BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 2933149 · Received January 29, 2013

    Report

    Report Number
    1823260-2013-00483
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 SAMPLE WAS TESTED FROM THE PRIMARY TUBE THAT WAS PROCESSED ON THE CUSTOMER'S MODULAR PRE ANALYTICS DEVICE. ALL TESTING WAS PERFORMED ON THE SAME ANALYZER. THE PATIENT'S INITIAL GLUC RESULT WAS 0.17 MMOL/L. THE INITIAL RESULT WAS VALIDATED AND REPORTED TO THE CARE UNIT. AS THE INITIAL RESULT WAS WITHIN THE CUSTOMER'S "PANIC VALUE" RANGE, THE SAMPLE WAS REPEATED AND THE RESULT WAS 5.42 MMOL/L. THE REPEAT RESULT WAS REPORTED TO THE CARE UNIT AND THE INITIAL RESULT WAS RECALLED BY THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE GLUC REAGENT LOT NUMBER WAS 66901201 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE RAW DATA AND REACTION KINETICS WERE NOT AVAILABLE FOR INVESTIGATION. IT WAS NOTED THERE WERE SOME ABNORMAL SAMPLE ASPIRATION ALARMS ON THE DAY OF THE EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39109 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER CFR ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR