BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUC 4 OS IMG IOT10/EPI 4.0

    MDR report key: 16074996 · Received December 29, 2022

    Report

    Report Number
    1119779-2022-01555
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 18, 2022
    Report Date
    January 30, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: DATA SHOWS THAT THERE ARE TESTS THAT ARE STILL PENDING AND ARE NEVER FED INTO THE INSTRUMENT. THE VIALS ARE THEREFORE ALWAYS PENDING AND WHEN A SEQUENCE NUMBER ASSOCIATED WITH ONE OF THESE OLD FILES IS SCANNED, IT IS FOUND ASSOCIATED WITH THE OLD FILE AND NOT WITH THE NEW ONE. THE HELP FILE CONTAINS INFORMATION ABOUT PRUNING THE DATABASE AND IS ENABLED BY DEFAULT. IN ADDITION, COMMUNICATION REGARDING DATABASE PRUNING OCCURS AT THE TIME OF INSTALLATION TO ENSURE THAT THE CUSTOMER IS AWARE OF THE IMPACT OF LEAVING OLD DATA IN THE SYSTEM. IN THIS CASE, IT APPEARS THAT THE OLD DATA WAS NEVER PURGED AS RECOMMENDED. THIS CAUSED THE DATA TO BE UNINTENTIONALLY MIS-ASSOCIATED TO AN OLD FILE. THIS ISSUE WAS DISCOVERED AND CORRECTED BEFORE ANY RESULTS WERE SENT FOR THE PATIENT OR TO A PRESCRIBER. THEREFORE, CONFIGURED EPICENTER (444165/SN (B)(6)) PURGE TO PURGE PENDING TESTS OLDER THAN 60 DAYS AND ALSO PURGE SAMPLES WITH NO TESTS OR ISOLATES. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF DECEMBER. NO TRENDS INDICATED. DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED FOR STANDALONE SOFTWARE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER EMAIL: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EPICENTER¿ SINGLE USER SOFTWARE ARE SEEING ASSOCIATION ERROR'S ON VIAL WITH REDUNDANT SEQUENCE NUMBER'S. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVE DUPLICATE SEQUENCE NUMBERS ON THE VIALS BETWEEN 2019 AND 2022. NO IMPACT ON THE PATIENT FILE BECAUSE THE 2019 FILES ARE VALIDATED AND FINALIZED, BUT AT THE LEVEL OF EPICENTER IT DOES NOT MATCH THE NUMBER OF THE LAST PATIENT. WE NOTICED THIS THROUGH POSITIVE FILES THAT WERE NOT PUBLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EPICENTER¿ SINGLE USER SOFTWARE ARE SEEING ASSOCIATION ERROR'S ON VIAL WITH REDUNDANT SEQUENCE NUMBER'S. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVE DUPLICATE SEQUENCE NUMBERS ON THE VIALS BETWEEN 2019 AND 2022. NO IMPACT ON THE PATIENT FILE BECAUSE THE 2019 FILES ARE VALIDATED AND FINALIZED, BUT AT THE LEVEL OF EPICENTER IT DOES NOT MATCH THE NUMBER OF THE LAST PATIENT. WE NOTICED THIS THROUGH POSITIVE FILES THAT WERE NOT PUBLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454995 NUC 4 OS IMG IOT10/EPI 4.0 NA JQP BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown