BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL-I11

    MDR report key: 1983141 · Received January 17, 2011

    Report

    Report Number
    9610824-2011-00003
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 14, 2011
    Manufacturer
    BIO-RAD MED DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT CELL 3 OF BIOTESTCELL I11 REACTED FALSE NEGATIVE WHEN TESTED AGAINST FROZEN ANTI-D SAMPLES. CELL 1 TO 4 OF BIOTESTCELL I11 ARE D POSITIVE. WE ARE STILL WAITING FOR THE ANTI-D SAMPLES AND THE COMPLAINED LOT BIOTESTCELL I11 WHICH WERE REQUESTED FROM THE CUSTOMER. DURING THE FINAL SEROLOGICAL CONTROL OF BIOTESTCELL I8 THE CELLS ARE TESTED WITH TWO DIFFERENT DILUTIONS OF AN ANTI-D. ALL D POSITIVE CELLS OF BIOTESTCELL I11 REACTED CORRECTLY POSITIVE. THEREFORE, THE CORRECT ANTIGENICITY OF THE COMPLAINED BIOTESTCELL I11 WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL-I11 BIOTESTCELL-I11 KSZ BIO-RAD MED DIAGNOSTICS GMBH 7045011

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLIDSCREEN PLATES, LOT 7018020| ANTI-AHG, LOT 7016110-02| MLB2, LOT 7013110