BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® HS TROPONIN I

    MDR report key: 6587566 · Received May 24, 2017

    Report

    Report Number
    3002769706-2017-00125
    Event Type
    Malfunction
    Date Received
    May 24, 2017
    Date of Event
    April 12, 2017
    Report Date
    July 28, 2017
    Manufacturer
    BIOMERIEUX, S.A.
    Product Code
    MMI
    PMA / PMN Number
    K063243
    Removal / Correction Number
    FSCA 3360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX FALSELY OVERESTIMATED RESULTS IN ASSOCIATION WITH VIDAS® HS TROPONIN I 60 TESTS. THE CUSTOMER DID NOT SUBMIT A PRODUCT SAMPLE FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE CUSTOMER RESULTS OBTAINED WITH VIDAS TNHS 1005255170 FOR A PATIENT: THE (B)(6), TROPONIN I = 4626NG/L. THE (B)(6), 4356NG/L WITH A NEW SAMPLE. THE (B)(6), 4239 NG/L WITH A NEW SAMPLE. THE PATIENT IS SENT TO THE HOSPITAL ,THE RESULT WAS 4575NG/L THE HOSPITAL TESTED THE SERUM OF (B)(6) AND FOUND: 3.5 NG/L WITH AN OTHER METHOD. ACCORDING TO A WORK LIST SENT BY THE CUSTOMER, THE SAMPLE WAS ALSO TESTED WITH ANOTHER VIDAS TNHS LOT 180302-0 AND THE RESULT WAS HIGH 4912 NG/L. A REVIEW OF QUALITY RECORDS CONFIRMED VIDAS TNHS LOT 1005255170 WAS WITHIN MANUFACTURING SPECIFICATION. A QUALITY STUDY OF 15 BATCHES OF VIDAS TNHS SHOWED LOT 1005255170 WAS IN THE TREND ANALYSIS COMPARED TO THE OTHER BATCHES. THE QUALITY PRODUCT LABORATORY PERFORMED A CALIBRATION AND TESTED SAMPLES FROM THE EFS ON LOT 1005255170. THE RESULTS OF THE CALIBRATION WERE IN ACCORDANCE WITH MLE DATA AND THE RESULTS OF THE EFS SAMPLES WERE NEGATIVE. NO OUTLIERS WERE DETECTED. THE CUSTOMER DID NOT PROVIDE A RETURN SAMPLE, AND WITHOUT THIS SAMPLE THE INVESTIGATION CAN NOT BE CONTINUED. POTENTIAL INTERFERENCES WITH TNHS REAGENTS LEADING TO FALSE POSITIVE RESULTS IN THE FIELD HAVE ALREADY BEEN DESCRIBED THROUGH MANY PUBLICATIONS AND CONCERNED DIFFERENT ASSAYS IN THE MARKET. THE VIDAS TNHS KIT IS AT THE STATE OF THE ART, INDEED FALSE POSITIVE RESULTS CONCERNING SIMILAR INTERFERENCES HAVE BEEN DESCRIBED IN NUMEROUS PUBLICATIONS AND FOUND IN COMPETING TECHNIQUES. AS A REMINDER, IN THE INSTRUCTIONS FOR USE - LIMITATIONS OF THE METHOD SECTION, IT'S WRITTEN THAT "INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SAMPLES CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S CLINICAL HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED." THE VIDAS TNHS LOT 1005255170 IS WITHIN CURRENT ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX FALSELY OVERESTIMATED RESULTS IN ASSOCIATION WITH VIDAS® HS TROPONIN I 60 TESTS (UDI (B)(4)). THE CUSTOMER REPORTED THAT A PATIENT WITHOUT CARDIAC SYMPTOMS HAD A HIGH SENSITIVE TROPONIN TEST VALUE OF 4626 NG/L. THE NEXT DAY THE PHYSICIAN REPACKED THE SAMPLE AND RECEIVED A RESULT OF 4356 NG/L. FIVE DAYS LATER THE RESULT WAS 4239 NG/L. THE PATIENT WAS SENT TO THE HOSPITAL WHERE THE TROPONIN TEST RESULT WAS NORMAL (NEGATIVE). THE CUSTOMER WAS ABLE TO TEST THE HOSPITAL SERUM WHICH GAVE A RESULT OF 4575 NG/L. THE HOSPITAL TESTED THE CUSTOMER SERUM AND THE RESULT WAS 3.5 NG/L. THE CUSTOMER REPORTED THE INCORRECT RESULT WAS REPORTED TO THE PHYSICIAN AND THE IMPACT TO PATIENT TREATMENT IS NOT KNOWN. THE CUSTOMER STATED THERE WAS A ONE DAY DELAY FOR REPORTING AND ADDITIONAL RETESTING OCCURRED WITHIN FIVE DAYS. 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
    370393 VIDAS® HS TROPONIN I VIDAS® HS TROPONIN I MMI BIOMERIEUX, S.A. 1005255170

    Patients

    Seq Age Sex Outcome Treatment
    1