BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG

    MDR report key: 3176373 · Received June 19, 2013

    Report

    Report Number
    9610824-2013-00060
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 THAT THEY DID NOT DETECT AN INCOMPATIBLE CROSSMATCH ON AN NYS-DOH PROFICIENCY SAMPLE. THE CUSTOMER HAS NEITHER RETURNED THE PROFICIENCY SAMPLE NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. THE CUSTOMER DID ALSO NOT PROVIDE ANY INFORMATIONS ON THE DATE OF EVENT AND THE USED LOTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF THE ANTI-HUMAN GLOBULIN ANTI-IGG LOT THAT HAD BEEN DELIVERED TO THIS CUSTOMER DURING AN APPROPRIATE TIME FRAME. THIS RETAINED SAMPLE WAS TESTED IN CROSS-MATCHING. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG 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
    278715 ANTI-HUMAN GLOBULIN ANTI-IGG AHG ANTI-IGG KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1