BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1030437 · Received April 17, 2008

    Report

    Report Number
    1823260-2008-03328
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCED LOW PATIENT RESULTS FOR MULTIPLE ASSAYS, WHEN COMPARED TO REPEAT TESTING ON ANOTHER ANALYZER. THE FOLLOWING PATIENT EXAMPLES WERE PROVIDED. PATIENT 1, INITIAL CALCIUM GAVE 3.1 MG/DL; REPEAT GAVE 9.8 MG/DL. PATIENT 2, INITIAL BUN GAVE 4 MG/DL; REPEAT GAVE 22 MG/DL. INITIAL CALCIUM GAVE 06 MG/DL; REPEAT GAVE 9.3 MG/DL. INITIAL GLUCOSE GAVE 56 MG/DL; REPEAT GAVE 139 MG/DL. INITIAL ALK PHOS GAVE 13 U/L; REPEAT GAVE 48 U/L. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE THE CELLS WERE OVERFLOWING, AND ADJUSTED THE WATER FLOW TO CELLS. PERFORMANCE TESTS WERE PERFORMED.

    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