BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1833612 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05413
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 25, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE CUSTOMER WAS UNWILLING TO PROVIDE INFORMATION FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE LOW RESULTS FOR SODIUM WHICH HAS BEEN AN ON-GOING ISSUE ON THE INTEGRA 800 (I800) ANALYZER. THE EVENT INVOLVED TWO PATIENT SAMPLES, WHICH GAVE DISCREPANT RESULTS. THE USER STATED BOTH PATIENTS WERE OUT PATIENTS AND THE SAMPLES WERE COLLECTED AT ANOTHER FACILITY AND BROUGHT TO THE LABORATORY FOR CENTRIFUGATION. PATIENT SAMPLE 1, THE INITIAL SODIUM RESULT GAVE 130 MMOL/L. THE SAMPLE WAS REPEATED TWICE ON THIS I800 ANALYZER GIVING 137 AND 138 MMOL/L. THE SAMPLE WAS ADDITIONALLY REPEATED 10 TIMES ON ANOTHER I800 ANALYZER SERIAL NUMBER (B)(4) AT THE SITE GIVING 137, 135, 136, 136, 136, 136, 135, 136, 136 AND 136 MMOL/L. PATIENT SAMPLE 2, FEMALE, (B)(6) YEARS OF AGE GAVE AN INITIAL RESULT OF 133 MMOL/L. THE SAMPLE WAS REPEATED ON THIS I800 GIVING 139 MMOL/L. THE SAMPLE WAS REPEATED AN ADDITIONAL 10 TIMES ON I800 ANALYZER SERIAL NUMBER (B)(4) GIVING 139, 138, 138, 137, 138, 138, 139, 138, 138 AND 137 MMOL/L. THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND PATIENTS WERE NOT AFFECTED. THE SODIUM ELECTRODE LOT NUMBER WAS 21594532. THE FIELD APPLICATION SPECIALIST FOUND THE USER HAD NOT REPLACED THE SYRINGES ON THE ANALYZER FOR TWO YEARS, ONLY REPLACING THE TIPS ON THE SYRINGES. THE FIELD SERVICE REPRESENTATIVE FOUND A PROBLEM WITH THE SAMPLE TRANSFER ARM. HE REPLACED MULTIPLE COMPONENTS. PERFORMANCE TESTS WERE RUN AND WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR