BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1676700 · Received May 7, 2010

    Report

    Report Number
    1823260-2010-02768
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    April 23, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B) (4)

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE CUSTOMER PERFORMS SODIUM ANALYSIS ON THIS ANALYZER USING AN INDIRECT ISE MODE. THE CUSTOMER WAS COMPARING THESE RESULTS WITH THOSE FROM AN ANALYZER THAT USED A DIRECT ISE MODE. DUE TO THE SOLVENT EXCLUSION EFFECT IT IS NOT POSSIBLE TO COMPARE RESULTS OBTAINED THROUGH INDIRECT ISE MEASUREMENT WITH THOSE OBTAINED THROUGH DIRECT ISE MEASUREMENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE SODIUM RESULTS ON 7 PATIENT SAMPLES, 3 OF WHICH WERE FOUND TO BE DISCREPANT. PATIENT 1: FEMALE, DATE OF BIRTH 11/10/1935 COBAS INTEGRA 400 PLUS SODIUM = 131 MMOL/L ALTERNATE METHOD SODIUM = 141 MMOL/L PATIENT 2: MALE, (B) (6) COBAS INTEGRA 400 PLUS SODIUM = 130 MMOL/L ALTERNATE METHOD SODIUM = 136 MMOL/L PATIENT 3: FEMALE, (B) (6), NOT PREGNANT COBAS INTEGRA 400 PLUS SODIUM = 134 MMOL/L ALTERNATE METHOD SODIUM = 141 MMOL/L SODIUM ISE LOT NUMBER: 21594916 THE CUSTOMER STATED THAT NONE OF THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THEREFORE, NO PATIENTS WERE AFFECTED BY THE RESULTS. THE FIELD SERVICE REPRESENTATIVE REPLACED THE SODIUM ELECTRODE AND PERFORMED ELECTRODE SERVICE AND RECOMMENDED MAINTENANCE. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROLS WERE RUN AS WELL AS A CORRELATION STUDY WITH PATIENT SPECIMENS. THE CUSTOMER WAS SATISFIED WITH THE RESULTS.

    Description of Event or Problem · 1

    DURING AN IMPLANT PROCEDURE, A PHYSICIAN FOUND IMPEDANCE MEASUREMENTS TO BE GREATER THEN 10,000 OHMS USING AN EXTERNAL NERVE STIMULATOR DEVICE. THE PATIENT DID NOT FEEL ANY STIMULATION. THE PHYSICIAN TRIED TO RECONNECT THE LEAD TO THE TEMPORARY EXTENSION SEVERAL TIMES. IN ADDITION, THE PHYSICIAN TRIED TO PERFORM TEMPORARY STIMULATION USING THEIR SCREENING DEVICE (MODEL 3625). REGARDING BOTH TYPES OF ATTEMPTS NOTED, THE PATIENT STILL WAS UNABLE TO FEEL ANY PARESTHESIA. IT WAS INDICATED THAT THE LEADS WERE INITIALLY IMPLANTED WITHOUT DIFFICULTY. AN ALTERNATE NEW LEAD WAS IMPLANTED, AND THE FIRST IMPEDANCE MEASUREMENTS RESULTED IN BEING GREATER THAN 10,000 OHMS ALSO. HOWEVER, AFTER RECONNECTING THE LEAD AGAIN, THE PATIENT STARTED TO FEEL STIMULATION AND ALL IMPEDANCE MEASUREMENT BECAME NORMAL. THE PATIENT WAS NOTED TO HAVE "OK" WITHOUT ANY INJURY. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW-UP, AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR LIPITOR -DAILY| COLACE - DAILY| CENTRUM SILVER| ALTACE - DAILY| SPIRIVA| METAMUCIL - DAILY| TYLENOL - PRN| CITRUCEL DAILY| DILTIAZEM - DAILY| "APIRIN" DAILY| ALLEGRA - ONCE DAILY| ADVAIR - TWICE DAILY| ALBUTEROL - DAILY| SINGULAIR - DAILY| "MILK OF MAG" - PRN| PRILOSEC - DAILY| EFFEXOR - DAILY| DIAZEPAM - PRN