BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS FSH 60 TESTS

    MDR report key: 10402455 · Received August 13, 2020

    Report

    Report Number
    8020790-2020-00075
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Report Date
    September 21, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    CGJ
    PMA / PMN Number
    K921746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN GERMANY REGARDING OUT-OF-RANGE-LOW (OORL) RESULTS FOR AN EQA SAMPLE (INSTAND SAMPLES 21 AND 22) IN ASSOCIATION WITH THE VIDAS FSH ASSAY (REF. (B)(4), LOT 1007652290). SAMPLE 21 PEER GROUP 3.51 UI / L ACCEPTABLE RANGE [2.77-4.25] UI / L. CUSTOMER'S RESULT 2.65 UI / L OUT OF THE ACCEPTABLE RANGE. SAMPLE 22 PEER GROUP 70.5 UI / L ACCEPTABLE RANGE [55.7-85.3] UI / L. CUSTOMER'S RESULT 55.1 UI / L OUT OF THE ACCEPTABLE RANGE. A BIOMÉRIEUX INVESTIGATION WAS CONDUCTED; HOWEVER, THE CUSTOMER DID NOT SUBMIT ANY SAMPLE FOR TESTING. EVALUATION OF MANUFACTURING BATCH RECORDS INDICATED NO ANOMALY DURING THE STAGES OF MANUFACTURE, CONTROL AND PACKAGING. ANALYSIS OF SEVERAL INTERNAL SERUM SERA ON SEVEN (7) LOTS OF VIDAS FSH REF. (B)(4), INCLUDING CUSTOMER LOT, INDICATED THE LOT WAS IN SPECIFICATION AND IN THE TREND WITH THE OTHER LOTS. INVESTIGATIONAL TESTING OF THE IMPLICATED LOT WITH FOUR (4) INTERNAL SAMPLES AND TWO (2) SAMPLES OF PROBIOQUAL SHOWED ALL RESULTS OBTAINED COMPLY WITH THE EXPECTED AND TARGETED STANDARDS. THE LOT HAS NOT DRIFTED SINCE ITS RELEASE. THE ANOMALY WAS NOT REPRODUCED. THE ISSUE REPORTED BY THE CUSTOMER (LOW RESULTS FOR SAMPLES 21 AND 22 EXTERNAL QUALITY CONTROL INSTAND) WAS NOT REPRODUCED BY COMPLAINTS LABORATORY WITH SAMPLE AVAILABLE IN THE LABORATORY. WITHOUT THE CUSTOMER'S RETURN SAMPLE, FURTHER INVESTIGATION AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE. THE INVESTIGATION CONCLUDED THE KIT VIDAS FSH REF. (B)(4), BATCH 1007652290 / 200922-0 IS WITHIN THE EXPECTED PERFORMANCE. THERE ARE NO OTHER COMPLAINTS FOR A SIMILAR ISSUE ON VIDAS FSH REF (B)(4), LOT 1007652290 / 200922-0.SEE H10.

    Description of Event or Problem · 1

    NOTE: REFERENCE (B)(4) IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE (B)(4). A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING AN OUT RANGE RESULT FOR AN EXTERNAL INSTAND QUALITY CONTROL SAMPLE IN ASSOCIATION WITH THE VIDAS® FSH 60 TESTS (REF (B)(4), BATCH 1007652290). THE CUSTOMER STATED OUT OF RANGE LOW RESULT WAS OBTAINED WHEN TESTING INSTAND QUALITY CONTROL SAMPLE 21. CUSTOMER RESULT AND SPECIFIED RANGE ARE LISTED BELOW. SAMPLE 21, CUSTOMER RESULT: 2.65 IU/L, SPECIFIED RANGE: 2.77 - 4.25 IU/I. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL SAMPLE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865352 VIDAS FSH 60 TESTS VIDAS® FSH 60 TESTS CGJ BIOMERIEUX SA 1007652290

    Patients

    Seq Age Sex Outcome Treatment
    1