BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-D BLEND

    MDR report key: 3834370 · Received May 28, 2014

    Report

    Report Number
    9610824-2014-00041
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS WITH SERACLONE ANTI-D BLEND. THE CUSTOMER HAS NEITHER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SERACLONE ANTI-D BLEND SAMPLE WITH DIFFERENT RH(D) POSITIVE RED BLOOD CELLS. ALL POSITIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE POTENCY OF THE RETAINED SAMPLE WAS ALSO TESTED. THE REQUIRED MINIMUM TITER HAS BEEN MET. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-D BLEND FUNCTIONS CORRECTLY. 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
    313285 BLOOD GROUPING REAGENT ANTI-D BLEND SERACLONE ANTI-D BLEND KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2330061-00

    Patients

    Seq Age Sex Outcome Treatment
    1