BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® FT4 ASSAY

    MDR report key: 6725006 · Received July 19, 2017

    Report

    Report Number
    3002769706-2017-00193
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    June 6, 2017
    Report Date
    September 13, 2017
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    CEC
    PMA / PMN Number
    K132058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE SAMPLE WAS NOT RETURNED TO BIOMÉRIEUX BY THE CUSTOMER. A REVIEW OF DEVICE HISTORY RECORD FOR THIS LOT WAS PERFORMED AND NO DISCREPANCY OR ANOMALY WAS OBSERVED DURING THIS REVIEW. THE QUALITY CONTROL DEPARTMENT TESTED FOUR (4) INTERNAL SAMPLES WITH THE RETAIN KIT VIDAS® FT4 FROM LOT 1005451940 / 180111-0 ON THE VIDAS® INSTRUMENT. THE RESULTS OBTAINED FOR THE FOUR (4) SAMPLES WERE WITHIN SPECIFICATION. THE QUALITY PRODUCT DEPARTMENT TESTED CROSS-REAGENT BETWEEN FT4 STRIPS AND TSH AND FT3 SPR®S: WITH THE RETAIN KIT VIDAS® FT4N LOT 1005451940 / 180111-0, ON THE VIDAS® INSTRUMENT, THE LABORATORY TESTED THE C1 AND FOUR (4) INTERNAL SAMPLES OF VIDAS® FT4N FROM THE QUALITY CONTROL DEPARTMENT. THE LABORATORY TESTED STRIPS FT4N WITH TSH AND FT3 SPR®S FROM THE RETAIN KIT, THE RESULTS WERE AS FOLLOWS: TSH LOT G60; RESULT > 100 PMOL / L FOR C1 AND 4 SAMPLES (> 7.77 NG / DL). FT3 LOT G22; RESULT NOT LINKED TO THE CUSTOMER'S ISSUE. QUALITY PRODUCT DEPARTMENT SHOWS THAT A RESULT > 100 PMOL / L OR 7.77 NG / DL CAN BE OBTAINED WHEN WE CROSSED WITH A FT4N STRIP WITH A TSH SPR®. WITH FT3 SPR®, WE DID NOT OBTAIN A RESULT IN ALIGNMENT WITH THE CUSTOMER'S ISSUE. THE ANALYSIS OF CONTROL CARD ON FOUR (4) INTERNAL SAMPLES SHOWS THAT VIDAS® FT4N BATCH 1005451940 / 180111-0 IS WITHIN SPECIFICATION AND SIMILAR TO OTHER BATCHES OF PRODUCT PRODUCED. UNFORTUNATELY, IT WAS IMPOSSIBLE TO IDENTIFY THE ROOT CAUSES OF THE NON-REPRODUCIBLE RESULT OBTAINED BY THE CUSTOMER, BECAUSE THE CUSTOMER DID NOT RETURN A SAMPLE. AS EXPLAINED IN THE PACKAGE INSERT:" VIDAS® FT4 ASSAY RESULTS SHOULD BE INTERPRETED AS PART OF A COMPLETE CLINICAL EVALUATION AND THYROID FUNCTION ASSESSMENT, INCLUDING AT LEAST TSH DETERMINATION". THE LIKELY ROOT CAUSE IS A CROSS BETWEEN USING A FT4N STRIP WITH A TSH SPR®. THE CUSTOMER WILL BE REMINDED OF GOOD LABORATORY PRACTICES. THE VIDAS® FT4N KIT, LOT 1005451940 / 180111-0 IS PERFORMING AS EXPECTED.

    Additional Manufacturer Narrative · 1

    ADDED UDI NUMBER (B)(4) TO THE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF INCONSISTENT RESULTS FOR THE SAME SPECIMEN IN ASSOCIATION WITH THE VIDAS® FT4 ASSAY (REF. 30459). WHILE PRODUCT REFERENCE 30459 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES, A SIMILAR PRODUCT (VIDAS® FT4, REF. 30459-01) IS. ON (B)(6) 2017 A PATIENT SPECIMEN WAS TESTED VIA THE VIDAS® FT4 ASSAY PRODUCING A RESULT >7.77 NG/DL (THE UPPER LIMIT OF THE TEST). A REPEAT TEST WAS PERFORMED LESS THAN 30 MINUTES LATER AND OBTAINED A RESULT OF 1.44 NG/DL. ON (B)(6) 2017 A NEW SPECIMEN WAS TAKEN FROM THE PATIENT AND TESTED VIA ALTERNATE METHOD (MAGLUMI CHEMOLUMINESCENCE); THE RESULT WAS 1.01 NG/DL (EUTHYROIDISM: 0.89 - 1.72 NG/DL) INDICATING THE INITIAL VIDAS® FT4 RESULT WAS OVER-ESTIMATED. THE CHEMOLUMINESCENCE RESULT (1.01 NG/DL) WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER STATED THAT NEITHER VIDAS® FT4 RESULT WAS REPORTED TO THE PHYSICIAN; THEREFORE THE OVER-ESTIMATED RESULT HAD NO IMPACT ON PATIENT THERAPY, ALTHOUGH RESULTS WERE DELAYED ONE - TWO DAYS DUE TO RETESTING. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504581 VIDAS® FT4 ASSAY VIDAS® FT4 ASSAY CEC BIOMÉRIEUX SA 1005602280

    Patients

    Seq Age Sex Outcome Treatment
    1