BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® FT4

    MDR report key: 6344138 · Received February 20, 2017

    Report

    Report Number
    3002769706-2017-00032
    Event Type
    Malfunction
    Date Received
    February 20, 2017
    Date of Event
    January 25, 2017
    Report Date
    July 7, 2017
    Manufacturer
    BIOMERIEUX SA
    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 REPORTED THE OCCURRENCE OF FALSELY UNDERESTIMATED RESULTS IN ASSOCIATION WITH VIDAS® FT4 LOT 1005291190. AN INVESTIGATION WAS PERFORMED. AN ANALYSIS OF CUSTOMER RESULTS HIGHLIGHTED IMPORTANT VARIATIONS OF INTER AND INTRA-BATCH RESULTS IN VIDAS® FT4 : -THE INTRA-LOT ANALYSIS (VIDAS® FT4 LOT 1005291190) SHOW VARIATIONS FROM 3% TO 23% AND A POSSIBLE CHANGE OF INTERPRETATION, -THE INTER-BATCH ANALYSIS (VIDAS® FT4 LOTS 171102-0 AND 171116-0) SHOW VARIATIONS FROM 10% TO 28% AND A POSSIBLE CHANGE OF INTERPRETATION FROM ONE LOT TO ANOTHER LOT. A REVIEW OF QUALITY RECORDS FOR VIDAS® FT4 LOT 1005291190 CONFIRMED IT WAS WITHIN SPECIFICATIONS. THE QUALITY PRODUCT LABORATORY TESTED 5 INTERNAL SAMPLES WITH AN EUTHYROID INTERPRETATION AND OBTAINED THE FOLLOWING RESULTS : (B)(6). ALL SAMPLES WERE WITHIN THE EXPECTED RANGE. A REPEATABILITY TEST WAS PERFORMED WITH FIVE (5) REPETITIONS USING A POOL OF SERUM (BLOOD DONORS SAMPLES) ON VIDAS® FT4 LOT 1005291190 AND OBTAINED THE FOLLOWING VARIABILITY RESULTS : (B)(4) THE QUALITY PRODUCT LABORATORY REPRODUCED THE CUSTOMER'S ANOMALY. AS A CONSEQUENCE, DISTRIBUTION OF VIDAS® FT4 REFERENCE 30459 LOT 1005291190 WAS STOPPED 04APR2017 THROUGH PRODUCT STOP SHIPMENT NUMBER (B)(4). THEN FIELD SAFETY CORRECTIVE ACTION NUMBER (B)(4), INCLUDING A CUSTOMER LETTER, WAS ISSUED 20APR2017. CUSTOMERS WERE ASKED TO DISCONTINUE USE AND DISCARD ANY REMAINING INVENTORY OF THE VIDAS® FT4 REFERENCE 30459 LOT 1005291190, IDENTIFY ANY POSSIBLE FALSE RESULT, ANALYZE THE RELATED RISKS AND DETERMINE APPROPRIATE ACTIONS IF RELEVANT. FURTHER INVESTIGATIONS USING VIDAS® FT4 REFERENCE 30459 LOT 1005291190 WERE PERFORMED TO IDENTIFY THE ROOT CAUSE OF THIS REPRODUCIBILITY ISSUE. THE INVESTIGATION CONCLUDED THAT DUE TO A DIFFERENCE OF SIGNAL OBSERVED BETWEEN THE STRIPS USED IN LOT 1005291190, A PART OF THE TEST DOES NOT PERFORM PROPERLY AND THAT CAN LEAD TO A POSSIBLE INTERPRETATION'S CHANGE DEPENDING ON THE VARIATION IN THE SIGNAL MEASURED. THIS SIGNAL DECREASE SEEMS TO BE DUE TO A PRODUCTION SHUTDOWN LINKED TO CONJUGATE WELL #4. THIS CONJUGATE SOLUTION WAS TESTED, AND NO CONTAMINATION WAS HIGHLIGHTED. THE INVESTIGATIONS CANNOT BE PURSUED FURTHER.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF FALSELY UNDERESTIMATED RESULTS IN ASSOCIATION WITH THE VIDAS® FT4 ASSAY (REF. 30459). WHILE PRODUCT 30459 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES, A SIMILAR PRODUCT (VIDAS® FT4, REF. 30459-01) IS. THE CUSTOMER STATED THE DISCREPANT VIDAS® FT4 RESULT WAS NOT REPORTED TO THE PHYSICIAN; THEREFORE THE DISCREPANT RESULT HAD NO IMPACT ON PATIENT THERAPY, ALTHOUGH RESULTS WERE DELAYED TWO DAYS) DUE TO RETESTING. THE DISCREPANT RESULT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMÉRIEUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126119 VIDAS® FT4 VIDAS® FT4 CEC BIOMERIEUX SA 1005291190

    Patients

    Seq Age Sex Outcome Treatment
    1