BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1133410 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06365
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVING DISCREPANT CREATININE AND CK RESULTS. EXACT NUMBER OF PATIENT SAMPLES IMPACTED NOT PROVIDED. TWO PATIENT EXAMPLES WERE PROVIDED. PATIENT 1, INITIAL CREATININE GAVE <3.9 MG/DL; REPEAT GAVE 0.7 MG/DL. PATIENT 2, INITIAL CK GAVE 9 U/L; SAMPLE REPEATED FOUR TIMES GIVING 61, 65, 11 AND 42 U/L. THE USER INDICATED THE PHYSICIAN DID NOT BELIEVE THE INITIAL RESULTS AND THE USER WAS NOT PROVIDED INFORMATION TO DETERMINE IF MEDICINE WAS ADMINISTERED TO THE PATIENT. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE CONTAMINATION OF SAMPLE PROBE 2 WASH STATION, AND DECONTAMINATED THE SYSTEM, REPLACED SYRINGE SEALS, SAMPLE AND REAGENT PROBES. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK