Amoxicillin 500 MG^NDC|G^Generic^HL70249|ABX^Antibiotic^L|7^d^^d&day&UCUM|||||N^No^HL70244|J02.9^Pharyngitis^I10|N^No^HL70245|LOT-AM4498|||||||||PR^Probable^HL70250|DC^Drug discontinued^HL70251|DR^Dechallenge positive^HL70252|
Notes and gotchas
- PCR-1 is the only field marked required by the standard. Receivers should still accept sparse PCR segments when downstream evaluation has not yet occurred.
- PCR-12 (Product Serial/Lot Number) repeats — useful when more than one lot is implicated in a single event.
- PCR-21, PCR-22, PCR-23 all repeat, allowing multiple actions, multiple causality observations, and multiple indirect-exposure mechanisms to be reported in one segment instance.
- Use HL7 tables HL70249–HL70253 for the coded fields where they exist; many sites also extend with local tables for product class and evaluation type.
FHIR mapping
No segment-level ConceptMap is published in the v2-to-FHIR IG for PCR. Conceptually, PCR maps to AdverseEvent.suspectEntity: PCR-1 populates suspectEntity.instance, PCR-20 maps to suspectEntity.causality.assessment, and PCR-22 maps to suspectEntity.causality.method. Lifecycle dates (PCR-5 through PCR-8) and lot numbers (PCR-12) are typically carried on the referenced Device or Medication resource.
Official sources
- HAPI v2.5.1 PCR javadoc — accessed 2026-06-10
- HAPI HL7v2 v2.5.1 API index — accessed 2026-06-10
- HL7 v2.5.1 product brief — accessed 2026-06-10
