BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 8736348 · Received June 26, 2019

    Report

    Report Number
    8020790-2019-00035
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    May 16, 2019
    Report Date
    October 23, 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

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE REGARDING FALSELY OVER-ESTIMATED RESULTS ASSOCIATED WITH THE VIDAS® ESTRADIOL II ASSAY. BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. THREE (3) PATIENT SAMPLES WERE SUBMITTED BY THE CUSTOMER TO AID IN THE INVESTIGATION. EVALUATION OF THE MANUFACTURING QUALITY CONTROL RECORDS INDICATED THE VIDAS ESTRADIOL II LOT 1007093750 / 200108-0 HAD NO ANOMALY DURING THE MANUFACTURING CONTROL AND PACKAGING PROCESSES. STUDY OF INTERNAL SAMPLES CONTROL CHARTS SHOWED ALL THE RESULTS ARE WITHIN SPECIFICATIONS AND VIDAS ESTRADIOL II BATCH 1007093750/ 200108-0 IS IN THE TREND OF THE OTHER LOTS. THIS STUDY INCLUDED: FOUR (4) INTERNAL SAMPLES WITH DIFFERENT CONCENTRATIONS (TARGETS FROM 156 TO 2179 PG/ML). VIDAS ESTRADIOL II BATCH 1007093750/ 200108-0 MENTIONED BY THE CUSTOMER COMPARED TO SIX (6) OTHER BATCHES. INVESTIGATIONAL TESTING INCLUDED INTERNAL SAMPLES, AS WELL AS THE PATIENT SAMPLES SUBMITTED BY THE CUSTOMER. BIOMÉRIEUX TESTED NINE (9) INTERNAL SAMPLES WITH CONCENTRATIONS FROM 24.6 TO 365 PG/ML, INCLUDING FIVE (5) SAMPLES WITH TARGETS CLOSE TO THE RESULTS OBTAINED WITH THE CUSTOMER'S BECKMAN DIXIT TESTING. EVEN IF A SLIGHT INCREASE OF THE RESULTS WAS OBSERVED FOR THE SAMPLES WITH THE LOW CONCENTRATIONS, IT WAS A WEAK VARIATION WHICH DIDN'T LEAD TO AN INTERPRETATION CHANGE. THE RESULTS OBTAINED ON SAMPLES WITH TARGETS CLOSE TO THE EXPECTED CONCENTRATIONS OF THE PATIENT SAMPLES WERE COMPLIANT WITH SPECIFICATIONS. BIOMÉRIEUX TESTED THE PATIENT SAMPLES ON VIDAS ESTRADIOL II BATCH 1007093750/ 200108-0 AND OBTAINED SIMILAR RESULTS AS THOSE OBSERVED BY THE CUSTOMER [HIGH RESULTS WITH 1369.72 AND 1553.84 PG/ML FOR THE TWO (2) SAMPLES COLLECTED IN MAY AND A LOWER RESULT WITH 118.44 PG/ML FOR THE SAMPLE COLLECTED IN JUNE]. RESEARCH OF AN INTERFERENCE LINKED TO THE PRESENCE OF HETEROPHILIC ANTIBODIES USING SCANTIBODIES HBT TEST WAS PERFORMED ON THE 1ST SAMPLE. THE RESULTS OBTAINED WERE SIMILAR WITH THE UNTREATED SAMPLE, AND THE SAMPLE AFTER TREATMENT EXCLUDING THE PRESENCE OF HETEROPHILIC ANTIBODIES. THE INVESTIGATOR PERFORMED A DILUTION TEST ON THE 1ST PATIENT SAMPLE (SAMPLE DILUTED AT 1:2, 1:4, 1:8 AND 1:16). THE DILUTION TEST DIDN'T ALLOW TO ELIMINATE THE INTERFERENCE. AS AN ADDITIONAL TEST, TWO (2) CUSTOMER SAMPLES WERE SENT TO AN EXTERNAL LABORATORY TO PERFORM AN ESTRIOL TEST. THE RESULTS OBTAINED ARE THE SAME (0.2 NMOL/L) FOR EACH SAMPLE AND CONSIDERED AS NEGATIVE BY THE EXTERNAL LABORATORY. THEREFORE, THE HIGH RESULT OBSERVED ON THE SAMPLES CANNOT BE EXPLAINED BY THE PRESENCE OF ESTRIOL. NO INTERFERENCE WAS DETECTED IN RELATION TO THE PRESENCE OF HETEROPHILIC ANTIBODIES, AND THE DILUTION TEST PERFORMED DID NOT ALLOW TO ELIMINATE ANY INTERFERENCE. THE OVERESTIMATED RESULTS CANNOT BE LINKED TO THE PRESENCE OF ESTRIOL. THE SAMPLES WERE TESTED IN THE SAME CONDITIONS USING VIDAS ESTRADIOL II BATCH 1007093750/ 200108-0 (BATCH USED BY THE CUSTOMER), SO WE CAN SUSPECT THAT THE HIGH CONCENTRATIONS OBSERVED ARE LINKED TO THE SAMPLES THEMSELVES. ACCORDING TO THE MEDICAL AFFAIR ADVISOR, WITHOUT THE COMPLETE CLINICAL HISTORY OF THE PATIENT, IT IS NOT POSSIBLE TO EXPLAIN THE SAMPLES BEHAVIOR.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSELY OVER-ESTIMATED RESULT IN ASSOCIATION WITH THE VIDAS® ESTRADIOL II ASSAY (REF. 30431, LOT 1007093750).THE CUSTOMER STATED THE PATIENT IS UNDER TREATMENT WITH FERTISTARTKIT®. VIDAS ESTRADIOL II TEST RESULTS FOR THE PATIENT ARE AS FOLLOWS: INITIAL TEST ON (B)(6) 2019 AT 11:45 - 552 RFV 1528.74PG / ML, RETEST ON (B)(6) 2019 AT 9:45 - 579 RFV 1437.39PG / ML, TEST OF NEW SAMPLE OBTAINED (B)(6) 2019 - 1590.01. TESTING VIA BECKMAN DIXIT OBTAINED RESULTS OF 200PG / ML TWICE. TEST OF NEW SAMPLE OBTAINED (B)(6) 2019 - 216.40. THE PATIENT SAMPLES WILL BE SUBMITTED FOR INVESTIGATION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR TREATING PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED. NOTE: ALTHOUGH PRODUCT REFERENCE 30431 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES, A SIMILAR PRODUCT (REF. 30431-01) IS REGISTERED/SOLD IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531475 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMERIEUX SA 1007093750

    Patients

    Seq Age Sex Outcome Treatment
    1