BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1000775 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01651
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008, WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 1, INITIAL GAVE 33 MMOL/L; REPEAT GAVE 26 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 2

    USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008 WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 2, INITIAL GAVE 33 MMOL/L; REPEAT GAVE 26 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 3

    USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008 WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 3, INITIAL GAVE 34 MMOL/L; REPEAT GAVE 27 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 4

    USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008 WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 4, INITIAL GAVE 33 MMOL/L; REPEAT GAVE 26 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO 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
    2
    3
    4