BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-IGG GEL CARD

    MDR report key: 2994217 · Received March 8, 2013

    Report

    Report Number
    1056600-2013-00006
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    January 19, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED TESTING, BATCH RECORD REVIEW, AND A COMPLAINT REVIEW WERE PERFORMED. ALL RESULTS WERE SATISFACTORY. CUSTOMER'S CONCERN WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN ANTIBODY SCREEN WAS PERFORMED WITH A PATIENT SAMPLE WITH NO PREVIOUS HISTORY OF ANTI-D WHEN TESTED IN GEL, AND AGAIN THE RESULTS WERE NEGATIVE IN GEL. SINCE THE CUSTOMER HAD RECENTLY OBTAINED A COMPETITOR'S INSTRUMENT, THE SAMPLE WAS ALSO TESTED ON THAT INSTRUMENT. RESULTS OBTAINED FROM THE INSTRUMENT INDICATED 3+ REACTIVITY WITH THEIR SCREENING CELLS. AS PART OF TROUBLESHOOTING, A SECOND LOT OF GEL WAS ALSO TESTED AND NO REACTIVITY WAS OBSERVED WITH THAT SAMPLE. CUSTOMER LATER IDENTIFIED AN ANTI-D USING COMPETITOR CELLS. ANOTHER SAMPLE FROM THIS PATIENT WAS RECEIVED 10 DAYS LATER AND TESTED IN BOTH GEL AND ON THE INSTRUMENT. REACTIVITY WAS OBSERVED IN BOTH GEL (2+) AND ON THE INSTRUMENT (3+) WITH THIS SAMPLE. THE SAME LOT OF GEL CARDS USED AS PART OF THE ORIGINAL TROUBLESHOOTING WAS USED. SAMPLE WAS TESTED IN TUBE/PEG AND 2+ REACTION NOTED. THE PATIENT'S DAT WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98974 MTS ANTI-IGG GEL CARD ANTIBODY SCREENING REAGENT KSZ MICROTYPING SYSTEMS 073112001-12

    Patients

    Seq Age Sex Outcome Treatment
    1