BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1193364 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07391
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS RESULTS FOR APPROXIMATELY 18 MONTHS FOR SEVERAL ASSAYS. ONE PATIENT EXAMPLE FOR ALKALINE PHOSPHATASE PROVIDED. INITIAL RESULT 141 U/L, REPEAT VALUES FROM PRIMARY TUBE 388, 243, 174, 258, 172 AND 140 U/L. SAMPLE WAS THEN POURED INTO CUP AND REPEATED GIVING 105, 105, 104, 105, 103 AND 103 U/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE, BUT NOTED HE CHECKED THE PROBES, TUBING AND FITTINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK