BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 9739806 · Received February 21, 2020

    Report

    Report Number
    8020790-2020-00019
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Report Date
    April 22, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN EGYPT REGARDING A FALSELY OVERESTIMATED RESULT FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® ESTRADIOL II 60 TESTS(REF. (B)(4), LOT 1007251480). THE VIDAS® ESTRADIOL II 60 TESTS PROVIDED A RESULT OF 3457 PG/ML. THEN DILUTED THE PATIENT SAMPLE BY HALF PER THE INSTRUCTIONS FOR USE. THE RE-TEST RESULT WAS NOT PROVIDED; HOWEVER, THE CUSTOMER STATED THIS RESULT WAS ALSO TOO HIGH. THE CUSTOMER ALSO STATED THESE RESULTS DID NOT CORRELATE WITH THE PATIENT'S FOLLICLE COUNT. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: CUSTOMER'S MATERIAL. NO CUSTOMER'S SAMPLE AVAILABLE. COMPLAINT TRENDING ANALYSIS. ACCORDING TO THE COMPLAINT TREND ANALYSIS PERFORMED ON (B)(6) 2020, THERE WAS NO RECURRENCE OF CUSTOMER'S ISSUE ON VIDAS® ESTRADIOL II REF 30431 LOT 1007251480/200325-0. QUALITY CONTROL RECORDS . THE ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS® ESTRADIOL II REF 30431 LOT 1007251480/200325-0 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 1007251480/200325-0. **TEST PERFORMED BY COMPLAINT LABORATORY ** COMPLAINTS LABORATORY PERFORMED SEVERAL TESTS : 1. STUDY OF INTERNAL SAMPLES CONTROL CHARTS: THIS ANALYSIS WAS CARRIED OUT : ON FOUR (4) INTERNAL SERA WITH TARGETS BETWEEN 365 AND 2362 PG/ML. ON SEVEN (7) BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER VIDAS® ESTRADIOL II REF 30431 LOT 1007251480/200325-0. ALL VALUES WERE WITHIN SPECIFICATIONS, CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER LOTS. 2. ON INTERNAL SAMPLES: THE COMPLAINT LABORATORY TESTED A CALIBRATION AND THREE (3) INTERNAL SAMPLES (TARGETS : 365 PG/ML, 1479 PG/ML AND 2192 PG/ML) ON THE RETAIN KIT VIDAS® ESTRADIOL II 1007251480/200325-0. THE RESULTS OF CALIBRATION WERE CONFORM TO THE MLE DATA. ALL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS AND HAVE NOT EVOLVED SINCE THE CONTROL PERFORMED BEFORE BATCH RELEASE. CONCLUSION **************** 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 1007251480/200325-0. UNFORTUNATELY, WITHOUT THE CONCERNED SAMPLE, FURTHER THE INVESTIGATION CANNOT BE PURSUED TO EXPLAIN THE RESULTS OBSERVED BY THIS CUSTOMER. THE MOST LIKELY ROOT CAUSE TO CUSTOMER'S ISSUE MAY BE LINKED TO AN INTERFERENCE WITH THE PATIENT SAMPLE DUE TO A REACTION WITH THE HORMONAL TREATMENT TAKEN BY THE PATIENT FOR IVF TREATMENT. AS MENTIONED IN VIDAS® ESTRADIOL II PACKAGE INSERT : SUMMARY AND EXPLANATION : DURING OVARIAN STIMULATION FOR THE PURPOSE OF MEDICALLY ASSISTED PROCREATION, THE ASSAY OF ESTRADIOL ENABLES FOLLICULAR MATURATION TO BE MONITORED AND ASSESSED. RESULTS AND INTERPRETATION : ANY CONCENTRATION VALUES OF ESTRADIOL OBTAINED SHOULD BE USED FOR DIAGNOSIS IN ASSOCIATION WITH ADDITIONAL INFORMATION GATHERED BY THE PHYSICIAN (PATIENT QUESTIONING, CURRENT DRUG THERAPY, ULTRASOUND SCAN, CLINICAL OBSERVATIONS, OTHER EXAMINATIONS, ETC.). IN CASES OF ESTROGEN THERAPY, AND PARTICULARLY THAT OF HORMONE REPLACEMENT THERAPY (MENOPAUSE), OVERESTIMATED RESULTS MAY BE OBTAINED. LIMITATIONS OF THE METHOD - DO NOT USE THE VIDAS® ESTRADIOL II ASSAY TO MEASURE ESTRADIOL LEVELS IN PATIENTS UNDERGOING FULVESTRANT THERAPY. - INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED. CONSIDERING ALL THE DATA ABOVE, THERE WAS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® ESTRADIOL II REF 30431 LOT 1007251480/200325-0.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSELY OVERESTIMATED RESULT FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® ESTRADIOL II 60 TESTS (REF. 30431, LOT 1007251480). THE VIDAS® ESTRADIOL II 60 TESTS PROVIDED A RESULT OF 3457 PG/ML. THEN DILUTED THE PATIENT SAMPLE BY HALF PER THE INSTRUCTIONS FOR USE. THE RE-TEST RESULT WAS NOT PROVIDED; HOWEVER, THE CUSTOMER STATED THIS RESULT WAS ALSO TOO HIGH. THE CUSTOMER ALSO STATED THESE RESULTS DID NOT CORRELATE WITH THE PATIENT'S FOLLICLE COUNT. THE CUSTOMER CONFIRMED THE VIDAS RESULT WAS REPORTED TO THE TREATING PHYSICIAN, HOWEVER THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT VIDAS RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION. NOTE: REFERENCE 30431 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30431-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203249 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMERIEUX SA 1007251480

    Patients

    Seq Age Sex Outcome Treatment
    1