BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS ESTRADIOL II 60 TESTS

    MDR report key: 10718828 · Received October 22, 2020

    Report

    Report Number
    8020790-2020-00113
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Report Date
    January 21, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN INDIA REGARDING AN UNDERESTIMATED RESULT IN ASSOCIATION WITH THE VIDAS® ESTRADIOL II TEST KIT (REF 30431, LOT 1007843740) WHEN TESTING A SAMPLE FROM A PATIENT UNDERGOING IN-VITRO FERTILIZATION TREATMENT. A REQUEST WAS MADE TO OBTAIN THE CUSTOMER¿S SAMPLE FOR THE INVESTIGATION; HOWEVER, THE SAMPLE WAS NOT AVAILABLE FOR RETURN. NO MANUFACTURING ANOMALIES WERE HIGHLIGHTED DURING THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA, AND THE TESTS PERFORMED WITH THE RETAIN KIT VIDAS® ESTRADIOL II 1007843740 / 210113-0. INVESTIGATION TESTING PERFORMED ON INTERNAL AND EXTERNAL SAMPLES WITH THE RETAIN KIT OBTAINED RESULTS WITHIN THE EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBSERVED BEFORE THE BATCH RELEASE. WITHOUT THE CONCERNED PATIENT SAMPLE, BIOMÉRIEUX CANNOT PURSUE FURTHER THE INVESTIGATION TO EXPLAIN THE RESULTS OBSERVED BY THIS CUSTOMER. ACCORDING TO THE INVESTIGATION, VIDAS® ESTRADIOL II REFERENCE 30431 LOT 1007843740 / 210113-0 IS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    NOTE: REFERENCE 30431 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30431-01. A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF AN UNDERESTIMATED RESULT IN ASSOCIATION WITH THE VIDAS® ESTRADIOL II TEST KIT (REF 30431, LOT 1007843740) WHEN TESTING A SAMPLE FROM A PATIENT UNDERGOING IN-VITRO FERTILIZATION TREATMENT. INITIAL TESTING OF THE PATIENT SAMPLE USING LOT 1007843740 OBTAINED A RESULT OF 289.58 PG/ML WHICH THE PHYSICIAN SUSPECTED WAS UNDERESTIMATED. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY AND WAS TESTED USING THE CLIA TEST METHOD. A RESULT OF 673 PG/ML WAS OBTAINED. THE CUSTOMER STATED THE RESULT OF 673 PG/ML CLINICALLY CORRELATES TO THE PATIENT, AND THE RESULT OF 289.58 PG/ML OBTAINED USING LOT 1007843740 WAS UNDERESTIMATED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184824 VIDAS ESTRADIOL II 60 TESTS VIDAS® ESTRADIOL II 60 TESTS CHP BIOMERIEUX SA 1007843740

    Patients

    Seq Age Sex Outcome Treatment
    1