BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH SYSTEM

    MDR report key: 6823648 · Received August 28, 2017

    Report

    Report Number
    1823260-2017-01830
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 3, 2017
    Report Date
    September 20, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    PMA / PMN Number
    DEN150057
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THERE WAS AN ADDITIONAL 0.536 NG/ML VALUE FROM THE E411 ANALYZER ON (B)(6) 2017. IT WAS CONFIRMED THAT ONLY THE VALUE OF 7.34 NG/ML WAS OBTAINED FROM THE E601 ANALYZER AT THE OTHER SITE ON (B)(6) 2017. IT WAS CONFIRMED THAT THE VALUE OF 7 NG/ML FROM THE E411 ANALYZER ON AN UNKNOWN DATE WAS ACTUALLY AN APPROXIMATION OF THE 7.22 NG/ML VALUE OBTAINED ON THE E411 ANALYZER ON (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE PROVIDED CALIBRATION DATA, A CALIBRATION DATE OF (B)(6) 2016 WAS SEEN. THIS SUGGESTS THAT THE DATE/TIME SETTING ON THE ANALYZER MAY HAVE BEEN MANIPULATED. CALIBRATION SIGNALS WERE IMPLAUSIBLE AND TOO HIGH, ESPECIALLY FOR CALIBRATOR LEVEL 1. RE-CALIBRATION GAVE LOWER, BUT STILL UNEXPECTED HIGH SIGNALS. CALIBRATION IS LIKELY TO IMPACT PATIENT AND QUALITY CONTROL RESULTS, BUT IS UNLIKELY TO HAVE CAUSED THE ERRONEOUS RESULT OF 0.536 NG/ML. THE PROVIDED CONTROL RESULTS SHOWED OUT OF RANGE RECOVERIES. IT WAS UNCLEAR IF CONTROL MEASUREMENTS WERE PERFORMED ON (B)(6) 2017 SINCE RESULT DATES AND TIMES WERE MISSING. REAGENT PERFORMANCE ON THE DAY OF THE EVENT IS QUESTIONABLE. THE REAGENT MAY HAVE BEEN UNSUITABLE FOR PATIENT SAMPLE MEASUREMENT. COAGULATION TIME OF THE SAMPLE WAS INSUFFICIENT. NO FIBRIN OR CLOTS WERE PRESENT IN THE SAMPLE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE SAMPLE QUALITY AND INSUFFICIENT MAINTENANCE.

    Description of Event or Problem · 1

    THE CUSTOMER SUCCESSFULLY CALIBRATED A NEW ELECSYS AMH (AMH) REAGENT PACK ON THE COBAS E 411 IMMUNOASSAY ANALYZER (E411) WITH SERIAL NUMBER (B)(4). BOTH LEVELS OF QUALITY CONTROLS WERE TESTED AND THESE WERE WITHIN RANGE. THE CUSTOMER STARTED TESTING PATIENT SAMPLES AND THE LABORATORY DIRECTOR NOTICED THAT MANY PATIENTS SAMPLES HAD LOW AMH LEVELS EVEN THOUGH THE PATIENTS WERE YOUNG IN AGE. THE LABORATORY DIRECTOR DID NOT INVESTIGATE FURTHER, KNOWING THE FERTILITY HISTORY OF THE PATIENTS. ONE PATIENT HAD AN ERRONEOUS RESULT THAT WAS QUESTIONED BY THE TREATING GYNECOLOGIST. THE PATIENT RESULT WAS TOO LOW BASED ON THE KNOWN HISTORY AND CLINICAL CONDITION OF THE PATIENT. THE SAMPLE INITIALLY RESULTED AS 0.536 NG/ML AND THIS WAS THE VALUE THAT WAS REPORTED OUTSIDE OF THE LABORATORY TO THE GYNECOLOGIST. THE SAMPLE WAS TESTED AT A DIFFERENT SITE ON A COBAS 6000 E 601 MODULE (E601) AND RESULTED AS 7.34 NG/ML ON (B)(6) 2017. THE CUSTOMER STATED THAT THE CALIBRATION SIGNALS APPEARED TO BE HIGH, SO THE LABORATORY DIRECTOR REQUESTED RE-CALIBRATION OF THE ASSAY. THE ASSAY WAS RE-CALIBRATED USING FRESHLY RECONSTITUTED CALIBRATORS. SIGNALS WERE LOWERED FOR ONE CALIBRATOR LEVEL, BUT STILL HIGHER THAN EXPECTED. FOR THE SECOND CALIBRATOR LEVEL, RECOVERY WAS HIGHER COMPARED TO THE PREVIOUS RESULT AND TARGET. THE SAMPLE WAS REPEATED ON THE E411 ANALYZER ON (B)(6) 2017, RESULTING AS 7.22 NG/ML. THE FOLLOWING ADDITIONAL SAMPLE VALUES WERE PROVIDED, BUT IT IS COULD NOT BE CLARIFIED IF THESE VALUES WERE PROVIDED IN ERROR, IF THEY WERE ADDITIONAL VALUES FROM THE PATIENT SAMPLE, OR IF THESE WERE APPROXIMATIONS OF VALUES ALREADY PROVIDED: AN ADDITIONAL 0.536 NG/ML VALUE FROM THE E411 ANALYZER ON (B)(6) 2017, A VALUE OF 7.32 NG/ML FROM THE E601 ANALYZER AT A DIFFERENT SITE ON (B)(6) 2017, AND 7 NG/ML FROM THE E411 ANALYZER ON AN UNKNOWN DATE. CLARIFICATIONS OF THIS DATA HAVE BEEN REQUESTED. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE E411 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606160 ELECSYS AMH SYSTEM ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS NA 18911501

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR