BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 6543632 · Received May 4, 2017

    Report

    Report Number
    1823260-2017-00948
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    February 2, 2017
    Report Date
    May 22, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    ON AN UNSPECIFIED DATE, THE PATIENT HAD ANOTHER AMH RESULT FROM ANOTHER LABORATORY USING A BECKMAN-COULTER METHOD THAT WAS MORE CONSISTENT WITH THE PATIENT'S CLINICAL STATUS. THE RESULT WAS 1.65 NG/ML. THE E411 SERIAL NUMBER IS (B)(4). ON (B)(6) 2016, THE PATIENT HAD AN AMH RESULT OF 0.410 NG/ML; AN ESTRADIOL RESULT OF 301 PG/ML; AND A PROGESTERONE RESULT OF 29.90 NG/ML. ON (B)(6) 2017, THE PATIENT HAD AN ESTRADIOL RESULT OF 163 PG/ML. ON (B)(6) 2017, THE PATIENT HAD AN AMH RESULT OF 1.16 NG/ML AND A TSH RESULT OF 0.840 UIU/ML. THE FOLLOWING IS ADDITIONAL INFORMATION: CALIBRATION WAS OVERDUE BY SEVERAL MONTHS. QC WAS ACCEPTABLE ON THE DATE OF THE EVENT. AN ASSAY PERFORMANCE CHECK FROM SEPTEMBER 2016 WAS WITHIN SPECIFICATIONS. BASED UPON THIS INFORMATION, A GENERAL REAGENT ISSUE IS NOT LIKELY. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS EVENT. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE MOST LIKELY ROOT CAUSE IS A NON-REPRODUCIBLE, FALSE LOW RESULT DUE TO POOR SAMPLE QUALITY (CLOTS/FIBRIN OR BUBBLES IN THE SAMPLE); SAMPLE MIX-UP; AND/OR INSUFFICIENT MAINTENANCE. A RECOVERY ISSUE BETWEEN THE ROCHE AND BECKMAN-COULTER METHODS CANNOT BE EXCLUDED, BUT IS NOT VERY LIKELY. THE CUSTOMER WAS ADVISED TO CALIBRATE THE INSTRUMENT AT THE REQUIRED FREQUENCY, AND TO MONITOR SAMPLE PREPARATION AND INSTRUMENT HANDLING PROCESSES.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE USING THE ELECSYS AMH ASSAY ON THE COBAS E 411 IMMUNOASSAY ANALYZER (E411). THE RESULT WAS 0.162 NG/ML. THIS RESULT WAS RELEASED OUTSIDE OF THE LABORATORY. THE PHYSICIAN CONSIDERED THIS RESULT INCONSISTENT WITH THE PATIENT'S CLINICAL STATUS. ON AN UNSPECIFIED DATE, THE PATIENT HAD ANOTHER AMH RESULT FROM ANOTHER LABORATORY THAT WAS MORE CONSISTENT WITH THE PATIENT'S CLINICAL STATUS. THE RESULT AND LABORATORY METHOD USED WERE NOT PROVIDED. THE SAMPLE WAS NO LONGER AVAILABLE FOR TESTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THE PATIENT. THE E411 SERIAL NUMBER WAS NOT PROVIDED. INVESTIGATION ACTIVITIES ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325170 ELECSYS AMH SYSTEM ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS NA 189115

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR