BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 8179633 · Received December 19, 2018

    Report

    Report Number
    1823260-2018-05009
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    September 14, 2018
    Report Date
    January 14, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION LOT NUMBER, EXPIRATION DATE, AND SERIAL NUMBER WERE UPDATED. A REVIEW OF THE CALIBRATION TRACE FROM THE ANALYZER SUGGESTS THE CUSTOMER MANIPULATED THE DATE IN THE SYSTEM SOFTWARE IN ORDER TO USE EXPIRED REAGENTS. A QC PRINTOUT FROM THE ANALYZER WITH A DATE OF (B)(6) 2018 CONTAINED A HANDWRITTEN DATE OF (B)(6) 2018, FURTHER SUPPORTING THE CONCLUSION THE CUSTOMER CHANGED THE SYSTEM DATE. 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 CUSTOMER COMPLAINED OF A QUESTIONABLE ELECSYS AMH RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). THE INITIAL AMH RESULT ON THE E 411 WAS 2.74 PMOL/L. ON (B)(6) 2018 THE SAMPLE WAS REPEATED IN A DIFFERENT LABORATORY AND THE AMH RESULT 30.3 PMOL/L. THE SPECIFIC ANALYZER WAS ASKED FOR BUT NOT PROVIDED. THE CUSTOMER DID NOT BELIEVE THAT THE RESULT ON THE E 411 WAS CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022468 ELECSYS AMH SYSTEM ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS NA 238131

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR