BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ESTRADIOL II

    MDR report key: 15944810 · Received December 8, 2022

    Report

    Report Number
    8020790-2022-00111
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Report Date
    January 24, 2023
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    CHP
    PMA / PMN Number
    K955647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ITALY OF POSSIBLE OVERESTIMATED RESULT COMPARED TO ANOTHER METHOD WHEN TESTING WITH VIDAS® ESTRADIOL II (B)(4) TESTS (REF. 30431, LOT #1009577970, EXPIRY DATE 22-AUG-2023) WITH A PATIENT SAMPLE. 1) CUSTOMER MATERIAL ********************* 1 TUBE OF SAMPLE WITH 300 L OF SERUM. 2) INVESTIGATION OUTCOMES *************************************** 2-1) COMPLAINT ANALYSIS ------------------------------------------- THE COMPLAINT ANALYSIS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. 2-2) 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 19.5 / 156 / 426 AND 3721 PG/ML (DISTRIBUTED ALL ALONG THE MEASUREMENT RANGE). - ON EIGHT (8) LOTS OF VIDAS® ESTRADIOL II REF.30431 INCLUDING THE LOT 1009577970 MENTIONED BY THE CUSTOMER. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS AND THE LOT 1009577970 WAS IN THE TREND COMPARED TO THE OTHER LOTS. **TEST ON INTERNAL SAMPLES** ~~~~~~~~~~~~~~~~~~~~~~~ THE COMPLAINTS LABORATORY TESTED: - 4 INTERNAL SAMPLES WITH THE FOLLOWING TARGETS 19.5 / 156 / 426 AND 3721 PG/ML (DISTRIBUTED ALL ALONG THE MEASUREMENT RANGE). - ON VIDAS® ESTRADIOL II LOT 1009577970 (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 LOT RELEASE. NO EVOLUTION WAS OBSERVED OVER TIME OF THESE SAMPLES ACTIVITY. **TESTS ON PATIENT¿S SAMPLE** ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ OUR COMPLAINTS LABORATORY TESTED THE SAMPLE RETURNED BY THE CUSTOMER ON 2 LOTS OF VIDAS® ESTRADIOL II (RETAIN KITS): THE LOT USED BY THE CUSTOMER (LOT 1009577970) AND ANOTHER LOT WITH THE SAME RAW MATERIALS AS THE PREVIOUS LOT USED BY THE CUSTOMER (LOT 1009176990). - ON THE LOT 1009577970, THE SAMPLE GAVE A RESULT OF 8331.68 PG/ML (394 RFV) AFTER A DILUTION 1:4 IN A MALE SERUM AND A RESULT >1200 PG/ML (255 RFV) AFTER DILUTION 1:4 IN A SALINE SOLUTION. - ON THE LOT 1009176990, THE UNDILUTED SAMPLE GAVE A RESULT >3000 PG/ML (161 RFV) AND A RESULT OF 7976.9 PG/ML (387 RFV) AFTER A DILUTION 1:4 IN A MALE SERUM. UNFORTUNATELY, THERE WAS NOT ENOUGH SAMPLE TO PERFORM A DILUTION 1:2 OR TO TEST USING ANOTHER METHOD. 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 1009577970. THE COMPLAINTS LABORATORY DID NOT REPRODUCED THE RESULTS > 1200 PG/ML WHEN TESTING THE SAMPLE AT DILUTION 1:4 IN A MALE SERUM. THIS RESULT WAS ONLY OBSERVED WHEN TESTING THE SAMPLE DILUTED 1:4 IN A SALINE SOLUTION. THE UNDILUTED SAMPLE GAVE A RESULT > 3000 PG/ML WITH A LOT MANUFACTURED WITH THE SAME RAW MATERIALS AS A LOT PREVIOUSLY USED BY THE CUSTOMER (SIMILAR RESULT AS CUSTOMER). THE SAMPLE GAVE RESULTS NOT SIGNIFICANTLY DIFFERENT WITH 2 LOTS OF VIDAS® ESTRADIOL II (CONCERNED LOT AND LOT MANUFACTURED WITH SAME RAW MATERIALS AS THE LOT PREVIOUSLY USED BY THE CUSTOMER). THE RESULTS OBSERVED ON THE UNDILUTED SAMPLE AND ON THE SAMPLE AFTER DILUTION 1:4 IN A MALE SERUM ARE CONSISTENT AND DO NOT HIGHLIGHT AN ANALYTICAL INTERFERENCE. THE RESULT > 1200 PG/ML WAS NEVER REPRODUCED ON THE DILUTED SAMPLE EXCEPT WITH A SALINE SOLUTION USED AS DILUENT: ALL THE RESULTS OBSERVED WERE CONSISTENT AND OVER 3000 PG/ML. IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS ESTRADIOL II REF.30431 AT SECTION 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 ». UNFORTUNATELY, IT WAS NOT POSSIBLE TO HAVE INFORMATION ABOUT THE TREATMENT TAKEN BY THE PATIENT. BUT, 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 REF.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.¿ UNFORTUNATELY, THERE IS NO MORE SAMPLE, SO WE CANNOT PURSUE FURTHER THE INVESTIGATION (E.G NO POSSIBILITY TO TEST USING ANOTHER METHOD) AND 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 WHEN PERFORMING THE DILUTION. ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF VIDAS® ESTRADIOL II REF.30431 LOT 1009577970.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER IN ITALY NOTIFIED BIOMÉRIEUX OF POSSIBLE OVERESTIMATED RESULT COMPARED TO ANOTHER METHOD WHEN TESTING WITH VIDAS® ESTRADIOL II 60 TESTS (REF. 30431, LOT #: 1009577970, EXPIRY DATE 22-AUG-2023) WITH A PATIENT SAMPLE. THE PATIENT IS A WOMAN UNDER HORMONAL STIMULATION, FOLLOWING ASSISTED FERTILIZATION. THE SAMPLE WAS TESTED DILUTED 1:4 ON (B)(6) 2022 AND GAVE A RESULT > 12000 PG/ML WITH A SIGNAL OF 215 RFV. A SECOND SAMPLE WAS TESTED DILUTED 1:2 ON (B)(6) 2022 AND GAVE A RESULT > 6000 PG/ML WITH A SIGNAL OF 229 RFV. THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE RESULT WAS 2200 PG/ML. THE ALTERNATIVE METHOD IS UNKNOWN AT THIS TIME OF THE ASSESSMENT. THE CUSTOMER USED ANOTHER LOT (LOT NUMBER UNKNOWN AT THIS TIME OF THE ASSESSMENT) OF : VIDAS® ESTRADIOL II 60 TESTS (REF. 30431 AND THE RESULT WAS 2800 PG/ML. THE POSSIBLE WRONG RESULT WAS TRANSMITTED TO THE DOCTOR. THE CUSTOMER STATED THERE WAS NO DELAY IN REPORTING RESULTS AND THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE REFERENCED ISSUE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE 30431 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30431-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250073 VIDAS® ESTRADIOL II VIDAS® ESTRADIOL II CHP BIOMÉRIEUX SA 1009577970

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown