BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    BD EPICENTER¿ SINGLE USER SOFTWARE

    MDR report key: 22002304 · Received May 12, 2025

    Report

    Report Number
    1119779-2025-00382
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    November 26, 2024
    Report Date
    June 9, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382902520467
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER INDICATING: WHEN I PULLED THE BOTTLE, THE NEGATIVE INFORMATION CAME OUT. THE BOTTLE WAS REMOVED FROM THE FX AND THEN REINSERTED. THE BLOOD CULTURE RESULT WAS POSITIVE, BUT THE MDMS (252046/ (B)(6)) COMMENT SHOWED IT AS NEGATIVE. UNABLE TO GET ADDITIONAL INFORMATION ON THIS ISSUE THEREFORE UNABLE TO DETERMINE THE ROOT CAUSE. NOTES DO INDICATE THAT THE ISSUE REPORTED WAS RESOLVED. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF NOVEMBER. 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 WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE, A POSITIVE BLOOD CULTURE BOTTLE REPORTED AS NEGATIVE WHEN REMOVED FROM THE INSTRUMENT. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825875 BD EPICENTER¿ SINGLE USER SOFTWARE CALCULATOR/DATA PROCESSING MODULE JQP BECTON DICKINSON & CO. (SPARKS) 00382902520467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown