BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1731998 · Received June 22, 2010

    Report

    Report Number
    1823260-2010-03690
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATED SODIUM RESULTS WERE NOT REPLICATING. THEY PROVIDED SODIUM RESULTS FOR SIX PATIENTS, RESULTS FOR THREE OF THE PATIENTS WERE DISCREPANT: PATIENT 1, INITIAL RESULT 128, REPEATED FOUR TIMES GAVE 139, 139, 138, AND 139 MMOL/L. PATIENT 2, TESTED (B) (6) 2010, INITIAL RESULT 131, REPEATED SIX TIMES GAVE 138, 139, 139, 140, 131 AND 140 MMOL/L. PATIENT 3, TESTED (B) (6)2010, INITIAL RESULT 130, REPEATED TWICE GAVE 130 AND 137 MMOL/L. ALL TESTING WAS PERFORMED ON THE SAME ANALYZER. NONE OF THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENTS WERE REPORTED. SODIUM ELECTRODE LOT WAS 21029371001. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ISE TUBING WAS THE CAUSE AND HE REPLACED THE ISE TUBING, WASH TOWER O-RINGS AND SYRINGES. HE RAN PERFORMANCE TESTS, A 10 POINT PRECISION AND QC WHICH WAS ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1