BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 13509796 · Received February 10, 2022

    Report

    Report Number
    8020790-2022-00031
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Report Date
    March 24, 2022
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMERIEUX INVESTIGATION WAS PERFORMED, FOLLOWING NOTIFICATION FROM A CUSTOMER IN ITALY, OF OBTAINING OVERESTIMATED RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS® ESTRADIOL II 60 TESTS (REF. 30431, BATCH NUMBER 1008935140, EXPIRY DATE 23-AUG-2022) COMPARED TO ANOTHER METHOD (ARCHITECT). CUSTOMER CONFIRMED THE PATIENT IS UNDERGOING MEDICAL TREATMENT WITH PROGYNOVA. INVESTIGATION COMPLAINT ANALYSIS THE COMPLAINT ANALYSIS FOUND NO RECURRENCE OF CUSTOMER¿S ISSUE ON VIDAS ESTRADIOL II REF 30431 LOT 1008935140. QUALITY CONTROL RECORDS THE ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS ESTRADIOL II REF 30431 LOT 1008935140 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. NO NON-CONFORMITY NOR CAPA LINKED TO THE CUSTOMER¿S COMPLAINT RECORDED ON VIDAS ESTRADIOL II REF 30431 LOT 1008935140. TEST PERFORMED BY COMPLAINT LABORATORY CUSTOMER'S PATIENT SAMPLES WERE NOT AVAILABLE FOR THE INVESTIGATION. INTERNAL SAMPLE CONTROL CHARTS WERE ANALYZED ON FOUR (4) INTERNAL SERA WITH TARGETS BETWEEN 268PG/ML AND 777PG/ML, USING SEVEN (7) LOT NUMBERS (INCLUDING THE CUSTOMER'S LOT). ALL VALUES WERE WITHIN SPECIFICATIONS AND THE CUSTOMER'S LOT WAS CONSISTENT WITH THE OTHERS. THE COMPLAINTS LABORATORY THEN TESTED THREE (3) INTERNAL SAMPLES (TARGETS BETWEEN 156 PG/ML TO 777 PG/ML) ON RETAIN KITS FOR THE CUSTOMER'S LOT AND ANOTHER BATCH (USED AS REFERENCE). ALL RESULTS WERE WITHIN SPECIFICATIONS AND WERE SIMILAR TO THOSE OBSERVED BEFORE BATCH RELEASE, INDICATING THERE IS NO DRIFT IN RESULTS OVER TIME. ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS , THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED WITH THE RETAIN KIT VIDAS ESTRADIOL II 1008935140/ 220823. WITHOUT THE CONCERNED SAMPLE, FURTHER INVESTIGATION CANNOT BE PURSUED TO EXPLAIN THE RESULTS OBSERVED BY THIS CUSTOMER. THE HIGH RESULT COULD BE A CROSS REACTION WITH THE HORMONAL MEDICATION, IN THE CONTEXT OF THE PATIENT'S IVF TREATMENT (PROGYNOVA). PROGYNOVA IS AN HORMONE REPLACEMENT THERAPY BASED ON EXOGENEOUS SUPPLY OF ESTRADIOL AND THIS MEDICATION MAY LEAD TO OVERESTIMATED CONCENTRATIONS OF ESTRADIOL. THE VIDAS ESTRADIOL II PACKAGE INSERT (SECTION ¿RESULTS AND INTERPRETATION¿) STATES: ¿IN CASES OF ESTROGEN THERAPY, AND PARTICULARLY THAT OF HORMONE REPLACEMENT THERAPY (MENOPAUSE), OVERESTIMATED RESULTS MAY BE OBTAINED. INTERPRETATION OF TEST RESULTS SHOULD BE MADE TAKING INTO CONSIDERATION THE PATIENT'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED.¿ ACCORDING TO ALL THE DATA ABOVE, VIDAS ESTRADIOL II REFERENCE 30431 LOT 1008935140 IS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 0

    ISSUE DESCRIPTION. ON (B)(6) 2022, A CUSTOMER FROM ITALY NOTIFIED BIOMÉRIEUX OF OBTAINING OVERESTIMATED RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS ESTRADIOL II 60 TESTS (REF. 30431, BATCH NUMBER 1008935140, EXPIRY DATE 23-AUG-2022) COMPARED TO ANOTHER METHOD (ARCHITECT). THE CUSTOMER TESTED TWO WOMEN WITH TWO DIFFERENT METHODS AND OBTAINED THE FOLLOWING RESULTS: PATIENT 1: MINIVIDAS: 1010.66 PG/ML VS ARCHITECT 182 PG/ML. PATIENT 2: MINIVIDAS: 2596.15 PG/ML VS ARCHITECT 738 PG/ML. TO BE NOTED, BOTH WOMEN WERE UNDER STIMULATION WITH THE DRUG PROGYNOVA. THE CUSTOMER DID NOT REPORT THESE RESULTS TO THE PATIENT, BUT DID CLAIM A DELAY IN RENDERING RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798789 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMERIEUX SA 1008935140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown