BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 8515051 · Received April 15, 2019

    Report

    Report Number
    1823260-2019-01465
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    February 28, 2019
    Report Date
    July 26, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE AMH PLUS ELECSYS RESULTS FOR THREE PATIENT SAMPLES FROM ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). PATIENT 1 INITIAL RESULT WAS 1.36 NG/ML AND REPEAT RESULT WITH ANOTHER REAGENT LOT WAS 1.38 NG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2019 AND THE RESULT WAS 0.37 NG/ML. ON (B)(6) 2019, PATIENT 2 INITIAL RESULT WAS 0.88 NG/ML AND THE REPEAT RESULT WITH ANOTHER REAGENT LOT WAS 0.82 NG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2019 AND THE RESULT WAS 0.42 NG/ML. ON (B)(6) 2019, PATIENT 3 INITIAL RESULT WAS 0.50 NG/ML AND THE REPEAT RESULT WITH ANOTHER REAGENT LOT WAS 0.53 NG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2019 AND THE RESULT WAS 0.17 NG/ML. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE DOCTOR, THESE AMH RESULTS WERE CLINICALLY UNLIKELY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER SUSPECTED AN INTERFERENCE DUE TO REPEATED FREEZING AND THAWING OF THE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307006 ELECSYS AMH SYSTEM ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS AMH ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1