BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 2931727 · Received January 28, 2013

    Report

    Report Number
    1823260-2013-00467
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 26, 2012
    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

    A ROOT CAUSE COULD NOT BE DETERMINED. THE CALIBRATION AND QUALITY CONTROL DATA WERE WITHIN RANGE PRIOR TO THE SAMPLE BEING RUN. ADDITIONAL INFORMATION WAS NOT PROVIDED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE GLUCOSE HK GEN.3 (GLUC) RESULT FOR ONE PATIENT ON THEIR C702 ANALYZER. THE PATIENT'S INITIAL GLUC RESULT WAS 33.4 MMOL/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS QUESTIONED BY THE CLINICIAN. ON (B)(6) 2012, THE PATIENT HAD A SECOND SAMPLE DRAWN AND THE RESULT WAS 4.9 MMOL/L. THE PATIENT'S INITIAL SAMPLE WAS RETESTED AND THE RESULT WAS 4.9 MMOL/L. THE PATIENT WAS NOT HARMED BY THIS EVENT. THE GLUC REAGENT LOT NUMBER WAS 669012 AND THE EXPIRATION DATE WAS 11/29/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37238 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR