BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1356120 · Received February 26, 2009

    Report

    Report Number
    1056600-2009-00034
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    January 30, 2009
    Report Date
    February 26, 2009
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SATISFACTORY CROSSMATCH RESULTS WERE OBTAINED AT OCD USING RETAINED MTS BUFFERED GEL CARDS WITH KNOWN SAMPLES. THE FIRST SAMPLE TESTED BY THE CUSTOMER REACTED NEGATIVE ON THE PROVUE WITH THE DONOR UNIT. HOWEVER, THE SECOND SAMPLE (DIFFERENT SAMPLE) REACTED POSITIVE ON THE PROVUE WITH THE SAME DONOR UNIT. THE SAME GEL CARD LOTS WERE USED IN BOTH CASES. SAMPLE VARIABILITY MAY HAVE CONTRIBUTED TO THIS INCIDENT. SERVICE WAS NOT REQUIRED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. INCIDENT WAS ISOLATED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER INTERPRETED A WEAKLY POSITIVE CROSSMATCH TEST REACTIONS AS NEGATIVE DURING VALIDATING TESTING. VISUAL INSPECTION OF THE PROCESSED GEL CARDS CONFIRMED THE REACTIONS WERE NEGATIVE. CUSTOMER REPEATED BOTH IMMEDIATE SPIN AND FULL CROSSMATCH TESTING IN MANUAL GEL USING THE SAME SAMPLE, DONOR UNIT, AND LOT OF GEL CARDS. IMMEDIATE SPIN USING MTS BUFFERED GEL CARD WAS NEGATIVE AND THE FULL CROSSMATCH USING MTS ANTI-IGG CARD WAS WEAKLY POSITIVE. IMMEDIATE SPIN TUBE CROSSMATCH WAS 4+. THE B-POS DONOR UNIT WAS RETYPED USING THE MANUAL TUBE METHOD AND CONFIRMED TO BE B-POS. THE SAME DONOR UNIT WAS CROSSMATCHED ON THE PROVUE AGAINST A DIFFERENT SAMPLE (TYPE A-POS). SAME LOT OF GEL CARDS WAS USED. IMMEDIATE SPIN CROSSMATCH WAS 4+ POSITIVE AND THE FULL CROSSMATCH WAS 4+. 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