BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21534487 · Received March 6, 2025

    Report

    Report Number
    9610824-2025-00006
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 6, 2025
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE REACTION IN THE ANTI-B WELL FOR ONE PATIENT SAMPLE OF BLOOD TYPE A RHD POSITIVE. TESTING WAS CONDUCTED ON THE CUSTOMERS IH-1000 INSTRUMENT. THE CUSTOMER DID NOT PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE AFFECTED LOT. FIRST, ALL CARDS FROM THE RETENTION SAMPLE WERE VISUALLY CHECKED REGARDING THE SEALING FOIL, THE PRESENCE OF SUPERNATANT AND THE GEL HOMOGENEITY AND SHOWED NO ABNORMALTY. FOR THE SEROLOGICAL TESTING, 5 DONORS (BLOOD GROUP A) WITH NEGATIVE SPECIFICITY IN THE ANTI-B CAVITY, AS WELL AS ONE DONOR (BLOOD GROUP B) WITH POSITIVE SPECIFICITY IN THE ANTI-B WERE TESTED ON THE IH-1000. ADDITIONALLY, TWO SAMPLES OF THE IH_BASIC QC SET THAT THE CUSTOMER HAD USED DURING HIS TESTS WERE ALSO USED FOR THIS TEST. ALL RESULTS WERE CORRECT. NO FALSE POSITIVE REACTIONS IN THE ANTI-B CAVITY OCCURRED, ALL SIX DONOR BLOODS REACTED CORRECTLY. NO MANUFACTURING-RELATED QUALITY ISSUE WITH THE CARDS WERE NOTICED. TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE ANALYZED AND NO INSTRUMENT-RELATED ISSUES WERE DETECTED. UPON COMPREHENSIVE TRACEFILE ANALYSIS, WE OBSERVED THAT WELL NO 2 (ANTI-B) WAS DISPENSED AFTER WELL NO. 3 (ANTI-D). WE STRONGLY ASSUME THAT THE FALSE POSITIVE REACTION IN THE ANTI-B WELL OCCURRED DUE TO INTER-WELL CARRY-OVER; SPECIFICALLY, REAGENT DROP CONTAMINATION WITH ANTI-D (PATIENT A+) LED TO A FALSE POSITIVE RESULT IN THE ANTI-B WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593494 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 9443010 07611969964529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IH-1000, SN (B)(6).| IH-BASIC QC, LOT: 9978980072.