BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1003480 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01742
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING ELEVATED CKMB RESULTS WHEN COMPARED TO ANOTHER ANALYZER - SAME METHODOLOGY SINCE 6/1/07. THE FOLLOWING EXAMPLES WERE PROVIDED, WHICH OCCURRED (B)(6) 2008: SAMPLE 1, INITIAL RESULT GAVE 1.31 NG/ML; REPEAT GAVE 1.96 NG/ML. SAMPLE 2, INITIAL GAVE 2.50 NG/ML; REPEAT GAVE 3.05 NG/ML. SAMPLE 3, INITIAL RESULT GAVE 1.81 NG/ML; REPEAT GAVE 2.51 NG/ML. NO ERRONEOUS RESULTS REPORTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATIONS WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER -JJE JJE ROCHE DIAGNOSTICS 2010 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK