BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 2893120 · Received January 2, 2013

    Report

    Report Number
    1823260-2013-00009
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULTS ON TWO PATIENT SAMPLES. FOR PATIENT (B)(6), THE INITIAL RESULT WAS 0.229 MUI/ML. THE TEST WAS REPEATED TWICE, WITH A RESULT OF 10,000 MUI/ML, ACCOMPANIED BY A DATA FLAG, EACH TIME. ALL TESTS WERE PROCESSED FROM THE SAME TUBE. A RESULT OF > 10,000 MUI/ML WAS REPORTED OUTSIDE THE LABORATORY. FOR PATIENT (B)(6), A FEMALE, BORN (B)(6) 1994, THE INITIAL RESULT WAS 0.300 MUI/ML. THE TEST WAS REPEATED TWICE, WITH A RESULT OF 10,000 MUI/ML, ACCOMPANIED BY A DATA FLAG, EACH TIME. ALL TESTS WERE PROCESSED FROM THE SAME TUBE. A RESULT OF > 10,000 MUI/ML WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT HARMED. THE LOT NUMBER OF THE HCG+SS REAGENT WAS 169563; THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ALARM TRACE AND FOUND MANY PROBLEMS RELATED TO THE LIQUID LEVEL DETECTION. HE PERFORMED TECHNICAL ADJUSTMENTS. SINCE THEN, NO OTHER PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR