BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTOGEN

    MDR report key: 2183182 · Received July 28, 2011

    Report

    Report Number
    2250051-2011-00183
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED, CUSTOMER OBTAINED POSITIVE RESULTS WHEN TEST WAS PERFORMED WITH INCREASED INCUBATION. TO DATE, THERE ARE NO SIMILAR COMPLAINTS AGAINST THIS LOT. (B)(4).

    Description of Event or Problem · 1

    PATIENT SAMPLE WITH A PREVIOUS HISTORY OF ANTI-KELL DID NOT REACT WITH S525 IN MANUAL GEL. TESTING WAS PERFORMED WITH A 15 MINUTE INCUBATION. REACTIVITY OF 1+ WAS OBSERVED WHEN SAMPLE WAS TESTED WITH THE KELL POSITIVE PANEL CELLS. CUSTOMER CONFIRMED THE REACTIVITY OF THE KELL ANTIGEN ON THE SELECTOGEN CELLS. AS PART OF TROUBLESHOOTING, TESTING WAS PERFORMED WITH INCREASED INCUBATION TIME (25 MINUTES). A 1+ REACTION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOGEN REAGENT RED CELLS KSZ ORTHO CLINICAL DIAGNOSTICS S525

    Patients

    Seq Age Sex Outcome Treatment
    1