BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1336240 · Received March 9, 2009

    Report

    Report Number
    1823260-2007-04890
    Event Type
    Malfunction
    Date Received
    March 9, 2009
    Date of Event
    May 22, 2007
    Report Date
    June 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    Z-1060-04
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INITIAL HBA 1C RESULT OF 6.8%. SAME SAMPLE REPEATED TWICE GAVE RESULTS OF 10.0% AND 6.9%. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRSENTATIVE DETERMINED THE CAUSE TO BE EXCESSIVE VIBRATION OF A WORKSTATION ON THE ANALYZER. THE INSTRUMENT WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1