BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1213749 · Received October 22, 2008

    Report

    Report Number
    1823260-2008-07794
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED HIGH RESULTS FOR BICARBONATE, CALCIUM AND MAGNESIUM FOR SEVERAL DAYS. TOTAL NUMBER OF PATIENT SAMPLES INVOLVED WAS NOT GIVEN. FOURTEEN EXAMPLES FROM 2008 WERE PROVIDED. INITIAL RESULTS WERE NOT REPORTED. REPEAT TESTING WAS PERFORMED ON ANOTHER ANALYZER IN 2008. SAMPLE 1 INITIAL RESULTS: BICARBONATE 39 MMOL/L, CALCIUM 10.1 MG/DL; REPEAT RESULTS: BICARBONATE 25 MMOL/L, CALCIUM 8.9 MG/DL. SAMPLE 2 INITIAL RESULTS: BICARBONATE 42 MMOL/L, CALCIUM 9.4 MG/DL; REPEAT RESULTS: BICARBONATE 27 MMOL/L, CALCIUM 8.3 MG/DL. SAMPLE 3 INITIAL RESULTS: BICARBONATE 42 MMOL/L, CALCIUM 10.2 MG/DL; REPEAT RESULTS BICARBONATE 28 MMOL/L, CALCIUM 8.9 MG/DL. SAMPLE 4 INITIAL RESULTS: BICARBONATE 43 MMOL/L, CALCIUM 9.9 MG/DL; REPEAT RESULTS: BICARBONATE 29 MMOL/L, CALCIUM 8.6 MG/DL. SAMPLE 5 INITIAL RESULTS: BICARBONATE 39 MMOL/L, CALCIUM 10.0 MG/DL; REPEAT RESULTS: BICARBONATE 25 MMOL/L, CALCIUM 9.0 MG/DL. SAMPLE 6 INITIAL RESULTS: BICARBONATE 40 MMOL/L, CALCIUM 10.2 MG/DL; REPEAT RESULTS: BICARBONATE 26 MMOL/L, CALCIUM 9.0 MG/DL. SAMPLE 7 INITIAL RESULTS: BICARBONATE 38 MMOL/L, CALCIUM 9.5 MG/DL; REPEAT RESULTS: BICARBONATE 24 MMOL/L, CALCIUM 8.4 MG/DL. SAMPLE 8 INITIAL RESULTS: BICARBONATE 40 MMOL/L, CALCIUM 8.7 MG/DL, MAGNESIUM 3.4 MG/DL; REPEAT RESULTS: BICARBONATE 27 MMOL/L, CALCIUM 7.7 MG/DL, MAGNESIUM 1.7 MG/DL. SAMPLE 9 INITIAL RESULTS: BICARBONATE 39 MMOL/L, CALCIUM 9.7 MG/DL; REPEAT RESULTS: BICARBONATE 25 MMOL/L, CALCIUM 8.5 MG/DL. SAMPLE 10 INITIAL RESULTS: BICARBONATE 41 MMOL/L, CALCIUM 10.3 MG/DL; REPEAT RESULTS: BICARBONATE 25 MMOL/L, CALCIUM 9.0 MG/DL. SAMPLE 11 INITIAL RESULTS: BICARBONATE 35 MMOL/L, CALCIUM 8.7 MG/DL, MAGNESIUM 4.1 MD/DL; REPEAT RESULTS: BICARBONATE 21 MMOL/L, CALCIUM 7.5 MG/DL, MAGNESIUM 2.2 MG/DL. SAMPLE 12 INITIAL RESULTS: BICARBONATE 40 MMOL/L, CALCIUM 9.9 MG/DL; REPEAT RESULTS: BICARBONATE 23 MMOL/L, CALCIUM 8.6 MG/DL. SAMPLE 13 INITIAL RESULTS: BICARBONATE 39 MMOL/L, CALCIUM 9.2 MG/DL; REPEAT RESULTS: BICARBONATE 25 MMOL/L, CALCIUM 8.0 MG/DL. SAMPLE 14 INITIAL RESULTS: BICARBONATE 38 MMOL/L, CALCIUM 10.5 MG/DL; REPEAT RESULTS: BICARBONATE 24 MMOL/L, CALCIUM 9.3 MG/DL. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE POTENTIAL CAUSE WAS THE DI WATER AND DECONTAMINATED AND CLEANED THE ANALYZER WATER TANK. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK