BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1832006 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05375
    Event Type
    Malfunction
    Date Received
    September 13, 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 EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    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.

    Description of Event or Problem · 1

    USER EXPERIENCED ONGOING ISSUE WITH LOW SODIUM RESULTS AND RECEIVED A QUESTIONABLE LOW RESULT FOR SODIUM ON THE INTEGRA 800 (I800) ANALYZER FOR ONE PATIENT SAMPLE. THE EVENT INVOLVED ONE PATIENT SAMPLE COLLECTED ON (B)(6) 2010 FROM THE PATIENT WHILE IN THE EMERGENCY ROOM. THIS SAMPLE WAS TESTED ON (B)(6) 2010 GIVING DISCREPANT RESULTS. THE INITIAL RESULT FOR SODIUM GAVE 123 MMOL/L. THE REPEAT RESULT WAS 133 MMOL/L. THE LABORATORY PROCEDURE DICTATES A SHORT PRECISION OF 5 REPLICATES BE PERFORMED WHEN A LOW OR HIGH RESULT IS DETECTED. THE USER REPEATED THE SAMPLE 5 TIMES GIVING 134, 134, 133, 134 & 133 MMOL/L. USER SAID THE DISCREPANT RESULTS WERE NOT REPORTED AND THE PATIENT WAS NOT AFFECTED. THE SODIUM ELECTRODE LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND A CLOT IN THE ISE MIXING TOWER. HE REPLACED MULTIPLE COMPONENTS AND PERFORMED ADJUSTMENTS. PERFORMANCE TESTS WERE RUN WHICH WERE WITHIN SPECIFICATION.

    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