BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1746788 · Received August 8, 2007

    Report

    Report Number
    1823260-2007-06905
    Event Type
    Malfunction
    Date Received
    August 8, 2007
    Date of Event
    July 22, 2007
    Report Date
    August 8, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED HAVING ISSUES WITH SODIUM RECOVERY FOR PATIENT SAMPLES AND GAVE THE FOLLOWING PATIENT RESULTS AS EXAMPLES (SAMPLE# INITIAL/REPEAT ON ANOTHER ANALYZER MMOL/L): 109/138, 124/137. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP REPAIRED THE INSTRUMENT BY REPLACING THE REFERENCE ELECTRODE.

    Description of Event or Problem · 2

    ACCOUNT REPORTED HAVING ISSUES WITH SODIUM RECOVERY FOR PATIENT SAMPLES AND GAVE THE FOLLOWING PATIENT RESULTS AS EXAMPLES (SAMPLE# INITIAL/REPEAT ON ANOTHER ANALYZER MMOL/L): 109/133. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP REPAIRED THE INSTRUMENT BY REPLACING THE REFERENCE ELECTRODE.

    Description of Event or Problem · 3

    ACCOUNT REPORTED HAVING ISSUES WITH SODIUM RECOVERY FOR PATIENT SAMPLES AND GAVE THE FOLLOWING PATIENT RESULTS AS EXAMPLES (SAMPLE# INITIAL/REPEAT ON ANOTHER ANALYZER MMOL/L): 140/132. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP REPAIRED THE INSTRUMENT BY REPLACING THE REFERENCE ELECTRODE.

    Description of Event or Problem · 4

    ACCOUNT REPORTED HAVING ISSUES WITH SODIUM RECOVERY FOR PATIENT SAMPLES AND GAVE THE FOLLOWING PATIENT RESULTS AS EXAMPLES (SAMPLE# INITIAL/REPEAT ON ANOTHER ANALYZER MMOL/L): 159/134. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP REPAIRED THE INSTRUMENT BY REPLACING THE REFERENCE ELECTRODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NP
    2 23 YR NP
    3 50 YR
    4 25 YR