BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS FT4 60 TEST

    MDR report key: 12167741 · Received July 14, 2021

    Report

    Report Number
    8020790-2021-00163
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Report Date
    October 18, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    KLI
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CUSTOMER COMPLAINT WAS ORIGINALLY REGISTERED AGAINST VIDAS® T4 (REF. 30404). REFERENCE 30404 IS NOT REGISTERED IN THE US; HOWEVER, THERE IS A US SIMILAR DEVICE PRODUCT REFERENCE 30404-01. THEREFORE, BASED ON THE RISK OF OBTAINING AN UNDERESTIMATED RESULT, THE EVENT WAS CONSIDERED A REPORTABLE MALFUNCTION. AFTER FURTHER TROUBLESHOOTING WITH THE CUSTOMER, IT WAS CONFIRMED THAT THE ACTUAL PRODUCT INVOLVED IN THIS EVENT IS VIDAS FT4, REFERENCE 30459. THIS PRODUCT, VIDAS FT4 (REFERENCE 30459), IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. THERE IS NO SIMILAR DEVICE CURRENTLY MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. THEREFORE, THIS EVENT WOULD NOT BE CONSIDERED AS REPORTABLE IN THE UNITED STATES. AN INVESTIGATION WAS INITIATED. IT WAS COMPLETED FOR THE CORRECT PRODUCT REFERENCE THAT WAS INDICATED IN THIS EVENT: VIDAS FT4, REFERENCE 30459, LOT 1008278560. INVESTIGATION: REVIEW OF DEVICE HISTORY RECORDS FOR THE LOT IN QUESTION (1008278560) SHOWED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING, CONTROL, AND PACKAGING PROCESSES. CONTROL CHART ANALYSIS WAS PERFORMED FOR THREE INTERNAL SAMPLES ON SEVEN LOTS OF VIDAS®FT4 (REF. 30459), INCLUDING THE CUSTOMER¿S LOT: THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS AND THE CUSTOMER¿S LOT RESULTS ARE CONSISTENT WITH THE OTHER LOTS. THE COMPLAINT LABORATORY TESTED THREE INTERNAL SAMPLES (SAME AS ABOVE, TARGET 14.21, 12.72 AND 6.28 PMOL / L) ON RETAIN KIT VIDAS FT4 REF. 30459 CUSTOMER'S LOT 1008278560. ALL SAMPLES RESULTS ARE WITHIN THEIR EXPECTED SPECIFICATIONS WITH CUSTOMER'S LOT AND DID NOT SHOW ANY RESULT DRIFT FOLLOWING BATCH RELEASE. THE PACKAGE INSERT FOR PRODUCT REFERENCE 30459 DOCUMENTS THE FOLLOWING: RANGE OF EXPECTED VALUES: ¿AS A GUIDELINE, 95% OF THE VALUES CORRESPONDING TO 623 ADULTS WHO MEET THE SELECTION CRITERIA FOR ESTABLISHING EUTHYROID STATUS ARE WITHIN THE RANGE: 10.6 - 19.4 PMOL / L. IT IS RECOMMENDED THAT EACH LABORATORY ESTABLISHES ITS OWN REFERENCE VALUES FROM A RIGOROUSLY SELECTED POPULATION (8).¿ STUDIES PERFORMED USING VIDAS® FT4 GAVE THE FOLLOWING RESULTS: ¿MEASUREMENT RANGE THE MEASUREMENT RANGE OF THE VIDAS® FT4 REAGENT IS FROM 1 TO 100 PMOL / L. THE LIMIT OF QUANTITATION (LOQ) IS THE LOWEST CONCENTRATION OF FREE T4 THAT CAN BE QUANTIFIED WITH A LEVEL OF ACCEPTABLE ACCURACY AND PRECISION. LOQ = 1.11 PMOL / L. THE STUDY WAS PERFORMED AS RECOMMENDED BY THE CLSI DOCUMENT EP17-A. CONCLUSION: ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED ON THE RETAIN KIT FROM THE CUSTOMER¿S LOT. UNFORTUNATELY, WITHOUT THE CONCERNED SAMPLE, FURTHER INVESTIGATION CANNOT BE PURSUED. BASED ON THE INFORMATION MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS FT4 REF. 30459, LOT 1008278560.

    Description of Event or Problem · 1

    ON 15-JUN-2021, A CUSTOMER FROM (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING RESULTS BELOW THE DETECTION LIMIT (UNDERESTIMATED) WHEN TESTING A PATIENT SAMPLE WITH THE VIDAS® T4 60 TESTS ASSAY (REF. 30404, LOT # UNKNOWN, EXPIRY UNKNOWN). THE CUSTOMER REPORTED THAT THIS RESULT DID NOT COINCIDE WITH THE CLINICAL PRESENTATION OF THE PATIENT. THE TEST WAS REPEATED WITH ANOTHER METHOD AND WAS REPORTED TO BE NORMAL. THE ALTERNATIVE METHOD TEST WAS NOT SPECIFIED BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE # (B)(4)IS NOT REGISTERED IN THE US; HOWEVER, THERE IS A US SIMILAR DEVICE PRODUCT REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066712 VIDAS FT4 60 TEST VIDAS® FT4 60 TEST KLI BIOMERIEUX SA 1008278560

    Patients

    Seq Age Sex Outcome Treatment
    1