BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 101

    MDR report key: 1032932 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03482
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT PARATHYROID HORMONE RESULTS REPORTED. INITIAL RESULT 72 PG/ML, SAME SAMPLE REPEATED NINE TIMES GIVING 42, 83, 89, 49, 90, 865, 41, 62 AND 39 PG/ML. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE FOUND A CRACKED S/R SAMPLE TUBE WHICH HE REPLACED AND NOTED THE CUSTOMER HAD BEEN RUNNING ON USED ASSAY CUPS. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 101 IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR