BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA (800) HBA1C

    MDR report key: 1030428 · Received April 17, 2008

    Report

    Report Number
    1823260-2008-03324
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT HBA1C RESULTS. INITIAL RESULT 12.2%, REPEAT RESULT 6.1%. INITIAL RESULT WAS REPORTED, PT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE PROBE TUBING CLIP WAS MISSING CAUSING DAMAGE TO PROBE TUBING. THE TUBING WAS REPLACED. IN ADDITION THE WASH STATIONS WERE CLEANED AND CABLE TENSIONS WERE ADJUSTED. PERFORMANCE TEST WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA (800) HBA1C CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800 DEDICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK