BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALTYTICAL D MODULE

    MDR report key: 1052721 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04296
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    APPROX 75 PTS WITH ERRATIC CALCIUM RESULTS. INITIAL RESULTS NOT REPORTED, PTS NOT ADVERSELY AFFECTED. ONLY THE FOLLOWING EXAMPLES WERE PROVIDED: PT 1 INITIAL RESULT 8.3 MG/DL, REPEAT 9.5 MG/DL. PT 2 INITIAL RESULT 7.5 MG/DL, REPEAT RESULT 8.7 MG/DL. PT 3 INITIAL RESULT 8.3 MG/DL, REPEAT 9.4 MG/DL. PT 4 INITIAL RESULT 8.1 MG/DL, REPEAT 9.2 MG/DL. FIELD SERVICE REP FOUND ROOT CAUSE TO BE DIRTY STIRRING PADDLE WHICH WAS CLEANED. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK