BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2024208 · Received February 1, 2011

    Report

    Report Number
    9610824-2011-00026
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    125207-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED FALSE NEGATIVE REACTIONS OF DIFFERENT ANTIBODIES WITH BIOTESTCELL 3. SHE REPORTED THE MISSING OF THE ANTIBODIES DURING A VALIDATION STUDY. THE MISSED ANTIBODIES HAD THE FOLLOWING SPECIFICITIES: 5 X ANTI-E, 2 X ANTI-D, 1 X ANTI-C, 2 X ANTI-K AND 1 X ANTI-JK(A). CUSTOMER SENT US 7 OF THE 11 MISSED ANTIBODIES BUT NOT THE COMPLAINED LOTS OF REAGENT RED BLOOD CELLS BIOTESTCELL 3 (LOT 7051011/DATE OF EVENT (B)(6) 2011, LOT 7051021/DATE OF EVENT (B)(6) 2011, LOT 8103021/DATE OF EVENT (B)(6) 2011 AND LOT 8103021/DATE OF EVENT (B)(6) 2011). THE ANTIBODIES WERE TESTED WITH THE RETENTION SAMPLES OF BIOTESTCELL 3 ON TANGO IN THE QUALITY CONTROL LABORATORY AND REACTED NEGATIVELY. FURTHERMORE THE ANTIBODIES WERE TESTED IN THE GEL METHOD: THEY REACTED NEGATIVELY EXCEPT ONE ANTI-D WHICH REACTED WEAKLY POSITIVE. ADDITION TESTS IN ENZYME AND PEG (POLYETHYLENE-GLYCOL) METHOD WERE PERFORMED TO CONFIRM THE WEAKNESS OF THE ANTIBODIES. IN QUALITY CONTROL LABORATORY, A STUDY WAS PERFORMED TO CONFIRM THE CORRECT FUNCTION OF AFFECTED LOTS OF REAGENTS. THEREFORE, WEAK ANTIBODIES OF DIFFERENT SPECIFICITIES WERE PROCESSED IN TWOFOLD SERIAL DILUTIONS ON TANGO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7051011

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLIDSCREEN II: LOT 7028010| AHG ANTI-IGG SOLIDSCREEN II: LOT 701611003| MLB2: LOT 7951111