BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 19321232 · Received May 15, 2024

    Report

    Report Number
    8020790-2024-00004
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN (B)(6) REGARDING AN OVERESTIMATED RESULT WHEN TESTING A PATIENT'S SAMPLE WITH VIDAS ESTRADIOL II 60 TESTS (REF. (B)(4), LOT 1010172300, EXPIRY DATE 16-JUL-2024) COMPARED TO ANOTHER METHOD (ROCHE). IN THE COMPLAINT IT WAS INDICATED THAT ISSUE COULD BE RELATED TO PRE-ANALYTICAL PROBLEM. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: CUSTOMER MATERIAL: NO SAMPLE WAS AVAILABLE FOR RETURN. INVESTIGATION OUTCOMES: COMPLAINT ANALYSIS: THE ANALYSIS OF COMPLAINTS RECORDED AGAINST THIS LOT DID NOT REVEAL ANY QUALITY ISSUE FOR THIS LOT OR ANY SYSTEMIC QUALITY ISSUE. QUALITY CONTROL RECORDS: THERE IS NO CAPA, QUALITY EVENT OR NON-CONFORMITY LINKED TO THIS ISSUE ON THIS VIDAS ASSAY. ANALYSIS AND TESTS CONDUCTED BY COMPLAINTS LABORATORY: CONTROL CHART ANALYSIS: THIS ANALYSIS WAS CARRIED OUT: ON FOUR (4) INTERNAL SAMPLES WITH A RESPECTIVE TARGET AT 82.1 / 221/467 AND 1406 PG/ML. - ON (B)(4) BATCHES OF VIDAS ESTRADIOL II REF.(B)(4) INCLUDING THE LOT 1010172300 MENTIONED BY THE CUSTOMER. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS AND THE LOT 1010172300 IS IN THE TREND COMPARED TO THE OTHER LOTS. TEST ON INTERNAL SAMPLES: THE COMPLAINTS LABORATORY TESTED: - (B)(4) INTERNAL SAMPLES WITH THE FOLLOWING TARGETS 467 PG/ML; 221 PG/ML; 84.56 PG/ML). - ON VIDAS ESTRADIOL II LOT 1010172300 (RETAIN KIT OF CUSTOMER¿S LOT). THE RESULTS COMPLY WITH THE SPECIFICATIONS AND THE RESULTS ARE NOT SIGNIFICANTLY DIFFERENT COMPARED TO THOSE OBSERVED BEFORE THE BATCH RELEASE. NO EVOLUTION WAS NOTICED OVER TIME OF THESE SAMPLES ACTIVITY. EEQ REPORT ANALYSIS: AN ANALYSIS OF EEQ REPORTS FROM (B)(4) SUPPLIER, CARRIED OUT ON (B)(4)) SAMPLES BETWEEN THE VIDAS AND ROCHE TECHNIQUES, DID NOT REVEAL ANY BEHAVIOR SIMILAR TO THE CUSTOMER'S RESULTS. CONCLUSION: THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE ISSUE REPORTED BY THE CUSTOMER WHEN TESTING INTERNAL SAMPLES ON VIDAS ESTRADIOL II LOT 1010172300. ALL THE RESULTS WERE COMPLIANT WITH EXPECTATIONS. IT IS WRITTEN IN THE PACKAGE INSERT OF VIDAS ESTRADIOL II REF.(B)(4): 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. INTERPRETATION OF TEST RESULTS SHOULD BE MADE TAKING INTO CONSIDERATION THE PATIENT'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED. - TO FINISH, IT IS ALSO IMPORTANT TO REMIND TO THE CUSTOMER THAT HE MUST PERFORM THE REQUIRED MAINTENANCES (USER MAINTENANCE AND PREVENTIVE MAINTENANCE) IN ORDER TO MAINTAIN INSTRUMENT PERFORMANCES. INSTRUMENT MAINTENANCE REMINDER: IT IS NECESSARY TO PERFORM REGULAR INSTRUMENT MAINTENANCE IN ORDER TO ENSURE THE MINI VIDAS®, VIDAS® AND VIDAS 3® ARE FUNCTIONING CORRECTLY AND ENSURE THE QUALITY OF YOUR DAILY RESULTS. THESE PROCEDURES ARE DESCRIBED IN THE MINI VIDAS®, VIDAS® OR VIDAS 3® USER MANUALS. ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF VIDAS ESTRADIOL II REF.(B)(4) LOT 1010172300.

    Description of Event or Problem · 0

    INTENDED USE. VIDAS® ESTRADIOL II (E2II) IS AN AUTOMATED QUANTITATIVE TEST FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS FOR THE QUANTITATIVE MEASUREMENT OF TOTAL 17 -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. RESULTS AND INTERPRETATION. SAMPLES WITH ESTRADIOL CONCENTRATIONS GREATER THAN 3,000 PG/ML MUST BE RETESTED AFTER MANUAL DILUTION 1/2 IN A SPECIMEN COLLECTED FROM A MALE PATIENT. 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. INTERPRETATION OF TEST RESULTS SHOULD BE MADE TAKING INTO CONSIDERATION THE PATIENT'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED. ISSUE DESCRIPTION ON 22-APR-2024, A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX OF OBSERVING AN OVERESTIMATED RESULT WHEN TESTING A PATIENT'S SAMPLE WITH VIDAS ESTRADIOL II 60 TESTS (REF. 30431, LOT 1010172300, EXPIRY DATE 16-JUL-2024) COMPARED TO ANOTHER METHOD. THE PATIENT'S CLINICAL CONTEXT AND REASON FOR TESTING WERE NOT KNOWN AT THE TIME OF THIS ASSESSMENT. (B)(6) 2024 11:48 AM, MINI VIDAS: - 451.95 PG/ML. THIS RESULT WAS PRECEDED BY A VALID CALIBRATION PERFORMED ON (B)(6) 2024. (B)(6) 2024, ELECTROCHEMILUMINESCENCE AT ANOTHER LABORATORY: - 64.0 PG/ML (INDICATES NON-PREGNANT FOLLICULAR PHASE). THERE WAS NO DELAY IN REPORTING PATIENT RESULTS SINCE THE CUSTOMER OUTSOURCES SAMPLE TESTING TO PREVENT DELAY. A BIOMÉRIEUX FIELD APPLICATION SPECIALIST VISITED THE CUSTOMER'S SITE AND RAN 2 ADDITIONNAL SAMPLES ON VIDAS AND ANOTHER METHOD (NOT CLEAR WHICH METHOD). IT WAS STATED THAT THE DIFFERENCE IN E2 RESULTS WAS NEGLIGIBLE AND THAT A PRE-ANALYTICAL ISSUE IS SUSPECTED. NO FURTHER DETAILS WERE AVAILABLE ABOUT THE PRE-ANALYSTICAL STEPS, SO A USER ERROR COULD NOT BE CONFIRMED AT THE TIME OF THIS ASSESSMENT. IT IS STATED THAT NO WRONG RESULT WAS REPORTED TO THE PHYSICIAN, AND THAT THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT AS A CONSEQUENCE FO THIS ISSUE. THE PRODUCT, VIDAS® ESTRADIOL II (E2II) REFERENCE 30431, IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, A SIMILAR PRODUCT, VIDAS® ESTRADIOL II (E2II) REFERENCE 30431-01 IS MARKETED IN THE UNITED STATES. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469358 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMÉRIEUX SA 1010172300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown