BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 9513326 · Received December 23, 2019

    Report

    Report Number
    8020790-2019-00075
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Report Date
    April 6, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE UNITED ARAB EMIRATES REGARDING DISCREPANT RESULTS BETWEEN THE VIDAS® ESTRADIOL II 60 TESTS (REF(B)(4) AND ROCHE COBAS® E411 TEST METHOD FOR PATIENTS TAKING ESTROFEM. THE CUSTOMER REPORTED THAT THE ESTROFEM DRUG COULD BE INTERFERING WITH THE VIDAS RESULTS, AS THE VIDAS ESTRADIOL RESULTS WERE ELEVATED COMPARED TO THE COBAS RESULTS. THE ROCHE COBAS RESULTS WERE MORE CLINICALLY CORRELATED. A BIOMÉRIEUX INTERNAL INVESTIGATION WAS COMPLETED WITH THE FOLLOWING RESULTS: ** CUSTOMER'S MATERIAL** NO CUSTOMER'S SAMPLE AVAILABLE. **COMPLAINT TRENDING ANALYSIS** A COMPLAINT TREND ANALYSIS WAS COMPLETED FOR THE TIMEFRAME OF (B)(6) 2019 TO (B)(6) 2020 AND NO RECURRENCE OF CUSTOMER'S ISSUE (BAD CORRELATION) ON A SPECIFIC VIDAS ESTRADIOL II BATCH WAS FOUND. ** QUALITY CONTROL RECORDS ** THERE IS NO NON-CONFORMITY NOR CAPA LINKED TO THE CUSTOMER'S COMPLAINT RECORDED ON VIDAS ESTRADIOL II (REF. (B)(4). **TEST PERFORMED BY COMPLAINT LABORATORY ** COMPLAINTS LABORATORY OBSERVED INTERNAL SAMPLES CONTROL CHARTS: THIS ANALYSIS WAS CARRIED OUT : - ON 5 INTERNAL SERA WITH TARGETS SPREAD OVER THE MEASURING RANGE (TARGETS: 110-393-554-1339 AND 2362 PG/ML). - ON BATCHES MANUFACTURED SINCE 2016. ALL VIDAS ESTRADIOL II LOTS WERE IN THE TREND OF THE PARAMETER. CONCLUSION, THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE CUSTOMER'S ANOMALY NAMELY VIDAS ESTRADIOL OVERESTIMATED RESULTS. UNFORTUNATELY, WITHOUT THE CONCERNED SAMPLES AND THE CUSTOMER'S KIT, FURTHER INVESTIGATION CANNOT BE COMPLETED. A POTENTIAL ROOT CAUSE COULD BE A CROSS REACTION WITH THE HORMONAL TREATMENT, INDEED IN CASES OF ESTROGEN THERAPY, OVERESTIMATED RESULTS MAY BE OBTAINED USING VIDAS ESTRADIOL KIT. ESTROFEM IS A HORMONE REPLACEMENT THERAPY SO THIS MEDICATION COULD LEAD TO HAVE OVERESTIMATED OF ESTRADIOL DOSES AS THE DRUG IS AN EXOGEN ESTRADIOL. AS MENTIONED IN VIDAS ESTRADIOL II PACKAGE INSERT IN SECTION "RESULTS AND INTERPRETATION": "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." THE VIDAS ESTRADIOL II (REF. (B)(4)WAS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMERIEUX OF DISCREPANT RESULTS BETWEEN THE VIDAS ESTRADIOL II 60 TESTS (REF. (B)(4)) AND ROCHE COBAS E411 TEST METHOD FOR PATIENTS TAKING ESTROFEM. THE CUSTOMER REPORTED THAT THE ESTROFEM DRUG COULD BE INTERFERING WITH THE VIDAS RESULTS, AS THE VIDAS ESTRADIOL RESULTS WERE ELEVATED COMPARED TO THE COBAS RESULTS. THE ROCHE COBAS RESULTS WERE MORE CLINICALLY CORRELATED. IT SHOULD BE NOTED THAT THE VIDAS ESTRADIOL II 60 TESTS PACKAGE INSERT RESULTS AND INTERPRETATION SECTION STATES, "IN CASES OF ESTROGEN THERAPY, AND PARTICULARLY THAT OF HORMONE REPLACEMENT THERAPY 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." THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE BAD CORRELATION RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMERIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: PRODUCT REFERENCE (B)(4) IS NOT REGISTERED, SOLD OR DISTRIBUTED IN THE UNITED STATES. THE U.S.-SIMILAR REFERENCE IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307341 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMERIEUX SA

    Patients

    Seq Age Sex Outcome Treatment
    1