BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EPICENTER¿ SINGLE USER SOFTWARE

    MDR report key: 20351350 · Received October 2, 2024

    Report

    Report Number
    1119779-2024-00712
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 3, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904441654
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING THE BD EPICENTER¿ SINGLE USER SOFTWARE, THE RULE FIRED IMPROPERLY FOR PSEUDOMONAS AERUGINOSA ISOLATES. NO ADDITIONAL INFORMATION WAS RECEIVED. D1. BRAND NAME: BD EPICENTER¿ SINGLE USER SOFTWARE. D2. COMMON DEVICE NAME: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE. D2B. MEDICAL DEVICE TYPE: JQP. D4. MEDICAL DEVICE CATALOG #: 444165. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G4. PMA/510(K)#: NA. IMDRF ANNEX A GRID: A090804 - FALSE POSITIVE RESULT (1227). H4. DEVICE MANUFACTURE DATE: 28-MAY-2021.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED BY THE CUSTOMER THAT RULE 1826 IS FIRING IMPROPERLY FOR PSEUDOMONAS AERUGINOSA ISOLATES (444165/JRPN0320008B). THIS IS BEING ADDRESSED FOR THE UPCOMING V7.51 PUD RELEASE. THIS IS 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

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020321, K040099, AND K131331. H3. 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 WHILE USING THE BD EPICENTER¿ SINGLE USER SOFTWARE, THE RULE FIRED IMPROPERLY FOR PSEUDOMONAS AERUGINOSA ISOLATES. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD EPICENTER¿ SINGLE USER SOFTWARE, THE RULE FIRED IMPROPERLY FOR PSEUDOMONAS AERUGINOSA ISOLATES. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM A PATIENT ISOLATE (PSEUDOMONAS) WAS REPORTED AS CARBAPENEMASE POSITIVE. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020417 BD EPICENTER¿ SINGLE USER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECTON DICKINSON & CO. (SPARKS) 00382904441654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown