BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-LGG CARD

    MDR report key: 1191536 · Received September 26, 2008

    Report

    Report Number
    1056600-2008-00309
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN AND RETURN TESTING PERFORMED AT MTS (OCD) WITH KNOWN DONOR SAMPLES CONTAINING ANTI-KELL WAS SATISFACTORY. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. GEL CARDS PERFORMED AS EXPECTED AT THE OCD SITE AND NO FALSE NEGATIVE REACTIVITY WERE OBSERVED IN ANY OF THE GEL CARDS. BATCH RECORD REVIEW WAS WITHIN RELEASE SPECIFICATIONS. A COMPLAINT REVIEW INDICATED NO OTHER SIMILAR COMPLAINTS HAVE BEEN LOGGED AGAINST THIS LOT. INCIDENT IS ISOLATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING VALIDATION TESTING BETWEEN THE ORTHO PROVUE ANALYZER AND MANUAL GEL TEST USING A KNOWN SAMPLE CONTAINING ANTI-KELL, THE SAMPLE FAILED TO REACT IN THE MTS ANTI-LGG CARD LOT # 041608001-14. THE RESULTS ON BOTH THE ANALYZER AND MANUAL GEL TEST WERE NEGATIVE. REPEAT TESTING USING AN ALTERNATE LOT OF GEL CARDS SHOWED WEAKLY POSITIVE REACTIVITY WITH THE SAMPLE. NO ERRONEOUS RESULTS WERE REPORTED. FALSE NEGATIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS ANTI-LGG CARD ANTIBODY SCREENING REAGENT KSZ MICRO TYPING SYSTEMS, INC. NA 041608001-14

    Patients

    Seq Age Sex Outcome Treatment
    1