BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 3172516 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03617
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE CUSTOMER. THE CALIBRATION DATA AND THE PROVIDED DATA ON LEVEL ONE QUALITY CONTROL WERE WITHIN RANGE. IT WAS NOTED THAT NOT ALL THE RACKS HAD THE RECOMMENDED ADAPTORS. IT WAS NOTED THERE WAS A REAGENT BOTTLE SWITCHOVER ON THE ANALYZER AROUND THE TIME OF THE EVENT. ADDITIONAL INFORMATION NEEDED FOR INVESTIGATION WAS REQUESTED BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS FOR ONE PATIENT ON THEIR ELECSYS 2010 ANALYZER. THE CUSTOMER STATED THIS WAS THE SECOND TIME THEY HAD SEEN THIS ISSUE IN THE LAST SIX MONTHS. THE CUSTOMER STATED THERE WAS NO FIBRIN OR CLOTS IN THE SAMPLE AND NO PROBLEMS WERE FOUND IN ANY OTHER SAMPLES. THE PATIENT'S INITIAL HCGB RESULT WAS 0.240 MIU/ML AND IT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER TESTED THE PATIENT WITH A QUICKVUE HCGB TEST STRIP AND THE RESULT WAS POSITIVE. THE PATIENT'S PRIMARY SAMPLE TUBE WAS REPEATED AND THE RESULT WAS 2121 MIU/ML ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273427 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1