BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1831306 · Received September 10, 2010

    Report

    Report Number
    1823260-2010-05373
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 23, 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 RESULTS FOR SODIUM ON THE INTEGRA 800 ANALYZER. ONE PATIENT SAMPLE WAS INVOLVED IN THE EVENT AND WAS DISCREPANT. THE INITIAL RESULT FOR SODIUM GAVE 135 MMOL/L. THE SAMPLE WAS REPEATED TWICE GIVING 129 AND 130 MMOL/L. THE USER SAID ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY, AND NO HARM TO PATIENTS OR PERSONNEL REGARDING THIS EVENT. THE SODIUM ELECTRODE LOT NUMBER WAS 21594532. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO REPRODUCE THE ISSUE. HE CHECKED PIPETTING PRECISION AND ISE ASSEMBLY. PERFORMANCE TESTS WERE RUN WITH ALL VALUES WITHIN RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, RESISTANCE WAS ENCOUNTERED AND THE GUIDE WIRE COATING WAS "COMING OFF". THE 300CM KINETIX PLUS PTCA GUIDE WIRE WAS PLACED IN AN UNKNOWN VESSEL. AN 8MM X 3.00MM QUANTUM APEX BALLOON CATHETER WAS ADVANCED OVER THE WIRE. THE PHYSICIAN NOTED A "TACKY FEEL" WHILE REMOVING THE APEX BALLOON CATHETER FROM THE KINETIX WIRE; HOWEVER, THE BALLOON WAS ABLE TO BE REMOVED FROM THE WIRE. IT WAS FURTHER NOTED THAT THE COATING OF THE GUIDE WIRE MAY HAVE PEELED OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    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