BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1474038 · Received August 14, 2009

    Report

    Report Number
    1056600-2009-00170
    Event Type
    Malfunction
    Date Received
    August 14, 2009
    Date of Event
    February 25, 2009
    Report Date
    August 14, 2009
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TEN RETROSPECTIVE REVIEW INCIDENTS ARE BEING REPORTED UNDER MEDWATCH MFR #'S 1056600-2009-00169 THROUGH MEDWATCH MFR #'S 1056600-2009-00178. (B) (4).

    Description of Event or Problem · 1

    DURING A SIX MONTH RETROSPECTIVE REVIEW OF A CUSTOMER'S PROVUE RESULTS BY OCD'S SECOND LEVEL SUPPORT (TAC), A TOTAL OF 10 QUESTIONABLE SAMPLES MAY HAVE RESULTED INCORRECTLY. A POSSIBLE MISREAD OF TEN NEGATIVE REACTIONS AS 1+ REACTIONS MAY HAVE OCCURRED IN THE ANTI-A MICROTUBE. SAMPLE (B) (4) WAS TESTED ON (B) (6)2009. BASED UPON THE RETROSPECTIVE REVIEW, THE CUSTOMER WAS NOT SURE WHETHER THE PROVUE REPORTED CORRECT RESULTS. THE CUSTOMER CHANGED THE RESULT TO "NRD" (NO RESULTS DETERMINED AFTER THE REVIEW. ACCORDING TO THE CUSTOMER, THESE RESULTS ARE REPORTED INTERNALLY WITHIN THEIR FACILITY. THE INITIAL COMPLAINT REPORTED ON 7-7-09 WAS REPORTED UNDER MEDWATCH #1056600-2009-00166 (B) (4).

    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