BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B

    MDR report key: 10771406 · Received November 2, 2020

    Report

    Report Number
    9610824-2020-00077
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969964529
    PMA / PMN Number
    125534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE RESPECTIVELY TOO WEAK POSITIVE REACTIONS WITH IH-CELL A1&B (REF #814010100, LOT 8035011) ON IH-CARD ABO/D(DVI-)+ REV. A1, B (REF 813112100, LOT #8013040). THE CUSTOMER TESTED MANUALLY. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING, BUT THREE PATIENT SAMPLES CALLED A, B, C. THE PATIENT SAMPLES WERE TESTED WITH THE IH-CELL A1&B AND IH-CARD LOT THE CUSTOMER HAD USED. THE TESTS WERE PERFORMED MANUALLY ACCORDING TO THE INSTRUCTION FOR USE. SAMPLE A BLOOD GROUP A RH(D) POS.; REVERSE TYPING NOT ANALYZABLE DUE TO HEMOLYSIS. SAMPLE B BLOOD GROUP O RH(D) POS: 3+ WITH IH-CELL A1 AND 1W WITH IH-CELL B. SAMPLE C BLOOD GROUP O RH(D) NEG; 3W WITH IH-CELL A1 AND NEGATIVE WITH IH-CELL B. ADDITIONALLY THE PATIENT SAMPLES A, B AND C WERE TESTED WITH THE CURRENT LOT OF IH-CELL A1&B (LOT #8039011): THE TEST OF SAMPLE A WAS NOT ANALYZABLE DUE TO THE HEMOLYSIS, AND THE SAMPLES B AND C YIELDED NEGATIVE RESULTS WITH IH-CELL B. FURTHERMORE THE PATIENT SAMPLES A, B AND C WERE TESTED WITH BIOTEST CELL B IN THE TUBE TEST (IMMEDIATE SPIN). THE TEST OF SAMPLE A WAS NOT ANALYZABLE DUE TO THE HEMOLYSIS AND THE SAMPLES B AND C YIELDED A 1+ POSITIVE RESULT EACH. ADDITIONALLY, THE RETENTION SAMPLE OF IH-CELL A1&B WAS TESTED WITH 17 DIFFERENT DONOR SAMPLES (10 X BLOOD GROUP O, 2 X BLOOD GROUP A1, 2 X BLOOD GROUP A2, 2 X BLOOD GROUP B AND 1 X BLOOD GROUP A2B). ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE MINIMUM REACTION STRENGTH OF THE POSITIVE REACTIONS WAS 2+ POSITIVE. BASED ON THE RESULTS WITH IH-CELL B OF IH-CELL A1&B, THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - EPP (EXPECTED PRODUCT PERFORMANCE) BECAUSE THE VERY WEAK POSITIVE REACTIONS RESPECTIVELY FALSE NEGATIVE REACTIONS WERE ONLY OBSERVED WITH THE PATIENT SAMPLES. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES, WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE SECTION LIMITATION CONTAINS THE FOLLOWING PASSAGE, "DECREASED ABO ANTIBODY REACTIVITY MAY BE SEEN WITH LOW TITER ISOAGGLUTININ ANTIBODIES MAY BE CAUSED BY DISEASE STATES, THE ELDERLY OR INFANTS RESULTING IN FALSE NEGATIVE REACTIONS." WE DID NOT RECEIVE ANY INFORMATION REGARDING THE AGE, THE MEDICATION, OR THE OCCURRENCE OF ANY DISEASES OF THE AFFECTED PATIENTS, WHICH MIGHT HAVE HAD AN IMPACT TO THE OBSERVED RESULTS OF THE REVERSE TYPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233555 BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8013040 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-CELL A1&B, REF 814010100, LOT 8035011| IH-CENTRIFUGE L SN 2000186