BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1172210 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07051
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT TOXO IGG RESULTS FOR TWO PATIENT SAMPLES. REPEAT TESTING PERFORMED BY A DIFFERENT METHOD - NO UNITS OF MEASURE PROVIDED FO THIS METHOD. PATIENT 1: IN 2008 INITIAL RESULT GAVE 12.68 IU/ML; REPEAT GAVE 1. A SECOND SAMPLE WAS OBTAINED TWO WEEKS LATER FROM THIS PATIENT WHICH INITIALLY RESULTED AS 52.63 IU/ML; REPEAT BY DIFFERENT METHOD GAVE 3. NO INFORMATION PROVIDED TO DETERMINE IF INITIAL RESULTS WERE REPORTED, OR IF ANY ADVERSE EVENTS OCCURED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 2

    USER EXPERIENCED DISCREPANT TOXO IGG RESULTS FOR TWO PATIENT SAMPLES. REPEAT TESTING PERFORMED BY A DIFFERENT METHOD - NO UNITS OF MEASURE PROVIDED FOR THIS METHOD. PATIENT 2:(FEMALE-MOTHER OF PATIENT 1), IN 2008 INITIAL RESULT GAVE 30.36 IU/ML; REPEAT GAVE 5. A SECOND SAMPLE WAS OBTAINED TWO WEEKS LATER FROM THIS PATIENT WHICH INITIALLY RESULTED AS 52.63 IU/ML; REPEAT BY DIFFERENT METHOD GAVE 3. NO INFORMATION PROVIDED TO DETERMINE IF INITIAL RESULTS WERE REPORTED, OR IF ANY ADVERSE EVENTS OCCURED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM CEM ROCHE DIAGNOSTICS C601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2 UNK