BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS AMH

    MDR report key: 15633181 · Received October 19, 2022

    Report

    Report Number
    1823260-2022-03255
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 8, 2022
    Report Date
    November 14, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    PQO
    UDI-DI
    04015630940363
    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 LAST CALIBRATION PERFORMED ON 14-AUG-2022 WAS WITHIN SPECIFICATIONS. THE QC RECOVERY WAS WITHIN -2SD AND WITHIN SPECIFICATIONS. THERE IS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE CUSTOMER SENT OUT NEW SAMPLES FOR FURTHER COMPARISON TESTING AND FOUND THEM ALL TO BE WITHIN THEIR LABORATORY'S ACCEPTABLE LIMITS. AFTER THE INSTRUMENT'S PERFORMANCE WAS VERIFIED, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER.  THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND DID NOT FIND ANY HARDWARE ISSUES. HE THEN PERFORMED AN INSTRUMENT CHECK WITH ACCEPTABLE RESULTS. HE DID NOT PERFORM ANY REPAIRS. THE CUSTOMER PERFORMED QC WITH ACCEPTABLE RESULTS. THE ANALYZER'S PERFORMANCE WAS VERIFIED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS AMH (AMH) RESULTS FOR TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER WAS PERFORMING A QC INVESTIGATION FOR LOW BIAS OF THE AMH ASSAY. THE REPORTER USED OLD PROFICIENCY MATERIAL FOR REPEATS AND IT WAS CONFIRMED THAT THERE WAS A LOW BIAS. THE REPORTER THEN SENT OUT THE PATIENT SAMPLES TO A LABORATORY THAT USES A ROCHE ELECSYS ANALYZER FOR A SPLIT-SAMPLE ANALYSIS. PATIENT 1: THE INITIAL RESULT FROM THE ANALYZER WAS 6.83 NG/ML. THE REPEAT RESULT FROM THE OTHER LABORATORY WAS 11.61 NG/ML. PATIENT 2: THE INITIAL RESULT FROM THE ANALYZER WAS 12.1 NG/ML. THE REPEAT RESULT FROM THE OTHER LABORATORY WAS 35.3 NG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176445 ELECSYS AMH ANTI-MÜLLERIAN HORMONE TEST SYSTEM PQO ROCHE DIAGNOSTICS NA 58177701 04015630940363

    Patients

    Seq Age Sex Outcome Treatment
    1 Female