BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH

    MDR report key: 21305729 · Received February 4, 2025

    Report

    Report Number
    1823260-2025-00326
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 11, 2025
    Report Date
    March 7, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    UDI-DI
    07613336166291
    PMA / PMN Number
    DEN150057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E402 ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. NO SAMPLE INVERSIONS WERE PERFORMED AND THE CUSTOMER USED A CLOTTING TIME OF "UP TO 15 MINUTES." THE CUSTOMER USED A CENTRIFUGATION TIME OF 5 MINUTES AT A SPEED OF 4000 REVOLUTIONS PER MINUTE (RPM). THE CLOTTING AND CENTRIFUGATION TIMES MAY BE TOO SHORT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE (NO TUBE INVERSIONS AFTER DRAW, TOO SHORT CLOTTING TIME AND POSSIBLY IMPROPER CENTRIFUGATION).

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS AMH (AMH) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 17.4 NG/ML. THE REPEAT RESULT WAS < 0.0100 NG/ML WITH A DATA FLAG. THE PATIENT WAS TESTED IN A DIFFERENT LABORATORY AND THE RESULT FROM THE MAGLUMI METHOD WAS 0.049 NG/ML. THE ORIGINAL SAMPLE WAS REPEATED AT THE LABORATORY USING THE MAGLUMI METHOD AND THE REPEAT RESULT WAS 0.056 NG/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094379 ELECSYS AMH ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS 786819 07613336166291

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female