BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUC 4 OS IMG IOT10/EPI 4.0

    MDR report key: 16773343 · Received April 19, 2023

    Report

    Report Number
    1119779-2023-00448
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 21, 2023
    Report Date
    June 1, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE ISSUE BEING REPORTED IS WITH THE EPICENTER SOFTWARE WHICH IS LOADED IN THE NUC PLEASE SEE BELOW FOR EPICENTER SOFTWARE 510K INFORMATION BEING USED: D1: MEDICAL DEVICE BRAND NAME: BD EPICENTER¿ SINGLE USER SOFTWARE. D2A: COMMON DEVICE NAME: CALCULATOR/DATA PROCESSING MODULE. D2B: MEDICAL DEVICE TYPE OR (PROCODE):JQP. D4 MEDICAL DEVICE CATALOG #: 444165. G5. PMA/510K INFO: EXEMPT.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CUSTOMER REPORTED THAT AFTER EPI UPGRADE TO V 7.21Q (444162/SN (B)(6) SYNERCID WAS NOT BLOCKED/SUPPRESSED AS THE DISCONTINUATION CUSTOMER LETTER STATED AND CUSTOMER DID IT MANUALLY. UPON FURTHER INVESTIGATION, THE PANELS USED CONTAINED SYNERCID AND THE RESULTS ON THOSE LOTS OF PANELS SHOULD HAVE BEEN REPORTED AS EXPECTED. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EPICENTER¿ SINGLE USER SOFTWARE UPGRADE WAS NOT BLOCKED AND SYNERCID IS NOT MEANT TO PROVIDE RESULT BUT IT DID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED THAT AFTER EPI UPGRADE TO V 7.21Q SYNERCID WAS NOT BLOCKED/SUPPRESSED AS THE DISCONTINUATION CUSTOMER LETTER STATED AND CUSTOMER DID IT MANUALLY. 1- D-TEST FAILED AND TRANSFERRED CLINDA AS SENSITIVE, GENTAMYCIN, MOXIFLOXACIN AND TETRACYCLINE SHOULD¿VE NOT CROSS TO LIS. 2-GENTAMYCIN AND MOXIFLOXACIN SHOULD¿VE NOT CROSS TO LIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EPICENTER¿ SINGLE USER SOFTWARE UPGRADE WAS NOT BLOCKED AND SYNERCID IS NOT MEANT TO PROVIDE RESULT BUT IT DID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED THAT AFTER EPI UPGRADE TO V 7.21Q SYNERCID WAS NOT BLOCKED/SUPPRESSED AS THE DISCONTINUATION CUSTOMER LETTER STATED AND CUSTOMER DID IT MANUALLY 1- D-TEST FAILED AND TRANSFERRED CLINDA AS SENSITIVE, GENTAMYCIN, MOXIFLOXACIN AND TETRACYCLINE SHOULD¿VE NOT CROSS TO LIS. 2-GENTAMYCIN AND MOXIFLOXACIN SHOULD¿VE NOT CROSS TO LIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601442 NUC 4 OS IMG IOT10/EPI 4.0 CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown