BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1128638 · Received August 20, 2008

    Report

    Report Number
    1823260-2008-06345
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED IMPRECISION WITH QC MATERIALS FOR ALT, AST, CREATININE, GLUCOSE, AND POTASSIUM. NO PATIENT SAMPLES WERE INVOLVED. LEVEL ONE OF QC PRODUCED THE FOLLOWING RESULTS: ALT: 22, 23, 22, 22, 39, 22, 23, 23, 22, 23, 22, 22, 22, 23 I/U. GLUCOSE: 74, 77, 74, 70, 74, 100, 77, 62, 76, 77, 79, 78, 80, 79, 74 MG/DL. POTASSIUM: 2.4, 2.4, 2.4, 2.4, 1.2, 3.3, 2.4, 2.3, 2.4, 2.4, 2.4, 2.4, 2.4, 2.4, 2.4 MMOL/L. LEVEL TWO OF QC PRODUCED THE FOLLOWING RESULTS: ALT: 187, 181, 182, 179, 179, 107, 183, 179, 180, 178, 177, 175, 182, 182, 180 I/U. AST: 247, 239, 241, 239, 237, 128, 248, 247, 243, 243, 239, 237, 244, 245, 246 I/U. CREATININE: 5.7, 5.6, 5.7, 6.2, 5.9, 3.5, 6.0, 5.8, 6.0, 6.0, 5.9, 6.0, 6.0, 5.9, 5.9, 5.9 MG/DL. POTASSIUM: 7.2, 7.2, 7.2, 7.2, 7.2, 5.7, 7.2, 7.2, 7.2, 7.2, 7.2, 7.1, 7.1, 7.1, 7.1 MMOL/L. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS CONTAMINATION IN THE WASH STATION AND DECONTAMINATED THE ANALYZER. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK