BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1357695 · Received March 16, 2009

    Report

    Report Number
    1823260-2009-02037
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Date of Event
    February 23, 2009
    Report Date
    March 16, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE AGE OF THE ISE PINCH TUBING AND REPLACED THE TUBING. THE USER RAN CALIBRATION AND QC TO VERIFY THE ANALYZER PERFORMANCE.

    Description of Event or Problem · 1

    USER HAD NOTED LOW SODIUM RECOVERY AND HAD RECEIVED COMPLAINTS REGARDING PATIENT RECOVERY. THE USER REPLACED THE SODIUM ELECTRODE AND RETESTED FIVE PATIENT SAMPLES THAT HER CLIENT HAD COMPLAINED ABOUT. RESULTS PROVIDED ARE INITIAL, REPEAT AND SECOND REPEAT AFER ELECTRODE CHANGE. SAMPLE 1 RESULTS WERE 133, 130 AND 142 MMOL PER L. SAMPLE 2 RESULTS WERE 132, 129 AND 139 MMOL PER L. SAMPLE 3 RESULTS WERE 131, 130 AND 140 MMOL PER L. SAMPLE 4 RESULTS WERE 133, 130 AND 141 MOL PER L. SAMPLE 5 RESULTS WERE 131, 131 AND 142 MMOL PER L. NO PATIENT RECEIVED TREATMENT BASED ON THE DISCREPANT LOW RESULTS. NO PATIENTS WERE ADVERSELY AFFECTED.

    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