BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% SURGISCREEN FOR GEL

    MDR report key: 2781381 · Received October 10, 2012

    Report

    Report Number
    2250051-2012-00243
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) PERFORMED A BATCH RECORD REVIEW. SATISFACTORY RESULTS WERE OBSERVED. SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION BY OCD. THERE ARE NO OTHER COMPLAINTS FOR LACK OF REACTIVITY FOR THIS LOT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH A NEGATIVE ANTIBODY SCREEN WAS USED THE FOLLOWING DAY AS A NEGATIVE CONTROL DURING QC OF A NEW LOT OF SCREENING CELLS. THE CUSTOMER OBTAINED A POSITIVE REACTION WITH THIS NEW LOT OF CELLS AND THE PATIENT SAMPLE. REPEAT TESTING OF (B)(4) WAS NEGATIVE. CUSTOMER PERFORMED ANTIBODY IDENTIFICATION, BUT RESULTS WERE INCONCLUSIVE. SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION BY OCD

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% SURGISCREEN FOR GEL REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS VSS488

    Patients

    Seq Age Sex Outcome Treatment
    1