BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL P3

    MDR report key: 2209624 · Received August 3, 2011

    Report

    Report Number
    9610824-2011-00103
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    PMA / PMN Number
    125207-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED A FALSE (B)(6) REACTION OF BIOTESTCELL-P3. WE RECEIVED NEITHER THE COMPLAINED LOT OF BIOTESTCELL-P3 NOR THE AFFECTED SAMPLE OF CUSTOMER. WHEN WE RECEIVED THE COMPLAINT THE REAGENT RED BLOOD CELLS WERE ALREADY EXPIRED. THEREFORE A TESTING OF RETENTION SAMPLE WAS NOT POSSIBLE. AT FINAL SEROLOGICAL CONTROL BIOTESTCELL-P3 WAS TESTED WITH DIFFERENT CONTROLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DIDN'T OBSERVE ANY FALSE (B)(6) REACTIONS. SUMMARY: THE TESTING QUALITY CONTROL LAB HAD CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF BIOTESTCELL-P3. THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL P3 BIOTESTCELL P3 LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 816017 2121011

    Patients

    Seq Age Sex Outcome Treatment
    1