BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1200098 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07623
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    August 29, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A NEGATIVE HCG FOR ONE FERTILITY CLINIC PT. INITIAL RESULT 0.956 MIU/ML, REPEATED TWICE GAVE 1933 AND 1813 MIU/ML. INITIAL RESULT WAS REPORTED. THE PT BELIEVED SHE WAS PREGNANT SO THE TEST WAS RERUN AND FOUND TO BE POSITIVE, A CORRECTED REPORT WAS SENT. THE PT WAS NOT ADVERSELY AFFECTED. TROUBLESHOOTING DETERMINED THE CUSTOMER WAS USING 13 MM TUBES. THE USER WAS INSTRUCTED TO USE RACK INSERTS AS RECOMMENDED IN LABELING WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E411 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR