BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 8798011 · Received July 17, 2019

    Report

    Report Number
    1823260-2019-02632
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE RAN PRECISION AND ANALYZER PERFORMANCE TESTING WHICH WAS ACCEPTABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. PRODUCT LABELING FOR THE ASSAY STATES "THE MEASURED AMH VALUE OF A PATIENT¿S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. THE LABORATORY FINDING MUST, THEREFORE, ALWAYS CONTAIN A STATEMENT ON THE AMH ASSAY METHOD USED."

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE LOW AMH ELECSYS RESULTS FOR ONE PATIENT FROM THE COBAS E411 RACK ANALYZER WHICH DID NOT MATCH THE CLINICAL HISTORY OF THE PATIENT. IN THE FALL OF 2018, THE PATIENT'S AMH RESULT WAS AT 3.1 NG/ML. ON (B)(6) 2019 (DAY PRIOR TO START OF MENSTRUATION), THE ORIGINAL RESULT WAS 0.030 NG/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 0.897 NG/ML. ON (B)(6) 2019 (START OF MENSTRUATION), A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND THE RESULT WAS 0.870 NG/ML. THE LABORATORY HAD THE CUSTOMER GO TO HER PRIMARY CARE PHYSICIAN FOR BLOODWORK AT ANOTHER LABORATORY. THE RESULT FOR THAT SAMPLE WAS 5.36 NG/ML. THE CUSTOMER DID NOT KNOW THE METHOD USED. ON (B)(6) 2019, A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT WAS 2.09 NG/ML. THIS SAMPLE WAS SENT TO ANOTHER LABORATORY FOR RETESTING AND THE RESULT WAS AROUND 3.00 NG/ML. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E411 RACK ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590953 ELECSYS AMH SYSTEM ANTI-MULLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS AMH 36980900

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR "PRENATAL VITAMIN"| POSSIBLE "ANXIETY MEDICATION"| PROBIOTIC| ZOLOFT