BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN FOR GEL

    MDR report key: 2913004 · Received January 14, 2013

    Report

    Report Number
    2250051-2013-00012
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAINED TESTING AND A BATCH RECORD REVIEW. RESULTS WERE SATISFACTORY. A COMPLAINT BY LOT REVIEW WAS PERFORMED. THERE WERE NO TRENDS IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO REACTIVITY WITH VSS508 AND A PATIENT SAMPLE WITH A KNOWN ANTI-KELL WHEN TESTED ON THE PROVUE. CUSTOMER THEN PERFORMED TESTING IN MANUAL GEL WITH THE SAMPLE AND ANOTHER SET OF VSS508. REACTIVITY OF 1+ WAS OBSERVED WITH CELL 3. CUSTOMER THEN PERFORMED ANTIBODY IDENTIFICATION STUDIES AND ANTI-KELL WAS IDENTIFIED. ON (B)(6) 2013, CUSTOMER PERFORMED TESTING OF PATIENT SAMPLE ON THE PROVUE USING A DIFFERENT SET OF VSS508. REACTIVITY OF 1+ WAS OBSERVED. AS PART OF TROUBLESHOOTING, CUSTOMER PERFORMED ADDITIONAL ANTIBODY SCREENS WITH THE VARIOUS SETS OF VSS508. REACTIVITY WAS INCONSISTENT UPON REPEAT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20143 0.8% SURGISCREEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VSS508

    Patients

    Seq Age Sex Outcome Treatment
    1