BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EPICENTER¿ SINGLE USER SOFTWARE

    MDR report key: 20412164 · Received October 9, 2024

    Report

    Report Number
    1119779-2024-00746
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 10, 2024
    Report Date
    January 23, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904439729
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER REPORTING AN ISSUE IS REGARDING THE PUD VERSION 7.41 WHICH HAS THE RESISTANCE BREAKPOINTS FOR S. AUREUS AND OTHER COAG.NEGATIVE STAPHYLOCOCCI >/=2, WHILST ON THE EUCAST2024 DOCUMENT IS R>2. THIS MEANS THAT IN THE EPICENTER (443972/G6MY646007FV) BREAKPOINT TABLE IN PUD 7.41 WE SHOULD HAVE R >/=4. IN THE EUCAST 2023 DOCUMENT, THE CIP BREAKPOINT FOR STAPH AUREUS AND STAPH COAG- WAS NO SUSCEPTIBLE BREAKPOINT AND A RESISTANT OF >1 (IN THE PUD WE SET THE S <= 1 AND THE R >= 2 WITH AN ASSOCIATED RULE (985) THAT CHANGES ANY RESULT THAT IS AN S (SUSCEPTIBLE) TO I (INTERMEDIATE). IN THE EUCAST 2024 DOCUMENT, THE CIP BREAKPOINT FOR STAPH AUREUS AND STAPH COAG- WAS UPDATED TO NO SUSCEPTIBLE OR INTERMEDIATE BREAKPOINT AND A RESISTANT OF >2. THE PUD V7.41 RELEASE NOTES STATE THAT THE BREAKPOINT WAS NOT UPDATED DUE TO A PENDING REVIEW. THE CUSTOMER IS ABLE TO CUSTOMIZE THE BREAKPOINT IF DESIRED AND UPDATE PER THE EUCAST DOCUMENT. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF SEPTEMBER. 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.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY NAME: (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 WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE THERE WAS ONE FALSE RESULT DUE TO A MISTAKEN BREAKPOINT AFTER THE PUD UPDATE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE THERE WAS ONE FALSE RESULT DUE TO A MISTAKEN BREAKPOINT AFTER THE PUD UPDATE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790470 BD EPICENTER¿ SINGLE USER SOFTWARE CALCULATOR/DATA PROCESSING MODULE JQP BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382904439729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown