BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMH ELECSYS E2G 100

    MDR report key: 16492068 · Received March 6, 2023

    Report

    Report Number
    1823260-2023-00699
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    January 20, 2023
    Report Date
    April 25, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    H6 CODES WERE UPDATED. THE INVESTIGATION DETERMINED THAT BASED ON THE AVAILABLE INFORMATION AND DATA, THE ROOT CAUSE FOR THE OBSERVED DISCREPANCIES CANNOT BE IDENTIFIED. HOWEVER, BASED ON THE RESULT CONSTELLATIONS OF REPRODUCIBLE CLEARLY DIFFERENT AMH RESULTS FOR THE SAME PATIENT AND SAME DRAW AT THE 2 SITES, A MIXING UP OF SAMPLES SHOULD BE LOCALLY CONSIDERED AS A POSSIBLE ROOT CAUSE. A PIPETTING ISSUE WITH THE FIRST RESULTS (NON-REPRODUCIBLE FALSE LOW RESULTS) CANNOT BE ENTIRELY EXCLUDED. NO GENERIC REAGENT ISSUE WAS FOUND.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT TESTED WITH ELECSYS AMH ASSAY ON A COBAS 6000 E 601 MODULE (SERIAL NUMBER (B)(4)). THE INITIAL RESULT WAS 0.773 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE PATIENT COMPLAINED. ON (B)(6) 2023 THE PATIENT WENT TO A DIFFERENT LABORATORY (LABORATORY A) WHERE THE RESULT WAS 25 NG/ML. ON (B)(6) 2023 THE REPEAT RESULT FROM THE E 601 MODULE WAS 0.777 NG/ML. THE CUSTOMER SENT THE SAMPLE TO 2 DIFFERENT LABORATORIES USING THE ROCHE METHOD. THE RESULT FROM LABORATORY B WAS 16.5 NG/ML. THE RESULT FROM LABORATORY C WAS 25 NG/ML. THE HIGHER RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63276 AMH ELECSYS E2G 100 ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS NA 62615700

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female