BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 3531025 · Received December 20, 2013

    Report

    Report Number
    1823260-2013-07816
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    December 12, 2013
    Report Date
    January 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN RANGE AND NO REAGENT ISSUE WAS EVIDENT. IT WAS NOTED THE CUSTOMER MIGHT NOT HAVE BEEN FOLLOWING THE TUBE MANUFACTURER'S CLOTTING RECOMMENDATIONS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE ESTRADIOL RESULT ON THEIR ELECSYS 2010 ANALYZER FOR ONE PATIENT. THE PATIENT'S INITIAL ESTRADIOL RESULT WAS 774.3 PMOL/L AND IT WAS REPORTED TO OUTSIDE THE LABORATORY. THE DOCTOR QUERIED THE RESULT AND THE SAMPLE WAS REPEATED TWICE. ON (B)(6) 2013, THE REPEAT RESULTS WERE 4284 PMOL/L AND 4372 PMOL/L. THE REPORT WAS AMENDED TO 4280 PMOL/L AND THE DOCTOR NOTIFIED. IT WAS UNKNOWN IF THE PATIENT WAS HARMED BY THIS EVENT. INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE ESTRADIOL REAGENT LOT NUMBER WAS 173677. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668514 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR