BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1557451 · Received December 1, 2009

    Report

    Report Number
    1823260-2009-08133
    Event Type
    Malfunction
    Date Received
    December 1, 2009
    Date of Event
    November 7, 2009
    Report Date
    December 1, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER PERFORMED A LOT TO LOT COMPARISON FOR CKMB AFTER NOTING A SHIFT IN THE QC RESULTS WHEN SWITCHING FROM REAGENT TO LOT NUMBER 153686 TO REAGENT LOT NUMBER 155150. THE PT SERUM SAMPLES HAD BEEN PREVIOUSLY TESTED AND THE ORIGINAL RESULTS FOR THE PT SAMPLES HAD BEEN REPORTED. THESE RESULTS WERE NOT PROVIDED. THE RESULTS OBTAINED WHEN TESTED FOR THE COMPARISON WERE NOT REPORTED. ALL RESULTS ARE IN NG PER ML. SAMPLE 1 RESULT WITH LOT NUMBER 153686 WAS 6.58, RESULTS WITH LOT NUMBER 155150 WERE 4.98 AND 5.77. SAMPLE 2 RESULT WITH LOT NUMBER 153686 WAS 3.17, RESULTS WITH LOT NUMBER 155150 WERE 2.14 AND 2.35. SAMPLE 3 RESULT WITH LOT NUMBER 153686 WAS 3.77, RESULTS WITH LOT NUMBER 155150 WERE 2.32 AND 2.70. THE USER REFUSED A SERVICE VISIT AS THEY FELT THERE WAS NO ISSUE WITH THE ANALYZER PERFORMANCE.

    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