BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TSH

    MDR report key: 8017067 · Received October 29, 2018

    Report

    Report Number
    3002769706-2018-00226
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Report Date
    December 27, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    KLI
    PMA / PMN Number
    K926393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER HAD NOTIFIED BIOMÉRIEUX ABOUT FALSE LOW VIDAS® TSH RESULTS FROM ONE HEALTHY PATIENT DURING A CONTROL EXAM. IN JULY, THE FIRST RESULT WAS <0.05MUI/L WITH LOT VIDAS TSH 1006127340 / 181117-0. THE PATIENT WAS TESTED IN ANOTHER LAB WITH ANOTHER TECHNIQUE . THE RESULT WAS BETWEEN NORMAL VALUES. THE PATIENT WAS RETESTED WITH VIDAS TSH IN SEP-2018 AND RESULTS AGAIN WERE <0.05MUI/L WITH LOT 1006277930 / 190129-0. IN OCTOBER, THE CUSTOMER TESTED THE SAMPLE AGAIN (THE RESULT WAS <0.05MUI/L) WITH LOT VIDAS TSH 1006277930 / 190129-0 AND PERFORMED A DILUTION AND THE RESULT WAS 0.18MUI/L (THE RESULT INCREASED AFTER THE DILUTION). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. INVESTIGATION RESULTS REGARDING VIDAS TSH LOT 1006277930 / 190129-0: BATCH HISTORY RECORDS AND TREND ANALYSIS: THERE IS NO OTHER COMPLAINT ON THE BATCH VIDAS TSH LOT 1006277930 / 190129-0 FOR THE SAME ISSUE . THERE IS NO CAPA, NOR NON-CONFORMITY LINKED WITH THE CUSTOMER 'S COMPLAINT. THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. STUDY OF INTERNAL SAMPLES CONTROL CHARTS: THIS ANALYSIS WAS CARRIED OUT : ON FIVE (5) INTERNAL SERA WITH DIFFERENT CONCENTRATIONS (TARGET :0.05 MUI/L, 0.49 MUI/L, 0.50 MUI/L, 4.27 MUI/L 25.6 MUI/L). ON FIVE (5) BATCHES INCLUDING THE BATCH MENTIONED BY THE CUSTOMER, VIDAS TSH LOT 1006277930 / 190129-0 . ALL THE RESULTS WERE WITHIN SPECIFICATIONS. VIDAS TSH LOT 1006277930 / 190129-0 IS WITHIN THE TREND COMPARED TO THE OTHER BATCHES. TESTS PERFORMED: ON INTERNAL SAMPLES: THE LABORATORY TESTED FIVE (5) INTERNAL SERA ON VIDAS TSH LOT 1006277930 / 190129-0: HYPER 9 TARGET 0.05 MUI/L RANGE [ </= 0.16 MUI/L ] RESULT = <0.05 MUI/L. TSH40 TARGET 0.49 MUI/L RANGE [0.32-0.66 MUI/L] RESULT =0.50 MUI/L. TSH21 TARGET 0.50 MUI/L RANGE [0.33-0.67 MUI/L] RESULT =0.47 MUI/L. TSH22 TARGET 4.27 MUI/L RANGE [3.58-4.96 MUI/L] RESULT =4.41 MUI/L. HYPO 18 TARGET 25.60 MUI/L RANGE [21.83- 29.37MUI/L] RESULT =27.08 MUI/L. THE RESULTS ARE WITHIN THE EXPECTED VALUES, AND THERE IS NO EVOLUTION SINCE THE BATCH RELEASE. TESTS PERFORMED BY THE CUSTOMER: THE CUSTOMER TESTED THE PATIENT'S SAMPLES ON TWO DIFFERENT LOTS VIDAS TSH, AND THE RESULTS WERE < 0.05 MUI/L. THIS LOW RESULT IS NOT DUE TO A PARTICULAR LOT OF VIDAS TSH. THE CUSTOMER PERFORMED A DILUTION (ON THE SECOND LOT), AND THE RESULT INCREASE AFTER THE DILUTION. THIS BEHAVIOR COULD BE DUE TO AN INTERFERENCE PRESENT IN THE PATIENT'S SAMPLES. UNFORTUNATELY WITHOUT THE RETURN OF THE SAMPLE , IT WAS NOT POSSIBLE TO IDENTIFY THIS POTENTIAL INTERFERENCE. CONCLUSION: ACCORDING TO THE INVESTIGATION RESULTS, THE PERFORMANCE OF THE LOT VIDAS TSH 1006277930 / 190129-0 WAS WITHIN EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE LOW RESULT FOR ONE HEALTHY PATIENT DURING A CONTROL EXAM, WITH TWO DIFFERENT LOTS OF THE VIDAS® TSH ASSAY. THE CUSTOMER STATED THE TSH RESULT FROM LOT 1006127340 WAS <0.05. THE RESULT WAS REPORTED TO THE ENDOCRINOLOGIST, AND THEY DID NOT AGREE WITH THE RESULT, SO THE PATIENT WAS SENT TO ANOTHER LAB FOR REPEAT ANALYSIS. THE REPEAT RESULT WAS WITHIN NORMAL VALUES. THE CUSTOMER THEN OBTAINED ANOTHER SAMPLE FROM THE PATIENT AND REPEATED THE TSH ASSAY WITH LOT 1006277930, AND THE RESULT WAS <0.05. THE CUSTOMER REPORTED THAT THE PATIENT'S T4 AND TOTAL T4 VALUES WERE NORMAL. THE CUSTOMER STATED THAT PATIENT TREATMENT WAS NOT IMPACTED AND THERE WAS NO DELAY. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED 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
    856359 VIDAS® TSH VIDAS® TSH KLI BIOMERIEUX SA 1006277930

    Patients

    Seq Age Sex Outcome Treatment
    1