BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1191535 · Received September 26, 2008

    Report

    Report Number
    1056600-2008-00310
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 26, 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

    A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED FOR THE REPORTED INCIDENT. ALTHOUGH THE LOGS REVIEWED BY OCD CTS REVEALED THE LIS SENT DOWN HUNDREDS OF ORDERS TO THE PROVUE WHEN THE CUSTOMER REQUESTED IT TO UPLOAD, IT IS UNCLEAR HOW THE ISSUE OCCURRED. THE CUSTOMER WAS ADVISED BY CTS TO CONTACT THEIR LIS REPRESENTATIVE TO RESOLVE THE ISSUE. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. INCIDENT IS ISOLATED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER DOWNLOADED RESULTS FOR SAMPLE BARCODE # ON (B) (6) 2008. THE SAMPLE WAS ACTUALLY RECEIVED AND RUN ON (B) (6) 2008. THE CUSTOMER INDICATED RESULTS OF AN UNPROCESSED SAMPLE WERE SENT TO LIS PRIOR TO TESTING. SAMPLE MISIDENTIFICATION MAY LEAD TO REPORTING OF ERRONEOUS TEST RESULTS.

    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