BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1193367 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07394
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 14, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER SOFTWARE UPDATE, USER EXPERIENCED DISCREPANT RESULTS FOR THREE PATIENTS FOR MULTIPLE ASSAYS. PATIENT 1, INITIAL GLUCOSE RESULT 24 MMOL/L, REPEAT 9.60 MMOL/L. THE DOCTOR QUESTIONED THE INITIAL RESULTS. THE PATIENT WAS NOT ADVERSELY AFFECTED DUE TO ERRONEOUS RESULTS. PATIENT 2, 2008, INITIAL AST RESULT -4, REPEAT 16, UNITS OF MEASURE NOT PROVIDED. PATIENT 3, 2008, INITIAL CALCIUM 82.2, RERUN 1.95, UNITES OF MEASURE NOT PROVIDED. ERRONEOUS RESULTS WERE NOT REPORTED FOR PATIENTS 2 AND 3. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK