BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 7203351 · Received January 18, 2018

    Report

    Report Number
    1823260-2018-00168
    Event Type
    Malfunction
    Date Received
    January 18, 2018
    Date of Event
    January 2, 2018
    Report Date
    February 19, 2018
    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
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THEY HAD AN ADDITIONAL PATIENT SAMPLE WITH QUESTIONABLE ANTI-MÜLLERIAN HORMONE (AMH) RESULTS. ON (B)(6) 2018, THE INITIAL RESULT WAS 3.85 NG/ML AND THE REPEAT RESULTS FROM THE REFERENCE LABORATORY WAS 7.06 NG/ML. NO INFORMATION WAS PROVIDED TO DETERMINE IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY OR IF THE PATIENT WAS ADVERSELY AFFECTED. THE METHOD USED BY THE REFERENCE LABORATORY WAS MESO SCALE DISCOVERY.

    Additional Manufacturer Narrative · 1

    AS THE REFERENCE LABORATORY METHOD WAS A MESO SCALE DISCOVERY TEST WHICH IS A CUSTOM DEVELOPED AMH TEST AND IS A RESEARCH ONLY TEST, THERE WAS NO ISSUE FOUND WITH THE ROCHE AMH ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW ANTI-MÜLLERIAN HORMONE (AMH) AND PROGESTERONE RESULTS FOR MULTIPLE PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE AMH RESULTS WERE DISCREPANT. SAMPLE 1 INITIAL RESULT WAS 0.65 NG/ML AND REPEAT RESULT WAS 0.647 NG/ML. THE TECH QUESTIONED THE LOW RESULTS AND SENT THE SAMPLE OUT TO REFERENCE LABORATORY WITH A RESULT OF 0.967 NG/ML. SAMPLE 2 INITIAL RESULT WAS 1.44 NG/ML AND A REPEAT RESULT OF 1.46 NG/ML. THE TECH QUESTIONED THE LOW RESULTS AND SENT THE SAMPLES OUT TO REFERENCE LABORATORY WITH A RESULT OF 2.14 NG/ML. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FROM THE REFERENCE LABORATORY WERE BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 23814701 WITH AN EXPIRATION DATE OF 30-APR-2018. THE FIELD SERVICE REPRESENTATIVE PERFORMED PREVENTIVE MAINTENANCE AND FOUND WORN TUBING. HE REPLACED THE TUBING AND PRIMED THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48307 ELECSYS AMH SYSTEM ANTI-MULLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS E411 DISK 23814701

    Patients

    Seq Age Sex Outcome Treatment
    1