BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 8816643 · Received July 23, 2019

    Report

    Report Number
    8020790-2019-00038
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 3, 2018
    Report Date
    November 5, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A CUSTOMER REPORT OF FALSELY ELEVATED RESULTS FOR A 59-YEAR-OLD FEMALE IN ASSOCIATION WITH THE VIDAS® ESTRADIOL II ASSAY (REF. 30431, LOT 1006354130). THE CUSTOMER REPORTED THE RESULTS WERE DISCREPANT BETWEEN VIDAS ESTRADIOL II AND COBAS®. THE PATIENT SAMPLES WERE NOT AVAILABLE FOR SUBMITTAL FOR THE INVESTIGATION. THE INVESTIGATION INCLUDED A REVIEW OF QUALITY CONTROL RECORDS AND INTERNAL SAMPLE CONTROL CHARTS, AS WELL AS TESTING ON INTERNAL SAMPLES WITH VIDAS ESTRADIOL II LOT 1007093750 / 200108-0. VIDAS ESTRADIOL II LOT 1006354130 / 190227-0 WAS ALREADY EXPIRED BY THE TIME THE CUSTOMER NOTIFIED BIOMÉRIEUX OF THE DISCREPANT RESULTS. QUALITY CONTROL RECORDS: THE ANALYSIS OF VIDAS ESTRADIOL II BATCH 1007093750/ 200108-0 AND 1006354130 / 190227-0 SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. THERE IS NEITHER CAPA NOR NON-CONFORMITY RECORDED ON VIDAS ESTRADIOL II TEST REFERENCE 30431 LINKED TO THE CUSTOMER'S ISSUE. STUDY OF INTERNAL SAMPLES CONTROL CHARTS: THIS ANALYSIS WAS CARRIED OUT : ON FOUR INTERNAL SAMPLES WITH DIFFERENT CONCENTRATIONS (TARGETS FROM 156 TO 2179 PG/ML). ON THE TWO BATCHES MENTIONED BY THE CUSTOMER COMPARED TO SIX OTHER BATCHES. ALL THE RESULTS ARE WITHIN SPECIFICATIONS AND IN THE TREND OF THE OTHER LOTS. INTERNAL TESTING PERFORMED: INTERNAL TESTING WAS PERFORMED ON INTERNAL SAMPLES WITH THE VIDAS ESTRADIOL II ASSAY, LOT 1007093750 / 200108-0. THE COMPLAINTS LABORATORY TESTED EIGHT INTERNAL SAMPLES WITH CONCENTRATIONS FROM 24.6 TO 365 PG/ML, INCLUDING SAMPLES WITH TARGETS CLOSE TO THE RESULTS OBTAINED ON COBAS. SOME TESTING RESULTS OBSERVED A SLIGHT UPRISING OF THE RESULTS FOR THE SAMPLES WITH LOW CONCENTRATIONS. HOWEVER, THE VARIATION DOESN'T LEAD TO ANY INTERPRETATION CHANGE AND IT CANNOT EXPLAIN THE RESULTS FIVE TIMES HIGHER WITH VIDAS THAN WITH COBAS. CONCLUSION: INTERNAL TESTING WAS NOT ABLE TO DUPLICATE THE RESULTS OBSERVED BY THE CUSTOMER, AS NO PATIENT SAMPLE WAS SENT. THE HIGH CONCENTRATIONS COULD BE DUE TO AN INTERFERENCE. HOWEVER, ACCORDING TO THE MEDICAL AFFAIR ADVISOR, WITHOUT THE COMPLETE CLINICAL HISTORY OF THE PATIENT, IT IS NOT POSSIBLE TO EXPLAIN THE SAMPLES BEHAVIOR. CONSEQUENTLY, BASED ON THE INFORMATION MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS ESTRADIOL II BATCHES 1007093750 / 200108-0 AND 1006354130 / 190227-0.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSELY ELEVATED RESULTS FOR A (B)(6) YEAR OLD FEMALE IN ASSOCIATION WITH THE VIDAS® ESTRADIOL II ASSAY (REF. 30431, LOT 1006354130). VIDAS® ESTRADIOL II IS AN AUTOMATED QUANTITATIVE TEST FOR USE ON THE VIDAS FAMILY OF INSTRUMENTS FOR THE QUANTITATIVE MEASUREMENT OF TOTAL 17 BETA-ESTRADIOL IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN), USING THE ELFA TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). THE VIDAS® E2 II ASSAY IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS AND TREATMENT OF VARIOUS HORMONAL SEXUAL DISORDERS AND IN ASSESSING PLACENTAL FUNCTION IN COMPLICATED PREGNANCY. THE CUSTOMER STATED THAT THEY OBTAINED DISCREPANT RESULTS FOR A MENOPAUSAL FEMALE PATIENT BORN IN (B)(6). THE CUSTOMER, WHO IS A GYNECOLOGIST, REPORTED DISCREPANT RESULTS OF BETA-ESTRADIOL CONCENTRATION OBTAINED INTERNALLY WITH THE VIDAS ESTRADIOL II AND EXTERNALLY WITH COBAS (IN DR. STEIN LABORATORY). TWO BLOOD TUBES WERE TAKEN FROM THE PATIENT ON THE (B)(6) 2019: ONE OF THEM WAS CENTRIFUGED AND FROZEN, THE OTHER ONE WAS SENT TO THE EXTERNAL LABORATORY. THE ANALYSIS WITH THE VIDAS WAS DONE ON THE (B)(6) 2019 AND THE ANALYSIS WITH THE COBAS WAS DONE ON THE (B)(6). THE SAME CUSTOMER, WHILE REPORTING THE ISSUE OBSERVED ON (B)(6) 2019 (REFERENCE (B)(4), MEDWATCH 8020790-2019-00037), REPORTED ALSO THE FOLLOWING RESULTS OBTAINED BACK ON THE (B)(6) 2018 USING A DIFFERENT PRODUCT LOT (CURRENTLY EXPIRED): · VIDAS ESTRADIOL II (LOT NUMBER: 1006354130): 420.57 PG/ML. ON THE (B)(6) 2018 THERE WAS NO COMPLAINT REPORTED BY THE CUSTOMER; THE CUSTOMER NOTIFIED BIOMÉRIEUX ONLY UPON OBTAINING ELEVATED RESULTS DURING THE SUBSEQUENT PATIENT VISIT. FOR THE (B)(6) 2018 TESTING, THERE WAS INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THIS EVENT HAS BEEN REVIEWED FOR VIGILANCE REPORTING IN ACCORDANCE WITH 21 CFR 803, CONCERNING MEDICAL DEVICE REPORTING. THE REVIEW DETERMINED THIS EVENT MEETS THE CRITERIA FOR REPORTING AS A MALFUNCTION. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED. NOTE: PRODUCT REFERENCE 30431 IS NOT REGISTERED, SOLD OR DISTRIBUTED IN THE UNITED STATES. THE U.S.-SIMILAR REFERENCE IS 30431-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612689 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMERIEUX SA 1006354130

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR