BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1461777 · Received June 19, 2009

    Report

    Report Number
    1056600-2009-00126
    Event Type
    Malfunction
    Date Received
    June 19, 2009
    Date of Event
    April 1, 2009
    Report Date
    June 18, 2009
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUBMIT SAMPLES TO OCD, THEREFORE, ADDITIONAL INVESTIGATION COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. SERVICE WAS NOT DISPATCHED SINCE THE CUSTOMER DID NOT REPORT THE TWO FAILURES AT THE TIME OF INCIDENT. CUSTOMER DID STATE THAT ACCEPTABLE RESULTS HAVE BEEN OBTAINED ON THE INSTRUMENT AFTER THESE TWO INSTANCES. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER OR THE GEL CARD LOT #S SINCE THE LAST INCIDENT. REFER TO MEDWATCH MFR #S 1056600-2009-00127 - MTS ANTI-IGG CARD LOT# 013009001-11 (COMPLAINT # 1033896) AND MFR #S 1056600-2009-00128-MTS BUFFERED GEL CARD LOT # 081508004-02 (COMPLAINT # 1033907). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO INSTANCES IN WHICH NEGATIVE/COMPATIBLE CROSSMATCH RESULTS WERE OBTAINED IN (B)(6)AND (B)(6) 2009 DURING PROVUE VALIDATION TESTING. ADDITIONAL CROSSMATCH TESTING PERFORMED IN TUBE METHOD SHOWED EXPECTED POSITIVE/INCOMPATIBLE RESULTS AT IMMEDIATE SPIN. CUSTOMER PERFORMED TESTING IN MANUAL GEL TEST AND OBTAINED IDENTICAL RESULTS AS THE PROVUE INSTRUMENT FOR THE APRIL INCIDENT. TESTING FOR IMMEDIATE SPIN CROSSMATCH WAS PERFORMED USING MTS BUFFERED GEL CARD LOT # 081508004-02; AHG CROSSMATCH TESTING WAS PERFORMED USING MTS ANTI-IGG CARD LOT # 013009001-11. THE CUSTOMER PERFORMED ADDITIONAL TESTING IN (B)(6) 2009 ON THE PROVUE USING VARIOUS BLOOD GROUPS AND OBTAINED ACCEPTABLE RESULTS. THE SAME LOTS OF GEL CARDS WERE USED FOR ALL TESTING. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1