BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 501 MODULE

    MDR report key: 1012732 · Received March 12, 2008

    Report

    Report Number
    1823260-2008-02367
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 17, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NINE SAMPLES REPRESENTING EIGHT PTS WITH DISCREPANT CALCIUM RESULTS PROVIDED. PT 1, TESTED 2008, INITIAL RESULT 11.6 MG/DL; REPEATED 10.6 MG/DL, CORRECTED REPORT 10.3 MG/DL. PTS 1 THROUGH 5 HAD ERRONEOUS RESULTS REPORTED AND CORRECTED REPORTS GENERATED WITH RESULTS LISTED ABOVE. THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED CAUSE TO BE VALVE V17 AND REPLACED IT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    NINE SAMPLES REPRESENTING EIGHT PTS WITH DISCREPANT CALCIUM RESULTS PROVIDED. PT 2, TESTED 2008, INITIAL RESULT 11.8 MG/DL; REPEATED TWICE 13.1 MG/DL AND 9.4 MG/DL, CORRECTED REPORT 8.9 MG/DL. PTS 1 THROUGH 5 HAD ERRONEOUS RESULTS REPORTED AND CORRECTED REPORTS GENERATED WITH RESULTS LISTED ABOVE. THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED THE CAUSE TO BE VALVE V17 AND REPLACED IT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 3

    NINE SAMPLES REPRESENTING EIGHT PTS WITH DISCREPANT CALCIUM RESULTS PROVIDED. PT 3, TESTED 2008, INITIAL RESULT 11.1 MG/DL; REPEATED TWICE 12.8 AND 9.0 MG/DL, CORRECTED REPORT 8.9 MG/DL. PTS 1 THROUGH 5 HAD ERRONEOUS RESULTS REPORTED AND CORRECTED REPORTS GENERATED WITH RESULTS LISTED ABOVE. THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED THE CAUSE TO BE VALVE V17 AND REPLACED IT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 4

    NINE SAMPLES REPRESENTING EIGHT PTS WITH DISCREPANT CALCIUM RESULTS PROVIDED. PT 4, TESTED 2008, INITIAL RESULT 14.5 MG/DL; REPEATED 15.8 MG/DL. PT 4 RETESTED 2008, DIFFERENT SAMPLE, INITIAL RESULT 12.5 MG/DL, REPEATED 10.3 AND 12.5 MG/DL, CORRECTED REPORT 12.5 MG/DL. PTS 1 THROUGH 5 HAD ERRONEOUS RESULTS REPORTED AND CORRECTED REPORTS GENERATED WITH RESULTS LISTED ABOVE. THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED CAUSE TO BE VALVE V17 AND REPLACED IT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 5

    NINE SAMPLES REPRESENTING EIGHT PTS WITH DISCREPANT CALCIUM RESULTS PROVIDED. PT 5, TESTED 2008, INITIAL RESULT 7.8 MG/DL; REPEATED TWICE 11.0 AND 10.5 MG/DL, CORRECTED REPORT 8.8 MG/DL. PTS 1 THROUGH 5 HAD ERRONEOUS RESULTS REPORTED AND CORRECTED REPORTS GENERATED WITH RESULTS LISTED ABOVE. THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED CAUSE TO BE VALVE V17 AND REPLACED IT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 6

    NINE SAMPLES REPRESENTING EIGHT PTS WITH DISCREPANT CALCIUM RESULTS PROVIDED. PT 6, TESTED 2008, INITIAL RESULT 7.0 MG/DL, REPEATED 9.0 MG/DL. THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED THE CAUSE TO BE VALVE V17 AND REPLACED IT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 7

    NINE SAMPLES REPRESENTING EIGHT PTS WITH DISCREPANT CALCIUM RESULTS PROVIDED. PT 7, TESTED 2008, INITIAL RESULT 8.1 MG/DL; REPEATED TWICE 9.1 AND 8.7 MG/DL (LAST RESULT FROM ANOTHER ANALYZER SAME METHODOLOGY). THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED THE CAUSE TO BE VALVE V17 AND REPLACED IT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 8

    NINE SAMPLES REPRESENTING EIGHT PTS WITH DISCREPANT CALCIUM RESULTS PROVIDED. PT 8, TESTED 2008, INITIAL RESULT 7.7 MG/DL; REPEATED TWICE 8.8 AND 8.6 MG/DL (LAST RESULT FROM ANOTHER ANALYZER SAME METHODOLOGY). THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED CAUSE TO BE VALVE V17 AND REPLACED IT. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR
    2 56 YR
    3 23 YR
    4 70 YR
    5 39 YR
    6 92 YR
    7 67 YR
    8 80 YR