BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1067571 · Received June 26, 2008

    Report

    Report Number
    1056600-2008-00213
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 26, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED. PRODUCT VIGILANCE REVIEWED A FAXED COPY OF THE PROVUE BATCH-LISTING REPORT SUBMITTED BY THE CUSTOMER, AND VERIFIED THAT THE PROVUE INTERPRETED A MIXED FIELD RESULT AS 2+. ACCORDING TO THE REPORT, THE RUN WAS PERFORMED IN 2008 AND THE CUSTOMER REPORTED THAT THE COMPLAINT TO OCD AT ABOUT 65 DAYS LATER. THE CUSTOMER HAD ALREADY REPEATED THE SURVEY SAMPLE ON THE ANALYZER AND OBTAINED ACCEPTABLE (NRD WITH 'DP', MIXED FIELD) RESULTS PRIOR TO FILING THE COMPLAINT. THEREFORE, SERVICE WAS NOT ORDERED. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THE INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER INTERPRETED A MIXED FIELD / "DP" (DUAL POPULATION) QMBLS SURVEY SAMPLE AS 2+ IN THE ANTI-A MICROTUBE. AN INCORRECTLY INTERPRETED MIXED FIELD REACTION CAN LEAD TO MISCLASSIFICATION OF BLOOD TYPE AND POSSIBLE TRANSFUSION OF INCOMPATIBLE BLOOD.

    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