BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 2934606 · Received January 30, 2013

    Report

    Report Number
    1823260-2013-00530
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 5, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN THE (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) WENT ON SITE. THE FSR FOUND THE SAMPLE PROBE WAS BENT, SO HE REPLACED IT. HE RAN CALIBRATION AND QUALITY CONTROL AND IT WAS ACCEPTABLE. A FLUIDICS CHECK ON THE ANALYZER WAS PERFORMED AND ALL WERE ACCEPTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE GLUCOSE HK GEN. 3 RESULT ON THEIR C702 ANALYZER FOR ONE PATIENT. THE PATIENT'S INITIAL GLUCOSE RESULT WAS 41 MMOL/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE CLINICIAN DID NOT BELIEVE THE RESULT SINCE THE PATIENT WAS ALSO TESTED ON A POCT GLUCOSE METER IN THE AE AND WAS NORMAL. THE CLINICIAN REQUESTED THE SAMPLE BE REPEATED. THE SAMPLE WAS REPEATED IN THE SAME C702 ANALYZER TWICE AND THE RESULTS WERE 4.8 MMOL/L AND 4.9 MMOL/L. THERE WERE NO ADVERSE EVENTS. THE GLUCOSE REAGENT LOT NUMBER WAS 672996 AND THE EXPIRATION DATE WAS 03/29/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40284 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR