BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TSH ASSAY

    MDR report key: 5041657 · Received August 31, 2015

    Report

    Report Number
    3002769706-2015-00077
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 6, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LYR
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION WAS CONDUCTED. REVIEW OF THE QUALITY PRODUCT LABORATORY BATCH RECORDS INDICATES VIDAS® TSH BATCH 160226-0/1003835280 PASSED ALL PERFORMANCE TESTING; NO ANOMALIES WERE CITED. THIS LOT PERFORMED IN ACCORDANCE WITH SPECIFICATIONS. THE CUSTOMER SUBMITTALS (3) WERE TESTED VIA THE FOLLOWING METHODS: VIDAS® TSH, VIDAS® TSH3, VIDAS® FT4, COBAS TSH/ROCHE. THE RESULTS OF ALL METHODS CONSISTENTLY INDICATE HYPERTHYROÏDISM; THE INCONSISTENT RESULTS OBTAINED BY THE CUSTOMER ARE NOT REPRODUCED/CONFIRMED. THE VIDAS® TSH REF. (B)(4) BATCH 1003835280/160223-0 IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON 06.08.2015 A USA CUSTOMER REPORTED TSH RESULTS AS IMMEASURABLE USING REF. (B)(4), VIDAS TSH 60 TESTS. CUSTOMER RAN SEVERAL OTHER ASSAYS WHICH CAME OUT AS EXPECTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT VIDAS TSH RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. RECURRENCE OF THE EVENT MAY POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575439 VIDAS® TSH ASSAY VIDAS® TSH ASSAY LYR BIOMERIEUX SA 1003835280

    Patients

    Seq Age Sex Outcome Treatment
    1