BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMH ELECSYS E2G 100

    MDR report key: 19165279 · Received April 23, 2024

    Report

    Report Number
    1823260-2024-01247
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    January 17, 2023
    Report Date
    May 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E601 ANALYZER IS (B)(6) . THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT ISSUE CAN BE RULED OUT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS AMH ON A COBAS 6000 E601 MODULE. THE CLINICIAN DID NOT AGREE WITH THE MEASURED SAMPLE VALUE. THE SAMPLE RESULTED IN AN AMH VALUE OF 0.22 NG/ML. AFTER THE LOW VALUE, THE PATIENT WAS TREATED WITH PREGOVERIN. ON (B)(6) 2024, ANOTHER SAMPLE FROM THE PATIENT WAS TESTED, RESULTING IN AN AMH VALUE OF 4.67 NG/ML. THE CLINICIAN SUSPECTED THE VALUE FROM (B)(6) 2024 TO BE INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941993 AMH ELECSYS E2G 100 ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS 626160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female