BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1532861 · Received November 3, 2009

    Report

    Report Number
    1823260-2009-07538
    Event Type
    Malfunction
    Date Received
    November 3, 2009
    Date of Event
    October 10, 2009
    Report Date
    November 3, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER STATED THEY ARE VALIDATING A NEW LOT NUMBER OF CKMB REAGENT AND NOTICED A DROP IN THEIR QC RECOVERY AND PATIENT RESULTS RUN FOR COMPARISON. THE USER PROVIDED RESULTS FOR FIVE SAMPLES TESTED ON THE ORIGINAL REAGENT LOT NUMBERS 153686 AND THEN REPEATED ON THE NEW REAGENT LOT NUMBER 155150. OF THE DATA PROVIDED, THREE RESULTS WERE DISCREPANT. ALL RESULTS ARE IN NG PER ML. SAMPLE 1 ORIGINAL RESULT WAS 4.9 TWICE, REPEAT RESULT WAS 4.0. SAMPLE 2 ORIGINAL RESULTS WERE 3.7 AND 3.4, REPEAT RESULT WAS 2.4. SAMPLE 3 ORIGINAL RESULTS WERE 3.9 AND 3.8, REPEAT RESULT WAS 2.9. NONE OF THE RESULTS RUN ON THE NEW LOT OF REAGENT WERE TURNED OUT. THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK