BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S AB0+D

    MDR report key: 2011945 · Received February 8, 2011

    Report

    Report Number
    9610824-2011-00012
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 4, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS WITH ANTI-B AND ONLY WEAK POSITIVE REACTIONS WITH ANTI-AB ON ERYTYPE AB0+D. THE CUSTOMER HAS SENT US THE COMPLAINED LOT OF ERYTYPE AB0+D. THE SAMPLE WAS TESTED MANUALLY WITH DIFFERENT FRESH RED CELLS OF VARIOUS ABO BLOOD GROUPS. ALL POSITIVE REACTIONS WITH THE ANTI-B AND THE ANTI-AB REAGENTS WERE STRONGLY AND CORRECTLY POSITIVE. WE DIDN'T OBSERVE ANY FALSE NEGATIVE RESULTS. THEREFORE, WE CANNOT CONFIRM COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERYTYPE S AB0+D ERYTYPE S AB0+D KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 1023040

    Patients

    Seq Age Sex Outcome Treatment
    1