BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS ISE MODULE (DOUBLE)

    MDR report key: 4131384 · Received October 1, 2014

    Report

    Report Number
    1823260-2014-07477
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. AN INSTRUMENT MALFUNCTION WAS EXCLUDED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS FOR SEVERAL PATIENT SAMPLES THAT WERE DISCOVERED WHEN A NURSE QUESTIONED WHY THE RESULTS WERE SO LOW. DATA WAS ONLY PROVIDED FOR TWO PATIENT SAMPLES. PATIENT SAMPLE 1 INITIAL RESULT WAS 117 MMOL/L AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER WAS 130 MMOL/L. PATIENT SAMPLE 2 INITIAL RESULT WAS 124.4 MMOL/L AND THE REPEAT RESULT FROM THE COBAS 6000 ANALYZER WAS 137 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EVENT. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED THE ISE TUBING AND SYSTEM FOR ANY POSSIBLE PROBLEMS. HE EXPLAINED TO THE CUSTOMER THAT THERE MIGHT HAVE BEEN A CLOT THAT CLEARED ITSELF SINCE BOTH ISE SYSTEMS WERE HAVING THE SAME ISSUE. HE CONFIRMED BOTH ISE SYSTEMS WERE WORKING FINE WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610614 COBAS 8000 COBAS ISE MODULE (DOUBLE) CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1