BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 1172319 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07061
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 30, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED SAMPLE BARCODE READ ERRORS FOR TWO PTS. UPON RERUN OF THE TWO SAMPLES ON A DIFFERENT RACK. USER ALLEGES THE SYSTEM MAY HAVE ASSIGNED THE INCORRECT BARCODE NUMBER TO THE RESULTS THAT WERE GENERATED. BOTH SAMPLES WERE REPEATED GIVING CONSISTENT RESULTS. PT 1 SHOWED THE FOLLOWING DISCREPANT RESULTS FROM THE INITIAL RESULT VS. RESULTS GENERATED FROM THE REANALYSIS. INITIAL GGT GAVE 97, REPEAT 52: INITIAL FERRITIN GAVE 440.0, REPEAT 78.18; INITIAL ALT GAVE 19, REPEAT 30; INITIAL TSH GAVE 1.92, RERUN 3.59. NO UNITS OF MEASURE PROVIDED. ERRONEOUS RESULTS WERE NOT REPORTED AND THE PTS DID NOT RECEIVE MEDICATION BASED ON THE ERRANT RESULTS. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK