BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1745962 · Received August 3, 2007

    Report

    Report Number
    1823260-2007-06827
    Event Type
    Malfunction
    Date Received
    August 3, 2007
    Date of Event
    July 15, 2007
    Report Date
    August 3, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT A SAMPLE INITIALLY REPORTED AS NEGATIVE FOR HCG AND WHEN REPEATED GAVE RESULTS OF 99.93, 102.6 AND 106.5 MIU/ML. THE PATIENT WAS REDRAWN AND THE SAMPLE GAVE HCG RESULTS OF 109.0, 110.8 AND 116.0 MIU/ML. PATIENT SAMPLE WAS RUN ON AN ALTERNATIVE METHOD WHICH REPORTED A POSITIVE FOR HGC. THE ACCOUNT DID NOT REPORT ANY ADVERSE EVENTS RELATED TO THE INCORRECT RESULT. THE FIELD SERVICE REP FOUND THE PINCH TUBING WAS WORN AND REPAIRED THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR