BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 4739997 · Received April 30, 2015

    Report

    Report Number
    1823260-2015-03373
    Event Type
    Malfunction
    Date Received
    April 30, 2015
    Date of Event
    April 11, 2015
    Report Date
    May 13, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. A GENERAL INSTRUMENT OR REAGENT ISSUE IS NOT LIKELY. BASED ON THE AVAILABLE DATA, A POSSIBLE ROOT CAUSE MAY BE RELATED TO PRE-ANALYTICS. ANOTHER POSSIBLE ROOT CAUSE MAY BE RELATED TO IMPROPER ENVIRONMENTAL CONDITIONS IN THE LABORATORY.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULTS FROM ONE PATIENT SAMPLE. THE INITIAL HCG+B RESULT WAS 1.87 MIU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN CALLED TO EXPLAIN THAT THE PATIENT WAS CONFIRMED AS BEING PREGNANT BY AN ULTRASOUND. THE SAMPLE WAS REPEATED AND THE HCG+B RESULTS WERE 7587 MIU/ML AND 7647 MIU/ML. NO ADVERSE EVENT WAS REPORTED. THE HCG+B REAGENT LOT NUMBER WAS 183183. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283697 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1