BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1005427 · Received February 29, 2008

    Report

    Report Number
    1823260-2008-02007
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCING GETTING DISCREPANT BICARBONATE (CO2) RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING EXAMPLES WERE PROVIDED: PATIENT 1, INITIAL RESULT GAVE 8 MMOL/L; REPEAT GAVE 26 MMOL/L. PATIENT 2, INITIAL RESULT GAVE 19 MMOL/L; REPEATED ON ANOTHER ANALYZER-SAME METHODOLOGY GAVE 29 MMOL/L. PATIENT 3, INITIAL RESULT GAVE 11 MMOL/L; REPEAT GAVE 20 MMOL/L. IN 2008: PATIENT 4, INITIAL RESULT GAVE 9 MMOL/L; REPEAT GAVE 22 MMOL/L. ON THE NEXT DAY: PATIENT 5, INITIAL RESULT GAVE 20 MMOL/L; REPEAT GAVE 29 MMOL/L. ON THE FOLLOWING DAY: PATIENT 6, (MALE), INITIAL RESULT GAVE 8 MMOL/L; REPEATED TWICE GAVE 8 AND 21 MMOL/L. PATIENT 7, INITIAL RESULT GAVE 7 MMOL/L; REPEAT GAVE 22 MMOL/L. PATIENT 8, INITIAL RESULT 10 MMOL/L, REPEAT 25 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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