BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1070031 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05214
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS AN ISSUE WITH DISCREPANT CALCIUM PT RESULTS. THIRTY-FIVE PT EXAMPLES PROVIDED, ALL REPEATED RESULTS PERFORMED ON A DIFFERENT ANALYZER. PT 1, INITIAL RESULT 8.3 MG/DL, REPEAT 9.5 MG/DL. PT 2, INITIAL RESULT 7.0 MG/DL, REPEAT 7.8 MG/DL. PT 3, INITIAL RESULT 8.2 MG/DL, REPEAT 9.2 MG/DL. PT 4, INITIAL RESULT 8.1 MG/DL, REPEAT 9.0 MG/DL. PT 5, INITIAL RESULT 8.6 MG/DL, REPEAT 9.4 MG/DL. PT 6, INITIAL RESULT 8.7 MG/DL, REPEAT 9.5 MG/DL. PT 7, INITIAL RESULT 8.3 MG/DL, REPEAT 9.3 MG/DL. PT 8, INITIAL RESULT 8.5 MG/DL, REPEAT 9.3 MG/DL. PT 9, INITIAL RESULT 8.6 MG/DL, REPEAT 9.5 MG/DL. PT 10, INITIAL RESULT 8.2 MG/DL, REPEAT 9.0 MG/DL. PT 11, INITIAL RESULT 8.2 MG/DL, REPEATED TWICE GAVE 8.4 AND 9.2 MG/DL. PT 12, INITIAL RESULT 8.0 MG/DL, REPEAT 9.2 MG/DL. PT 13, INITIAL RESULT 8.4 MG/DL, REPEAT 9.5 MG/DL. PT 14, INITIAL RESULT 8.7 MG/DL, REPEAT 9.7 MG/DL. PT 15, INITIAL RESULT 8.1 MG/DL, REPEAT 9.1 MG/DL. PT 16, INITIAL RESULT 8.1 MG/DL, REPEAT 9.3 MG/DL. PT 17, INITIAL RESULT 7.5 MG/DL, REPEAT 8.4 MG/DL. PT 18, INITIAL RESULT 8.3 MG/DL, REPEAT 9.2 MG/DL. PT 19, INITIAL RESULT 8.5 MG/DL, REPEAT 9.4 MG/DL. PT 20, INITIAL RESULT 8.2 MG/DL, REPEAT 9.0 MG/DL. PT 21, INITIAL RESULT 8.0 MG/DL, REPEAT 8.9 MG/DL. PT 22, INITIAL RESULT 8.1 MG/DL, REPEAT 8.9 MG/DL. PT 23, INITIAL RESULT 8.7 MG/DL, REPEAT 9.5 MG/DL. PT 24, INITIAL RESULT 8.1 MG/DL, REPEATED TWICE 8.3 AND 9.0 MG/DL. PT 25, INITIAL RESULT 8.4 MG/DL, REPEAT 9.3 MG/DL. PT 26, INITIAL RESULT 8.3 MG/DL, REPEAT 9.1 MG/DL. PT 27, INITIAL RESULT 8.3 MG/DL, REPEAT 9.1 MG/DL. PT 28, INITIAL RESULT 8.6 MG/DL, REPEAT 9.5 MG/DL. PT 29, INITIAL RESULT 7.6 MG/DL, REPEAT 8.7 MG/DL. PT 30, INITIAL RESULT 7.5 MG/DL, REPEAT 8.4 MG/DL. PT 31, INITIAL RESULT 7.6 MG/DL, REPEAT 8.5 MG/DL. PT 32, INITIAL RESULT 8.2 MG/DL, REPEAT 9.1 MG/DL. PT 33, INITIAL RESULT 7.1 MG/DL, REPEAT 7.9 MG/DL. PT 34, INITIAL RESULT 7.4 MG/DL, REPEAT 8.3 MG/DL. PT 35, INITIAL RESULT 8.6 MG/DL, REPEAT 9.4 MG/DL. THE ERRONEOUS RESULTS WERE REPORTED, THE PTS WERE NOT ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED A FAULTY VACUUM SOLENOID VALVES TO BE THE CAUSE AND REPLACED SOLENOID VALVES AND THE RINSE MECHANISM TUBING. HE ALSO REPAIRED A LEAK IN THE VACUUM MANIFOLD TUBING. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK