BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1203485 · Received October 17, 2008

    Report

    Report Number
    1823260-2008-07728
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT HCG RESULTS FOR ONE PT. INITIAL RESULT >10000 MIU/ML ACCOMPANIED BY A DATA FLAG INSTRUCTING THE USER TO DILUTE AND RERUN THE SAMPLE. SAME SAMPLE DILUTED AND REPEATED NINE TIMES GAVE <50.00 UIU/ML, 96.62 MIU/UL, 29996 MIU/ML, 27718 MIU/ML, 28664 MIU/ML, 28136 MIU/ML, 28126 MIU/ML, 28876 MIU/ML AND 28931 MIU/ML. USER STATED RESULTS WERE NOT REPORTED UNTIL THEY WERE SURE RESULTS WERE CORRECT. PT WAS NOT AFFECTED. USER SPOKE WITH DR BEFORE ANYTHING WAS DONE. THE FIELD SERVICE REP DETERMINED A MISALIGNED S/R PROBE TO BE THE CAUSE, AND HE ALIGNED THE PROBE. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK