BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1202364 · Received October 14, 2008

    Report

    Report Number
    MW5008667
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ORTHO CLINICAL
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SECOND ISSUE WITH BLOOD BANK'S OTHRO PROVUE ERRONEOUSLY REPORTING A NEGATIVE RESULT WHEN THE REACTION WAS POSITIVE. THE FIRST EVENT WAS IDENTIFIED A MONTH PRIOR WITH A 2+ ANTI-E ON GEL BEING REPORTED AS NEGATIVE. WHEN THE RESULT WAS COMPARED TO RECENT PATIENT HISTORY, IT WAS NOT CONSISTENT WITH PREVIOUSLY POSITIVE ANTIBODY SCREEN -ANTI-E-. ORTHO WAS CALLED TO REPAIR THE EQUIPMENT AND STATED THIS WAS PROBABLY A CAMERA SENSITIVITY ISSUE. THE CAMERA WAS REPORTEDLY "TWEEKED". BLOOD BANK PERSONNEL BEGAN READING EACH GEL CARD AND COMPARING THE VISUAL RESULTS OF THE CAMERA/AUTOMATED REPORT. IT WAS A MONTH LATER A POSITIVE GEL CARD WAS CALLED "NEGATIVE" BY THE PROVUE. THIS TIME THE AUTOMATION MISSED AN ANTI-D -1+0. WE CONTINUE TO MANUALLY MONITOR ALL VISUAL RESULTS AND COMPARE TO PROVUE RESULTS. DATES OF USE: 3 YEARS. DIAGNOSIS OR REASON FOR USE: AUTOMATED BLOOD BANK ANALYZER - ABO, RH, AB SCREENS/ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE BLOOD BANK ANALYZER KSZ ORTHO CLINICAL MTS PROVUE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR