BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS TSH

    MDR report key: 11032502 · Received December 17, 2020

    Report

    Report Number
    8020790-2020-00140
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Report Date
    March 8, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JLW
    UDI-DI
    03573026156886
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BIOMERIEUX CONDUCTED AN INTERNAL INVESTIGATION IN RESPONSE TO A CUSTOMER COMPLAINT OF FALSELY UNDERESTIMATED RESULTS FOR TWO SEPARATE PATIENTS IN ASSOCIATION WITH THE VIDAS® TSH 60 TESTS (REF 30400-01, BATCH 1007944800). THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, OR PACKAGING PROCESSES. THERE WERE NO CAPA OR NONCONFORMITIES LINKED TO THE CUSTOMER'S COMPLAINT. A STUDY ON SIX (6) INTERNAL SERA CONTROL CHARTS ON SEVEN (7) VIDAS TSH BATCHES, INCLUDING THE LOT OF THE CUSTOMER¿S (VIDAS® TSH LOT 1007944800/ 210224-0) WAS PERFORMED. ALL OF THE RESULTS WERE WITHIN SPECIFICATIONS. VIDAS® TSH 1007944790 / 210224-0 WAS IN TREND COMPARED TO THE OTHER BATCHES. BIOMERIEUX REQUESTED THE CUSTOMER TO RETURN THEIR SAMPLES; HOWEVER, THE SAMPLE WAS NOT AVAILABLE. ACCORDING TO THE ANALYSIS OF THE CONTROL CHARTS, AND RESULTS OBTAINED ON THE INTERNAL AND BIORAD SAMPLES, THE PERFORMANCE OF VIDAS® TSH LOT 1007944800/ 210224-0 IS WITHIN THE EXPECTED SPECIFICATIONS. THE INVESTIGATION DID NOT REPRODUCE THE UNDERESTIMATED TSH VALUES OBTAINED BY THE CUSTOMER. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED FOR VIDAS® TSH LOT 1007944800. THE INVESTIGATION DATA SUPPORTS THAT VIDAS® TSH LOT 1007944800/ 210224-0 IS FUNCTIONING AS INTENDED. REFER TO SECTION H10.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX THAT THEY HAVE OBSERVED FALSELY LOW RESULTS FOR A PATIENT'S SAMPLE IN ASSOCIATION WITH THE VIDAS® TSH 60 TESTS (REF.# (B)(4), LOT 1007944800) COMPARED TO RESULTS OBTAINED BY AN EXTERNAL LABORATORY. THE CUSTOMER STATED THAT THEY HAD TESTED A PATIENT FOR TSH ON THEIR VIDAS, THE RESULTS WERE AS FOLLOWS: PATIENT 2: VIDAS RESULT = 0.29 (UNITS NOT REPORTED). REPEAT ANALYSIS WITH THE VIDAS TSH OBTAINED THE SAME RESULTS. THE SAMPLE WAS THEN SENT TO AN EXTERNAL LABORATORY FOR REFERENCE TESTING AS THE CUSTOMER INDICATED THAT THE VIDAS RESULTS DID NOT MATCH THE LAST TIME THE TSH WAS RAN FOR THE PATIENT. THE EXTERNAL LABORATORY RESULTS WERE AS FOLLOWS: PATIENT 2: LABCORP RESULT = 3.30 (UNITS NOT REPORTED). THE CUSTOMER WAS UNSURE WHICH TEST METHOD WAS USED BY THE EXTERNAL LABORATORY. THE CUSTOMER REPORTED THAT NO INCORRECT RESULTS WERE REPORTED TO THE TREATING PHYSICIAN, THERE WAS NO DELAY IN REPORTING RESULTS, AND THIS EVENT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495018 VIDAS TSH VIDAS® TSH JLW BIOMERIEUX SA 30400-01 1007944800 03573026156886

    Patients

    Seq Age Sex Outcome Treatment
    1