BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3766309 · Received April 23, 2014

    Report

    Report Number
    1823260-2014-02982
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 14, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION NEEDED FOR FURTHER 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 A QUESTIONABLE ESTRADIOL RESULT FOR ONE PATIENT ON THEIR E-MODULE. THE CUSTOMER STATED NO OTHER SAMPLES EXHIBITED THIS PROBLEM THROUGHOUT THE USE OF THE REAGENT KIT. THE PATIENT'S INITIAL ESTRADIOL RESULT WAS 5.0 PG/ML. THE DOCTOR RECEIVED THE INITIAL RESULT AND QUESTIONED IT. THE SAMPLE ALSO PRODUCED AN ESTRADIOL RESULT OF 506.5 PG/ML. THE SECOND RESULT WAS VERIFIED WITH A RESULT OF 479 PG/ML. INFORMATION ON WHETHER THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE ESTRADIOL REAGENT LOT NUMBER WAS 173677 AND THE EXPIRATION DATE WAS 09/30/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247157 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1