BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010

    MDR report key: 964220 · Received December 13, 2007

    Report

    Report Number
    1823260-2007-10717
    Event Type
    Malfunction
    Date Received
    December 13, 2007
    Date of Event
    November 7, 2007
    Report Date
    December 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH INITIAL RBC FOLATE RESULT OF 705 UG/L AND FOLATE IN SERUM RESULT OF >06UG/L, DO NOT MATCH THE CLINICAL PICTURE. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER - DIFFERENT METHODOLOGY GIVING RBC FOLATE RESULT OF >17.5 UG/L AND FOLATE IN SERUM RESULT OF 1.41 UG/L. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS CORP. E2010

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR