BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® FT4 ASSAY

    MDR report key: 7596028 · Received June 13, 2018

    Report

    Report Number
    3002769706-2018-00077
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 14, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    CEC
    PMA / PMN Number
    K132058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGES TO SECTION H6: METHOD CODE 11, METHOD CODE 3331 AND METHOD CODE 4102 WERE ADDED. RESULTS CODE WAS UPDATED TO 213. CONCLUSION CODE WAS UPDATED TO 67. UPDATED MANUFACTURER NARRATIVE FOR CLARIFICATION: AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: ANALYSIS OF THE BATCH HISTORY RECORDS : NO ANOMALY RECORDED DURING THE MANUFACTURING AND CONTROL PROCESSES. THE CUSTOMER DID NOT RETURN SAMPLES; THEREFORE, TESTING WAS PERFORMED ON SIX INTERNAL SAMPLES WITH THE IMPACTED LOT AND ANOTHER LOT. THE CUSTOMER'S ANOMALY COULD NOT BE REPRODUCED ON THE SIX INTERNALLY TESTED SAMPLES. THE REAGENT VIDAS® FT4N, BATCH NUMBER 180924-0, WAS WITHIN THE EXPECTED PERFORMANCES OF THE PRODUCT. WITHOUT RETURNED SAMPLES, IT IS NOT POSSIBLE TO INVESTIGATE FURTHER. VIDAS® FT4 RESULT SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER PARAMETER RESULTS (SUCH AS TSH) PATIENT CLINICAL CONTEXT AND HISTORY, AS INDICATED IN THE PACKAGE INSERT, PAGE 1 (VIDAS FT4 REF 30459): "THE VIDAS® FT4 TEST AIDS IN DIAGNOSING THYROID DISORDERS. THE FT4 ASSAY MUST BE USED IN CONJUNCTION WITH OTHER TESTS, SUCH AS TSH, AS WELL AS A CLINICAL EXAMINATION OF THE PATIENT (4)."

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE REAGENT VIDAS® FT4N, AND BATCH NUMBER 180924-0 IS WITHIN THE EXPECTED PERFORMANCES OF THE PRODUCT. THE CUSTOMER'S ANOMALY COULD NOT BE REPRODUCED ON THE SIX (6) SAMPLES TESTED INTERNALLY. WITHOUT RETURNED SAMPLES IT IS NOT POSSIBLE TO INVESTIGATE FURTHER. VIDAS® FT4 RESULT SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER PARAMETER RESULTS (SUCH AS TSH) PATIENT CLINICAL CONTEXT AND HISTORY, AS INDICATED IN THE PACKAGE INSERT, PAGE 1 (VIDAS FT4 REF 30459): "THE VIDAS® FT4 TEST AIDS IN DIAGNOSING THYROID DISORDERS. THE FT4 ASSAY MUST BE USED IN CONJUNCTION WITH OTHER TESTS, SUCH AS TSH, AS WELL AS A CLINICAL EXAMINATION OF THE PATIENT (4)." IT IS NECESSARY TO PERFORM REGULAR INSTRUMENT MAINTENANCE IN ORDER TO ENSURE THE MINI VIDAS®, VIDAS® AND VIDAS 3® ARE FUNCTIONING CORRECTLY AND ENSURE THE QUALITY OF YOUR DAILY RESULTS. THESE PROCEDURES ARE DESCRIBED IN THE MINI VIDAS®, VIDAS® OR VIDAS 3® USER MANUALS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSELY UNDER-ESTIMATED RESULTS FOR TWO PATIENTS IN ASSOCIATION WITH THE VIDAS® FT4 ASSAY (LOT 1002011310) AND A TSH (THYROID) PANEL ON (B)(6) 2018. EACH PATIENT SAMPLE WAS TESTED ON TWO DIFFERENT LOTS OF THE FT4 (FREE THYROXINE) ASSAY. THE CUSTOMER STATED THE CALIBRATIONS WERE CORRECT. THE EUTHYROID REFERENCE RANGE FOR FT4 IS [0.82-1.5] NG/DL. THE RESULTS WERE: PATIENT 1: TSH 1.14 UIU/ML [0.25-5]. FT4 : 0.81 NG/DL (2301 RFV) OTHER LOT. FT4 : 0.14 NG/DL (3227 RFV) LOT 1002011310 - TOO LOW. PATIENT 2: TSH 0.84 UIU/ML [0.25-5]. FT4 : 1.36 NG/DL (1794 RFV) OTHER LOT. FT4 : 0.46 NG/DL (2370 RFV) LOT 1002011310 - TOO LOW. THE CUSTOMER DID NOT REPORT THE RESULTS FOR LOT 1002011310, BUT REPORTED RESULTS FROM A DIFFERENT LOT. THERE WAS NO IMPACT ON THE PATIENTS' TREATMENT AND THERE WAS NO DELAY. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437797 VIDAS® FT4 ASSAY VIDAS® FT4 ASSAY CEC BIOMERIEUX, S.A. 1006011310

    Patients

    Seq Age Sex Outcome Treatment
    1