BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS T4 60 TESTS

    MDR report key: 11720344 · Received April 23, 2021

    Report

    Report Number
    8020790-2021-00113
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Report Date
    July 7, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    KLI
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE REPUBLIC OF KOREA REGARDING DISCREPANT RESULTS (SUSPECTED OVERESTIMATED RESULTS) WHEN TESTING A VETERINARY SAMPLE WITH VIDAS® T4 60 TESTS (REFERENCE#: (B)(4), BATCH # 1008521300, EXPIRY DATE: 11JAN2022) IN COMPARISON WITH THE RESULTS OBTAINED ON FT4N AND WITH THE FUSE METHOD. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: CUSTOMER'S MATERIAL NO CUSTOMER'S SAMPLE WAS AVAILABLE TO BE TESTED. QUALITY CONTROL RECORDS THE ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS T4 REF 30404 (LOT 1008521300 / 220111-1) SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. CONTROL CHARTS ANALYSIS THE COMPLAINT LABORATORY ANALYZED THE RESULTS OF FOUR (4) INTERNAL SAMPLES (TARGETS 64.9 - 80.50 - 24.8 AND 158 NMOL / L) ON SEVEN (7) DIFFERENT BATCHES VIDAS T4 REF 30404 INCLUDING CUSTOMER'S LOT (1008521300 / 220111-1). THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATION AND THE CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED BY COMPLAINT LABORATORY THE COMPLAINT LABORATORY TESTED FIVE (5) INTERNAL SAMPLES (3 EUTHYROID, 1 HYPOTHYROID AND 1 HYPERTHYROID), ON RETAIN KIT VIDAS T4 REF 30404 LOT 1008521300 / 220111-1 AND ANOTHER LOT (211012-0 / 1008361520) WITH OTHER RAW MATERIALS. ALL SAMPLE RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS WITH THE TWO LOTS USED. ALL SAMPLE RESULTS HAD SIMILAR VALUES TO THOSE OBSERVED BEFORE THE BATCH RELEASE. THERE WAS NO EVOLUTION OBSERVED OVER TIME OF THE CUSTOMER'S LOT SINCE ITS RELEASE. CONCLUSION ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED WITH THE RETAIN KIT LOT (1008521300 / 220111-1) AND ANOTHER LOT (211012-0 / 1008361520) OF VIDAS T4 REF 30404. WITHOUT THE CONCERNED SAMPLE, FURTHER INVESTIGATION CANNOT BE PURSUED TO EXPLAIN THE RESULTS OBSERVED BY THE CUSTOMER. HOWEVER, THERE ARE TWO HYPOTHESES: THIS DOG HAD A TREATMENT FOR HYPOTHYROID AND IT WAS AN EXCESSIVE DOSE. THIS DOG HAS HAD NO TREATMENT SO ONLY THE FT4 RESULT SHOULD BE CONSIDERED BECAUSE FT4 IS MORE SPECIFIC THAN T4. VIDAS T4 IS NOT 100% CANINE WHICH MEANS THAT IF THE RESULT BETWEEN T4 AND FT4 SHOWS OPPOSITE, THEN ONLY CONSIDER THE FT4 EVEN IF THE DOG DOESN'T HAVE TREATMENT. BASED ON THE INFORMATION MENTIONED ABOVE, VIDAS T4 (LOT 1008521300 / 220111-1) IS MEETING ITS SPECIFICATIONS.

    Description of Event or Problem · 0

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING DISCREPANT RESULTS (SUSPECTED OVERESTIMATED RESULTS) WHEN TESTING A VETERINARY SAMPLE WITH VIDAS® T4 60 TESTS (REFERENCE#: 30404, BATCH # 1008521300, EXPIRY DATE: 11JAN2022) IN COMPARISON WITH THE RESULTS OBTAINED ON FT4N AND WITH THE FUSE METHOD. THE SERUM SAMPLE WAS COLLECTED ON A SEVEN (7) YEAR-OLD DOG AND THE RESULTS WERE THE FOLLOWING: ¿ ON (B)(6) 2021 AT 11:59:T4 RESULT WAS 4.93 UG/DL ¿ ON (B)(6) 2021 AT 17:42:T4 RESULT WAS 5.02 UG/DL ¿ ON (B)(6) 2021 AT 15:40:T4 RESULT WAS 5.2 UG/DL ¿ ON (B)(6) 2021 AT 12:25:FT4N RESULT WAS 0.49 NG/DL ACCORDING TO THE CUSTOMER¿S DOSE RANGES, EUTHYROIDISM IS DEFINED WITH T4 VALUES BETWEEN 1.1653 AND 3.8844 UG/DL: THE THREE T4 RESULTS WERE OVER THE EUTHYROIDISM RANGE GIVEN BY THE CUSTOMER. PER BIOMÉRIEUX ASSESSMENT, THESE ELEVATED RESULTS COULD SUGGEST POTENTIAL HYPERTHYROIDISM. AT THE TIME OF ASSESSMENT, WE DID NOT HAVE THE CUSTOMER¿S RANGE FOR HYPERTHYROIDISM. AS FOR FT4 RESULTS, THE CUSTOMER'S DOSE RANGES SHOW THAT HYPOTHYROIDISM IS CONSIDERED WHEN FT4 VALUES ARE <0.8546 NG/DL WHICH WAS THE CASE. IT WAS ALSO REPORTED THAT AN ALTERNATIVE METHOD WAS TRIED (FUSE) AND THE RESULT WAS 0.85 UG/DL WHICH ALSO INDICATED HYPOTHYROIDISM. THE DOG PRESENTED NO SYMPTOMS AND WAS RECEIVING NO TREATMENT. THE INCORRECT RESULT WAS REPORTED TO THE VETERINARIAN AND THE CUSTOMER CLAIMED A DELAY OF ABOUT FIVE (5) DAYS IN REPORTING RESULTS. A RETEST WAS PERFORMED AND THE RESULT OF T4 WAS 5.33UG/DL AND THE RESULT OF FT4 WAS 0.38NG/DL (4.93 PMOL/L). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT OR DELAYED RESULT LED TO ANY ADVERSE EVENT RELATED TO THE DOG'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE # 30404 IS NOT REGISTERED IN THE US; HOWEVER, THERE IS A US SIMILAR DEVICE PRODUCT REFERENCE # 30404-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615896 VIDAS T4 60 TESTS VIDAS® T4 60 TESTS KLI BIOMERIEUX, SA 1008521300

    Patients

    Seq Age Sex Outcome Treatment
    1