BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUC 4 OS IMG IOT10/EPI 4.0

    MDR report key: 16390676 · Received February 16, 2023

    Report

    Report Number
    1119779-2023-00150
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 24, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CUSTOMER REPORTING THAT A NUMBER OF BLOOD CULTURES THAT WE HAVE BOOKED INTO THE LIMS CORRECTLY BUT HAVE BEEN ASSOCIATED INCORRECTLY TO ANOTHER PATIENT ON EPICENTER (444165/SN (B)(6)), AUTOMATICALLY BY THE SYSTEM. USING THEIR LIS LOG FILES TO INVESTIGATE, IT APPEARS THAT THE LAB IS NOW USING 2 NUMBERS: 5-DIGIT FOR YORK, AND 6-DIGIT FOR SCARBOROUGH. IT APPEARS THAT THE LIS IS ONLY SENDING 5-DIGIT NUMBERS WHICH MAY BE CREATING AN ISSUE IN EPICENTER IF THE ACCESSION NUMBER ALREADY EXISTS. HAVE ASKED CUSTOMER TO LIAISE WITH THE LUS VENDOR TO SEND THE FULL ACCESSION NUMBER IN THE ORDER MESSAGE TO RESOLVE THE ISSUE. UPON FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE INTERFACE HAS ONLY EVER SENT 5-DIGIT NUMBERS AND AS THEY HAVE ONLY RECENTLY STARTED PROCESSING SCARBOROUGH BC'S THIS IS THE FIRST TIME THE ISSUE HAS APPEARED. THERE IS AN OPEN TICKET FROM 2020 WITH THE VENDOR TO RESOLVE THE ISSUE WITH THE ACCESSION NUMBER. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF FEBRUARY. 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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE NUC 4 OS IMG IOT10/EPI 4.0 THAT THERE WAS MISASSOCIATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A NUMBER OF BLOOD CULTURES THAT WE HAVE BOOKED INTO THE LIMS CORRECTLY BUT HAVE BEEN ASSOCIATED INCORRECTLY TO ANOTHER PATIENT ON EPICENTER, AUTOMATICALLY BY THE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE NUC 4 OS IMG IOT10/EPI 4.0 THAT THERE WAS MISASSOCIATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A NUMBER OF BLOOD CULTURES THAT WE HAVE BOOKED INTO THE LIMS CORRECTLY BUT HAVE BEEN ASSOCIATED INCORRECTLY TO ANOTHER PATIENT ON EPICENTER, AUTOMATICALLY BY THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359291 NUC 4 OS IMG IOT10/EPI 4.0 NA JQP BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown