BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 9885486 · Received March 26, 2020

    Report

    Report Number
    1823260-2020-00858
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    December 19, 2019
    Report Date
    March 26, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROLS WERE WITHIN RANGE, SHOWING NO INDICATION OF A REAGENT OR INSTRUMENT PERFORMANCE ISSUE. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS AMH PLUS ASSAY ON A COBAS 8000 E 602 MODULE. AN ALIQUOT OF THE SAMPLE INITIALLY RESULTED WITH AN AMH VALUE OF LESS THAN 0.1 PMOL/L WHEN TESTED ON THE E 801 ANALYZER. THE VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. AT A DIFFERENT LABORATORY USING AN UNKNOWN METHOD, A SAMPLE FROM THE PATIENT WAS TESTED FOR AMH AND THE RESULT WAS 56 PMOL/L. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE 56 PMOL/L VALUE WAS MEASURED FROM THE SAME PATIENT SAMPLE OR IF IT WAS MEASURED FROM A DIFFERENT SAMPLE COLLECTED FROM THE PATIENT AT A DIFFERENT TIME. THE E 801 ANALYZER SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349193 ELECSYS AMH SYSTEM ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS AMH PLUS 40818501

    Patients

    Seq Age Sex Outcome Treatment
    1