BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE INDIRECT NA+ FOR GEN.2

    MDR report key: 2171727 · Received July 22, 2011

    Report

    Report Number
    1823260-2011-03901
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    November 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE AN EXACT ROOT CAUSE. INCOMPLETE INFORMATION AND DATA WAS PROVIDED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ON-GOING ISSUE WITH QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) RESULTS FOR APPROXIMATELY 75 PATIENTS WHEN TESTED ON A COBAS 6000 C501 MODULE, SERIAL NUMBER (B)(4). THE PHYSICIANS QUESTIONED THE ISE RESULTS AND THEY WERE REPEATED. THE CUSTOMER PROVIDED ISE RESULTS FOR FOUR PATIENT SAMPLES. SODIUM RESULTS FOR THREE PATIENTS, WHEN TESTED ON THIS ANALYZER, WERE ERRONEOUS AND REPORTED OUTSIDE THE LABORATORY. PATIENT 1, INITIAL SODIUM RESULT WAS 154 MMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT, TESTED ON (B)(6) 2011, WAS 138 MMOL/L. IT WAS GENERATED USING ANOTHER COBAS 6000 C501 MODULE, SERIAL #(B)(4). PATIENT 2, FEMALE, (B)(6), INITIAL SODIUM RESULT WAS 155 MMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 140 MMOL/L. PATIENT 3, FEMALE, (B)(6), INITIAL SODIUM RESULT WAS 150 MMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 139 MMOL/L. THE CUSTOMER BELIEVED THE LOWER RESULTS TO BE THE CORRECT RESULTS AND CORRECTED REPORTS WERE SENT. THE CUSTOMER DOCUMENTED "TO HER KNOWLEDGE NO ACTION WAS TAKEN PRIOR TO RESULTS BEING CORRECTED". NO ADVERSE EVENTS WERE REPORTED. THE FIELD SERVICE REPRESENTATIVE DID NOT DETERMINE A CAUSE. QUALITY CONTROL WAS PERFORMED AND WAS WITHIN RANGE. THE CUSTOMER ALSO RAN A PATIENT CONTROL THAT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE INDIRECT NA+ FOR GEN.2 ELECTRODE, ION SPECIFIC, SODIUM JGS ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR