BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® FT4 ASSAY

    MDR report key: 6788890 · Received August 11, 2017

    Report

    Report Number
    3002769706-2017-00245
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Report Date
    October 12, 2017
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    CEC
    PMA / PMN Number
    K132058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX DISCREPANT FT4 RESULTS IN ASSOCIATION WITH THE VIDAS® FT4 ASSAY. THE RESULTS WERE NOT REPEATABLE AND DID NOT CORRELATE WITH THE CLINICAL STATUS OF THE PATIENT. INITIAL TEST: VIDAS® FT4 LOT 180321-0: 45,78 PMOL/L. REPEAT TEST: VIDAS® FT4 - 15,91 PMOL/L. A BIOMÉRIEUX INVESTIGATION WAS PERFORMED. BIOMÉRIEUX TESTED FIVE (5) INTERNAL SAMPLES ON SIX (6) DIFFERENT BATCHES. RESULTS OBTAINED FOR INTERNAL SAMPLES ON THE LOT 1005602280/180321-0: FT40028- 12.36 PMOL/L : RANGE : 12.1 PMOL/L [7.74-16.5]. FT40030- 37.60 PMOL/L : RANGE : 36.3 PMOL/L [23.2-49.4]. FT40039- 2.8 PMOL/L : RANGE : 2.21 PMOL/L [0.88-3.54]. FT40023- 57.64 PMOL/L : RANGE : 59.4 PMOL/L [38-80.8]. FT40032- 38.15 PMOL/L : RANGE: 28.56PMOL/L [18.28-38.84]. THE ANALYSIS OF THE CONTROL CARD ON THE FIVE (5) INTERNAL SAMPLES SHOWED THAT VIDAS® FT4 LOT 1005602280/ 180321-0 IS IN TREND WITH THE OTHER BATCHES. BIOMÉRIEUX TESTED THE FIVE (5) INTERNAL SAMPLES WITH THE RETAIN KIT VIDAS® FT4 LOT 1005602280/180321-0: FT40028- 11.38 PMOL/L : RANGE : 12.1 PMOL/L [7.74-16.5]. FT40030- 36.48 PMOL/L : RANGE : 36.3 PMOL/L [23.2-49.4]. FT40039- 2.17 PMOL/L : RANGE : 2.21 PMOL/L [0.88-3.54]. FT40023- 59.39 PMOL/L : RANGE : 59.4 PMOL/L [38-80.8]. FT40032- 37.5 PMOL/L : RANGE: 28.56 PMOL/L [18.28-38.84]. THE RESULTS WERE IN ACCORDANCE WITH THE EXPECTED SPECIFICATIONS. BIOMÉRIEUX REALIZED A REPEATABILITY TEST WITH AN INTERNAL SERA (10 REPEAT), AND CONFIRMED, THERE IS NO PROBLEM WITH THE REPEATABILITY ON THE RETAIN KIT: CV 2.08%. WITHOUT ANY RETURN OF THE PATIENT SAMPLE, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. PER THE RESULTS OF THE INTERNAL INVESTIGATION, THE VIDAS® FT4 LOT 1005602280/180321-0 PERFORMANCE IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX DISCREPANT FT4 RESULTS IN ASSOCIATION WITH THE VIDAS® FT4 ASSAY. THE CUSTOMER REPORTED THEY WERE NOT ABLE TO REPEAT THE RESULT FOR FT4. THE PATIENT WAS TESTED WITH A THYROID PANEL INCLUDING TSH, FT4 AND FT3 ASSAYS. THE RESULTS WERE: TSH - 9,32 UIU/ML. FT4 - 45,78 PMOL/L. FT3 - 5,30 PMOL/L. THE RESULTS WERE GIVEN TO BOTH THE PATIENT AND PHYSICIAN. THE PHYSICIAN DID NOT ACCEPT THE FT4 RESULT AS THE RESULT DID NOT CORRELATE TO THE CLINICAL STATUS OF PATIENT. THE SAME SAMPLE WAS RETESTED AND THE RESULTS WERE: TSH - 9,41 UIU/ML. FT4 - 15,91 PMOL/L. FT3 - 5,39 PMOL/L. THE CUSTOMER REPORTED THAT THE INCORRECT RESULT WAS REPORTED TO A PHYSICIAN WITHOUT A DELAY. THE PATIENT TREATMENT WAS NOT IMPACTED AS THE PHYSICIAN ASKED FOR RETESTING. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE CUSTOMER MENTIONED THAT FAILURE OF THE SPR (SOLID PHASE RECEPTACLE) POSITION IN THE SECTION WAS EXCLUDED, AS ANOTHER SAMPLE WAS TESTED IN THIS POSITION WITH SIMILAR RESULTS. THE INITIAL SAMPLE WAS TESTED WITH FT4 AND FT3 IN THE SAME SECTION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569086 VIDAS® FT4 ASSAY VIDAS® FT4 ASSAY CEC BIOMERIEUX, S.A. 1005602280

    Patients

    Seq Age Sex Outcome Treatment
    1