BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 8647530 · Received May 28, 2019

    Report

    Report Number
    1823260-2019-01985
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 9, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION DATA INDICATES THE AFFECTED REAGENT KIT WAS IN USE SINCE (B)(6) 2019. THE KIT¿S ONBOARD STABILITY EXPIRED ON 01-MAY-2019, THE VALIDITY OF PATIENT RESULTS CANNOT BE ENSURED. QC IS PERFORMED SPORADICALLY, NO VALID QC IS AVAILABLE. BASED ON THE LIMITED DATA PROVIDED, A CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE ELECSYS AMH PLUS RESULTS FOR 1 PATIENT TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER AND A COBAS 8000 E 602 MODULE. THIS MEDWATCH WILL COVER THE QUESTIONABLE RESULTS ON THE E 411. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE QUESTIONABLE RESULTS ON THE E 602. ON (B)(6) 2019 THE AMH RESULT IN A DIFFERENT LABORATORY ON THE E 602 WAS 27.7 PMOL/L. ON (B)(6) 2019 THE AMH RESULT ON THE E 411 WAS 10.11 PMOL/L. IT WAS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE AMH REAGENT LOT NUMBER ON THE E 411 WAS 369817. THE EXPIRATION DATE WAS NOT PROVIDED. THE AMH REAGENT LOT NUMBER AND EXPIRATION DATE USED ON THE E 602 WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439159 ELECSYS AMH SYSTEM ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS AMH 369817

    Patients

    Seq Age Sex Outcome Treatment
    1