BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 2061430 · Received April 18, 2011

    Report

    Report Number
    1823260-2011-02095
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 29, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THERE WAS A SOFTWARE ERROR IN THE CANCELLATION PROCESS FOR THE (B)(6) MEASUREMENT. THIS ISSUE HAD ALREADY BEEN RESOLVED BY A MANDATORY SOFTWARE UPDATE. FOLLOW UP WITH THE USER CONFIRMED THEY HAD NOT EXPERIENCED FURTHER ISSUES SINCE THE SOFTWARE ON THEIR ANALYZER WAS UPDATED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE HEMOGLOBIN A1C GENERATION 2 (HGA1C) RESULTS FOR THREE PATIENT SAMPLES OF WHICH THE RESULTS FOR TWO WERE DISCREPANT. PATIENT SAMPLE 1 GAVE NO RESULT AND A DATA FLAG ON THE INITIAL TESTING. THE AUTOMATIC REPEAT RESULT WAS 9.9%. AFTER REPLACING THE REAGENT CASSETTE AND RETESTING, THE RESULT WAS 7.7%. PATIENT SAMPLE 2 GAVE NO RESULT AND A DATA FLAG ON THE INITIAL TESTING. THE AUTOMATIC REPEAT RESULT WAS 9.1%. AFTER REPLACING THE REAGENT CASSETTE AND RETESTING, THE RESULT WAS 7.1%. THE AUTOMATIC REPEAT RESULT WAS REPORTED OUTSIDE THE LABORATORY. IT WAS UNKNOWN IF THE PATIENTS WERE ADVERSELY AFFECTED. THE HGA1C REAGENT LOT NUMBER WAS 64073701. THE FIELD SERVICE REPRESENTATIVE SUSPECTED THERE WAS A PROBLEM WITH THE REAGENT PACK. THE USER STATED ALL HGA1C RESULTS WERE ACCEPTABLE AFTER REPLACING THE REAGENT PACK. THE FIELD SERVICE REPRESENTATIVE CHECKED MULTIPLE AREAS OF THE ANALYZER AND THE USER VERIFIED THE ANALYZER BY RUNNING CALIBRATION AND QUALITY CONTROL WITH ALL RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER LCP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1