BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE

    MDR report key: 12393600 · Received August 31, 2021

    Report

    Report Number
    3006543086-2021-00002
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    May 1, 2021
    Report Date
    August 31, 2021
    Manufacturer
    NORMAND-INFO S.A.S.U.
    Product Code
    JQP
    UDI-DI
    13700962600655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EXAMINED THE INSTRUMENT AND OBSERVED A FACTOR WAS ENTERED INTO THE DXI INSTRUMENT FOR FT4. THE RESULT WAS TRANSMITTED TO REMISOL, WHERE BOTH RESULTS (UNMODIFIED AND MODIFIED) ARE TRANSMITTED TO THE LABORATORY INFORMATION SYSTEM (LIS) WITH THE SAME LIS CODE. THE FSE ADDED A RULE TO THE RESULT UPLOAD TO HOST TRIGGER. IF BOTH TESTS HAVE RESULTS, THEN THE UNMODIFIED RESULT WILL BE SENT TO THE LIS. THE CUSTOMER PERFORMED A VALIDATION TESTS ON THE RULE WITH A TEST PATIENT AND OBSERVED ONLY MODIFIED RESULT SENT TO HOST. THE DXI ANALYZER DID NOT GENERATE ERRONEOUS RESULTS, AND THE ISSUE WAS RESOLVED. THERE WAS NO FURTHER INFORMATION PROVIDED RELATED TO THE ADJUSTMENT OF MEDICATION. THERE WAS NO REPORT OF IMPACT TO THE PATIENTS AS A RESULT OF THIS EVENT. PT INFO: INFORMATION NOT PROVIDED BY CUSTOMER. (B)(6). (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED INCORRECT FREE THYROXINE 4 (FT4) PATIENT RESULTS WERE INTERMITTENTLY RECEIVED BY REMISOL FROM (B)(6) 2021 TO (B)(6) 2021. THE ERRONEOUS RESULTS WERE RELEASED FROM THE LABORATORY. SEVERAL PATIENTS WERE PRESCRIBED WITH MEDICATION ADJUSTMENT BASED ON THE LOW FT4 RESULTS. THE CUSTOMER DID NOT SPECIFY THE NUMBER OF PATIENTS THAT WERE PRESCRIBED WITH MEDICATION ADJUSTMENT. THERE WAS NO REPORT OF IMPACT TO THE PATIENT RESULTED FROM THE MEDICATION ADJUSTMENT. THE CUSTOMER PROVIDED EXAMPLES OF THE ORIGINAL RESULT AND THE CORRECT RESULT. PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292724 REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP NORMAND-INFO S.A.S.U. REMISOL ADVANCE ACTIVATION CODE WITH USB DONGLE - SERVER 13700962600655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other