BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDAS® TROPONIN I ULTRA

    MDR report key: 7037219 · Received November 16, 2017

    Report

    Report Number
    3002769706-2017-00369
    Event Type
    Injury
    Date Received
    November 16, 2017
    Report Date
    April 24, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    MMI
    PMA / PMN Number
    K063243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS WHEN USING THE PRODUCT: VIDAS® TROPONIN I ULTRA (REF. 30448) - LOT 1005708360 - 180510-0. THE CUSTOMER REPORTED OBTAINING THE DISCREPANT RESULTS ON NINE DIFFERENT PATIENTS WHEN RETESTING THE PATIENTS' SAMPLES, AND THERE WAS A MINIMUM OF A THREE-HOUR DELAY IN REPORTING RESULTS. AN INVESTIGATION WAS PERFORMED. THE CUSTOMER PERFORMED A QCV AND CALIBRATION; RESULTS CONFORMED WITH SPECIFICATIONS. THE LOCAL FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE. THE FSE IDENTIFIED AN ISSUE WITH THE OPTICAL CALIBRATION, AND TOOK ACTION TO RESOLVE THE ISSUE AND CONFIRM PROPER SYSTEM OPERATION. BIOMÉRIEUX INVESTIGATION OF THE VIDAS® TROPONIN I ULTRA (REF. 30448) - LOT 1005708360 - 180510-0, SHOWED THAT RESULTS OBTAINED WERE WITHIN THE EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBTAINED DURING THE CONTROL PERFORMED BEFORE BATCH RELEASE. THERE WAS NO DRIFT OF THE VIDAS TROPONIN I ULTRA REFERENCE 30448 LOT 1005708360 / 180510-0 SINCE ITS RELEASE. AS IT WAS NOT POSSIBLE TO GET CUSTOMER'S SAMPLES, NO FURTHER INVESTIGATION CAN BE PERFORMED TO CONFIRM THE CUSTOMER RESULTS OR IDENTIFY ROOT CAUSE. NO MORE COMPLAINTS WERE RECORDED FROM THE CUSTOMER AFTER FSE INTERVENTION (THE CUSTOMER STATED THAT CURRENT TESTING RESULTS ARE CONSISTENT WITH HIS PATIENT POPULATION). AS DESCRIBED IN THE PACKAGE INSERT, ANY CARDIAC TROPONIN I VALUES LOWER THAN THE REFERENCE VALUE (0.11 UG/L), COMBINED WITH A NEGATIVE ECG AND CHEST PAIN LASTING LESS THAN 6 HOURS, MUST BE CONFIRMED BY A SECOND SPECIMEN 6 HOURS LATER, IN ORDER TO RULE OUT THE DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION (AMI).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS WHEN USING THE PRODUCT: VIDAS® TROPONIN I ULTRA (REF. 30448) - LOT 1005708360 - (B)(4). THE CUSTOMER STATED THAT THEY RUN EACH OF THEIR TROPONIN I TESTS IN DUPLICATE. THE CUSTOMER REPORTED OBTAINING THE DISCREPANT RESULTS ON NINE DIFFERENT PATIENTS WHEN RETESTING THE PATIENTS' SAMPLES. THE CUSTOMER REPORTED THAT THERE WAS A MINIMUM OF A THREE-HOUR DELAY IN REPORTING RESULTS. PATIENT 1: RESULT 1 WAS 0.04 UG/L. RESULT 2 (RETEST RESULT) WAS <0.01 UG/L. TROPONIN I OF 0.04 UG/L WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. HIGH SENSITIVITY TROPONIN T RESULTED AS 55 NG/ML AT THE HOSPITAL PER THE CUSTOMER. PATIENT 2: RESULT 1 WAS <0.01 UG/L. RESULTS 2 WAS 0.02 UG/L. TROPONIN I OF <0.01 UG/L WAS REPORTED. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT FOR THIS PATIENT. PATIENT 3: RESULT 1 WAS 0.04 UG/L. RESULT 2 AND RESULT 3 WERE <0.01 UG/L. TROPONIN I OF <0.01 UG/L WAS REPORTED. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT FOR THIS PATIENT. PATIENT 4: THIS PATIENT HAD 2 SAMPLES COLLECTED. FOR THE PATIENT'S FIRST SAMPLE, RESULT 1 WAS 0.04 UG/L. RESULT 2 AND 3 WERE <0.01 UG/L. FOR THE PATIENT'S SECOND SAMPLE, RESULT 1 WAS 0.24 UG/L. NO REPEAT TESTING WAS DONE ON THAT SAMPLE. TROPONIN I RESULT OF 0.24 UG/L WAS REPORTED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. HIGH SENSITIVITY TROPONIN T RESULTED AS "CRITICAL HIGH" AT THE HOSPITAL PER THE CUSTOMER. PATIENT 5: RESULT 1 WAS 0.04 UG/L. RESULT 2 WAS <0.01 UG/L. TROPONIN I OF <0.01 UG/L WAS REPORTED. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT FOR THIS PATIENT. PATIENT 6: THIS PATIENT HAD 2 SAMPLES COLLECTED. FOR THE PATIENT'S FIRST SAMPLE, RESULT 1 WAS 0.02 UG/L. FOR THE PATIENT'S SECOND SAMPLE, RESULT 1 WAS <0.01 UG/L. NO FURTHER RESULTS PROVIDED BY THE CUSTOMER. THIS PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHOLECYSTECTOMY. THERE IS NO INDICATION FROM THE CUSTOMER THAT THE DISCREPANT RESULT LED TO THE HOSPITALIZATION OR HAD ANY IMPACT ON THE PATIENT OR LED TO AN ADVERSE EVENT RELATED TO THIS PATIENT'S STATE OF HEALTH. PATIENT 7: THIS PATIENT HAD 2 SAMPLES COLLECTED. FOR THE PATIENT'S FIRST SAMPLE, RESULT 1 WAS 0.04 UG/L. FOR THE PATIENT'S SECOND SAMPLE, RESULT 1 WAS <0.01 UG/L. NO FURTHER RESULTS PROVIDED BY THE CUSTOMER. THIS PATIENT WAS TRANSFERRED TO THE HOSPITAL. HIGH SENSITIVITY TROPONIN T RESULTED AS WITHIN NORMAL RANGE TWICE AT THE HOSPITAL, AND THE PATIENT WAS DISCHARGED PER THE CUSTOMER. THIS PATIENT WAS UNNECESSARILY TRANSFERRED TO THE HOSPITAL DUE TO THE DISCREPANT RESULT. PATIENT 8: RESULT 1 WAS 0.04 UG/L. RESULT 2 WAS <0.01 UG/L. SAMPLE WAS CONFIRMED AS <0.01 UG/L BY OUTSIDE LAB. TROPONIN I OF <0.01 UG/L WAS REPORTED. THERE IS NO INDICATION FROM THE CUSTOMER THAT THE DISCREPANT RESULT HAD ANY IMPACT ON THE PATIENT OR LED TO ANY ADVERSE EVENT RELATED TO THIS PATIENT'S STATE OF HEALTH. PATIENT 9: RESULT 1 WAS <0.01 UG/L. RESULT 2 WAS 0.04 UG/L. SAMPLE WAS CONFIRMED AS <0.01 UG/L BY OUTSIDE LAB. TROPONIN I OF <0.01 UG/L WAS REPORTED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR TONGUE EDEMA. THERE IS NO INDICATION FROM THE CUSTOMER THAT THE DISCREPANT RESULT LED TO THE HOSPITALIZATION OR HAD ANY IMPACT ON THE PATIENT OR LED TO AN ADVERSE EVENT RELATED TO THIS PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818477 VIDAS® TROPONIN I ULTRA VIDAS® TROPONIN I ULTRA MMI BIOMERIEUX, SA 1005708360

    Patients

    Seq Age Sex Outcome Treatment
    1