BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® ESTRADIOL II (E2II)

    MDR report key: 16234466 · Received January 24, 2023

    Report

    Report Number
    8020790-2023-00008
    Event Type
    Injury
    Date Received
    January 24, 2023
    Report Date
    February 17, 2023
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER IN SPAIN OF POTENTIAL OVER-ESTIMATED RESULTS WITH PATIENT SAMPLES LEADING TO INCORRECT TREATMENT WHEN USING VIDAS® ESTRADIOL II (E2II) REFERENCE: 30431 (LOT: 1009667250, EXPIRY: 28-SEP-2023). 2) INVESTIGATION OUTCOMES. 2-1) COMPLAINT ANALYSIS. THE ANALYSIS OF COMPLAINTS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. 2-2) QUALITY CONTROL RECORDS. THERE IS NEITHER CAPA NOR NON-CONFORMITY LINKED TO THIS ISSUE ON THIS VIDAS ASSAY. 2-3) 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 30 / 38.2/ 219 AND 278 PG/ML. ON EIGHT (8) BATCHES OF VIDAS ESTRADIOL II REF.30431 INCLUDING THE LOT: 1009667250 MENTIONED BY THE CUSTOMER. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS AND THE LOT: 1009667250 IS IN THE TREND COMPARED TO THE OTHER LOTS. TEST ON INTERNAL SAMPLES: THE COMPLAINTS LABORATORY TESTED: THREE (3) INTERNAL SAMPLES WITH THE FOLLOWING TARGETS 38.18 / 219 AND 267.52 PG/ML ON VIDAS ESTRADIOL II LOT: 1009667250/230928 (RETAIN KIT OF CUSTOMER¿S LOT). THE RESULTS COMPLIED WITH THE SPECIFICATIONS AND THE RESULTS WERE NOT SIGNIFICANTLY DIFFERENT COMPARED TO THOSE OBSERVED BEFORE THE BATCH RELEASE. THERE WAS NO EVOLUTION OVER TIME OF THE SAMPLES ACTIVITY. CONCLUSION: THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE ISSUE REPORTED BY THE CUSTOMER (RESULT TOO HIGH) WHEN TESTING INTERNAL SAMPLES ON VIDAS ESTRADIOL II LOT: 1009667250. IT WAS NOT POSSIBLE TO HAVE INFORMATION ABOUT THE TREATMENT TAKEN BY THE PATIENT. IT IS IMPORTANT, WHEN INTERPRETING ESTRADIOL RESULTS, TO TAKE INTO ACCOUNT THE INFORMATION RELATING THE THERAPEUTIC TREATMENT ESPECIALLY IF IT IS BASED ON ESTROGEN SUBSTANCES. IT IS WRITTEN IN THE PACKAGE INSERT OF VIDAS ESTRADIOL II REFERENCE: 30431: ¿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.¿ WITHOUT THE IMPACTED SAMPLE, FURTHER INVESTIGATION COULD NOT BE PURSUED TO EXPLAIN THE RESULTS OBSERVED BY THE CUSTOMER. THE RESULTS OBSERVED BY THE CUSTOMER CAN BE DUE FOR A PART TO THE TREATMENT OF THE PATIENT AND/OR TO AN ISSUE WITH PRE-ANALYTICAL STEPS. ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF VIDAS ESTRADIOL II REFERENCE: 30431, LOT: 1009667250.

    Description of Event or Problem · 0

    PRODUCT DESCRIPTION: 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. ISSUE DESCRIPTION: ON (B)(6) 2023, A CUSTOMER FROM SPAIN NOTIFIED BIOMÉRIEUX OF POTENTIAL OVER-ESTIMATED RESULTS WITH PATIENT SAMPLES LEADING TO INCORRECT TREATMENT WHEN USING VIDAS® ESTRADIOL II (E2II) REFERENCE 30431 (LOT 1009667250, EXPIRY 28-SEP-2023). RESULT VALUES WERE REPORTED TO BE 200-300 PG/ML, HOWEVER WHEN SENDING TO A REFERENCE LABORATORY FOR CONFIRMATION THE VALUES WERE 40 PG/ML. THE REFERENCE LABORATORY ALSO USES VIDAS METHOD AS WELL. THE RECENT QCV PERFORMED ON THE INSTRUMENT DID NOT INDICATE ANY ISSUES. THE CUSTOMER REPORTED THAT THE INCORRECT TREATMENT WAS PROVIDED TO THE PATIENT. THE TREATMENT WAS STOPPED AFTER THE REFERENCE LABORATORY RESULTS WERE RELEASED. NOTE - PRODUCT REFERENCE 30431 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, THERE IS A SIMILAR DEVICE, PRODUCT REFERENCE 30431-01. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347483 VIDAS® ESTRADIOL II (E2II) VIDAS® ESTRADIOL II (E2II) CHP BIOMÉRIEUX SA 1009667250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown