BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SELECTOGEN FOR GEL

    MDR report key: 2945841 · Received February 6, 2013

    Report

    Report Number
    2250051-2013-00018
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING, BATCH RECORD REVIEW, AND COMPLAINT BY LOT REVIEW. ALL RESULTS WERE SATISFACTORY. (B)(4).

    Description of Event or Problem · 1

    A PATIENT SAMPLE WITH NO PRIOR HISTORY REACTED NEGATIVE WITH VS603 CELL II DURING AN ANTIBODY SCREEN. TESTING WAS PERFORMED IN MANUAL GEL. DURING TUBE CROSSMATCHING, ALL UNITS WERE ALL INCOMPATIBLE AT AHG PHASE. THE CUSTOMER THEN PERFORMED ADDITIONAL TESTING USING PANEL CELLS AND ANTI-M WAS IDENTIFIED. REACTIVITY WAS OBSERVED WITH THE HOMOZYGOUS AND HETEROZYGOUS PANEL CELLS. CUSTOMER PERFORMED TESTING WITH AN INCREASED INCUBATION TIME OF 30 MINUTES AND STILL NO REACTIVITY WAS OBSERVED. CUSTOMER PHENOTYPED THE DONOR RED CELL WITH ANTI-M; REACTIVITY OF 2+ WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50757 0.8% SELECTOGEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VS603

    Patients

    Seq Age Sex Outcome Treatment
    1