BEUDAMED
    FDA Adverse Event Other Summary report: N

    ID-MTS A/B/D MONOCLONAL BLOOD GROUPING CARD

    MDR report key: 424812 · Received October 23, 2002

    Report

    Report Number
    1056600-2002-00002
    Event Type
    Other
    Date Received
    October 23, 2002
    Date of Event
    April 29, 2002
    Report Date
    October 22, 2002
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES A CORD BLOOD TYPED BY TUBE METHODOLOGY AS A POSITIVE. THIS SAME SAMPLE WAS TESTED BY MTS A/B/D GEL CARD AFTER WASHING THE CELLS 4X. ONE CARD WAS SPUN AND READ USING THE READER AND THE OTHER CARD SPUN AND READ MANUALLY. THE CARD READ BY THE READER TYPED AS A POS, THE CARD READ MANUALLY TYPED AS AB POS. BECAUSE OF DISCREPANCY, THE CUSTOMER WASHED THE CELLS 6X AND REPEATED TESTING BY USING THE READER. THE PATIENT TYPED AS GROUP O. THERE WAS NO REPORT OF HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ID-MTS A/B/D MONOCLONAL BLOOD GROUPING CARD BLOOD GROUPING REAGENT KSZ MICRO TYPING SYSTEMS, INC. NA 020701053-04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other