BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1191803 · Received October 1, 2008

    Report

    Report Number
    1056600-2008-00311
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 1, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RE-SEATED THE BOTTLE CONNECTORS AND REBOOTED THE INSTRUMENT. QC AND SAMPLES WERE RUN WITH ACCEPTABLE RESULTS. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. (B) (6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DILUTION CUP OVERFLOW AND SPLASHING IN THE PROVUE'S INTERIOR. NO ERRONEOUS RESULTS WERE REPORTED. FLUID LEAK MAY LEAD TO DILUTION OF SAMPLE/REAGENT, CARRY OVER AND/OR CROSS CONTAMINATION AND ERRONEOUS RESULTS WHICH COULD 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