BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 8514997 · Received April 15, 2019

    Report

    Report Number
    1823260-2019-01464
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    January 25, 2019
    Report Date
    June 7, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT PERFORMANCE TESTING WAS WITHIN SPECIFICATION AFTER THE EVENT. THE INVESTIGATION DETERMINED THE SAMPLE INVERSION, CLOTTING TIME, AND CENTRIFUGATION SPEED WERE INSUFFICIENT FOR THE TUBE TYPE. THE CUSTOMER DID NOT USE RACK ADAPTERS WHICH ARE REQUIRED FOR USE WITH 13 MM. DIAMETER TUBES. THE PROVIDED ALARM TRACE CONTAINS SEVERAL SAMPLE LIQUID LEVEL DETECTION ALARMS WHICH INDICATES A POSSIBLE SAMPLE QUALITY ISSUE. BASED ON THE PROVIDED DATA, A GENERAL REAGENT ISSUE IS NOT EVIDENT. 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 COMPLAINED OF HIGH RESULTS NOT MATCHING THE CLINICAL PICTURE FOR 2 PATIENTS TESTED FOR ELECSYS AMH PLUS (AMH PLUS) ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE HIGH RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR STATED THE RESULTS WERE NOT POSSIBLE. THE CUSTOMER NOTED THAT THE PATIENTS WERE NOT TAKING THE MEDICATION REKOVELLE. IT IS NOT CLEAR HOW THIS RELATES TO THE QUESTIONABLE AMH PLUS RESULTS. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE CUSTOMER'S CALIBRATION FREQUENCY IS VERY LOW. THE CUSTOMER HAS NOT PROVIDED ANY QC DATA FROM THE TIME OF THE PATIENT RESULTS. THE QC DATA THAT WAS PROVIDED SHOWS VERY HIGH RESULTS WITH SUBOPTIMAL RECOVERY. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE CUSTOMER USES 13 MM SAMPLE TUBES WITH NO RACK ADAPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309287 ELECSYS AMH SYSTEM ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS AMH 329422

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR