BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL® -I 11 PLUS

    MDR report key: 14539265 · Received May 30, 2022

    Report

    Report Number
    9610824-2022-00029
    Event Type
    Malfunction
    Date Received
    May 30, 2022
    Date of Event
    April 29, 2022
    Report Date
    May 30, 2022
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952441
    PMA / PMN Number
    125207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THAT CELL #10 OF BIOTESTCELL-I11 PLUS (DONOR (B)(6)) SHOWED A FALSE NEGATIVE REACTION WITH ANTI-KPB. ACCORDING TO THE ANTIGEN TABLE DONOR (B)(6) IS KPA-B+. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE BIOTESTCELL-I11 PLUS FOR INVESTIGATIONAL TESTING NOR THE REAGENT THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF BIOTESTCELL-I11 PLUS OF THE SUPPOSEDLY DEFECTIVE LOT WITH THREE DIFFERENT ANTI-KPB. THE USED ANTI-KPB WERE: ANTI-KPB LOT 2038020-00 (FINISHED PRODUCT), ANTI-KPB (HIGH FREQUENT PLASMA) AND ID-ANTIGEN PROFILE II. CELL #10 OF BIOTESTCELL-I11 PLUS SHOWED CLEARLY POSITIVE REACTIONS WITH ALL THREE ANTISERA. BASED ON OUR INVESTIGATION WE COULD NOT CONFIRM THE CUSTOMER'S FINDING. A MISTYPING IN THE ANTIGEN TABLE COULD BE EXCLUDED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661422 REAGENT RED BLOOD CELLS BIOTESTCELL® -I 11 PLUS BIOTESTCELL®-I 11 PLUS; 11X4ML QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 9214011-00 07611969952441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown