BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1030492 · Received April 17, 2008

    Report

    Report Number
    1056600-2008-00116
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    February 8, 2008
    Report Date
    April 17, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER INDICATED THAT THE CUSTOMER WAS PASSING ALL QC AND THE ANALYZER WAS FUNCTIONING AS EXPECTED. SERVICE WAS NOT PERFORMED. OCD COMPLAINT HANDLING UNIT REVIEWED THE PROVUE RESULTS AND CONFIRMED THAT ALL THE 5 SAMPLES WERE NEGATIVE IN THE MICROTUBES. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THE INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE PERFORMING CROSSMATCH/COMPATIBILITY TESTING, THE ANALYZER INTERPRETED ALL THE RESULTS AS NEGATIVE (COMPATIBLE). THE SUMMARY REPORT INDICATED THAT 2 OF THE SAMPLES WERE INCOMPATIBLE. THE CUSTOMER REPEATED TESTING ON THE ANALYZER AND OBTAINED THE SAME NEGATIVE RESULTS. NO ERRONEOUS RESULTS WERE REPORTED. FALSE NEGATIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1