BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH

    MDR report key: 15831363 · Received November 20, 2022

    Report

    Report Number
    1823260-2022-03691
    Event Type
    Malfunction
    Date Received
    November 20, 2022
    Date of Event
    October 21, 2022
    Report Date
    January 20, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS REPEATED CALIBRATION AND CHANGED THE REAGENT, BUT THE RESULTS ARE STILL RECOVERING LOW. THE FIELD SERVICE ENGINEER COULD NOT DETERMINE A CAUSE.

    Additional Manufacturer Narrative · 0

    FOR THE LAST CALIBRATION PERFORMED ON (B)(6)-2022 THERE WAS AN ALARM INDICATING A LOT CALIBRATION COULD NOT BE GENERATED AND IT WAS RELEASED AS A REAGENT PACK CALIBRATION. CONTROLS WERE OUTSIDE OF RANGE. THE SAMPLE CLOTTING TIME WAS SHORTER THAN RECOMMENDED BY THE TUBE MANUFACTURER. THE FIELD SERVICE ENGINEER RAN PERFORMANCE TESTING. THE INVESTIGATION DETERMINED THE CUSTOMER'S ACTIONS OF INSTALLING A NEW REAGENT PACK AND REPEATING THE SAMPLES RESOLVED THE ISSUE. A VALID CALIBRATION WAS ESTABLISHED WITH THE NEW REAGENT PACK AND CONTROLS WERE WITHIN RANGE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS AMH ON A COBAS E 411 IMMUNOASSAY ANALYZER. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE CAME FROM A DONOR AND INITIALLY RESULTED IN AN AMH VALUE OF 1.79 NG/ML. THE CUSTOMER QUESTIONED THE RESULT BECAUSE DONORS TYPICALLY HAVE HIGHER AMH RESULTS. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING WITH AN UNKNOWN AMH METHOD, RESULTING IN A VALUE OF 2.47 NG/ML. THE REPEAT VALUE WAS DEEMED CORRECT. THE SERIAL NUMBER OF THE E411 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465043 ELECSYS AMH ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female