BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EPICENTER¿ SINGLE USER SOFTWARE

    MDR report key: 12965073 · Received December 8, 2021

    Report

    Report Number
    1119779-2021-01928
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 9, 2021
    Report Date
    August 4, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904410070
    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

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY CUSTOMER HAS NOTICED THAT THE BP FOR PUD V6.81 HAS BP FOR IMIPENEM ON ENTEROCOCCUS SPP. IS SET AT 4 INSTEAD OF 8 ON EPICENTER (MATERIAL 441007/SN (B)(6). ). THIS ISSUE IS BEING ADDRESSED UNDER (B)(4). IN AN UPCOMING VERSION OF THE PUD DO TO BE RELEASED THIS QUARTER. THIS IS A CONFIRMED COMPLAINT OF A BD PRODUCT. PER BALTRM-441007-APH REVISION 5, THE FAILURE ASSOCIATED TO THIS COMPLAINT IS A USER INCONVENIENCE WHICH IS A SEVERITY OF S1; REFERENCE ID 6.6. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF NOVEMBER. NO TRENDS INDICATED. DHR REVIEW IS NOT REQUIRED FOR STAND ALONE 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 USER ERROR ON THE BD EPICENTER¿ SINGLE USER SOFTWARE CAUSED THE RESISTANCE BP FOR IMIPENEM ON ENTEROCOCCI TO BE SET AT 4 INSTEAD OF 8. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS NOTICED THAT THE BP FOR PUD V6.81 HAS BP FOR IMIPENEM ON ENTEROCOCCUS SPP. IS SET AT 4 INSTEAD OF 8. EUCAST 2020 SETS R>4 AND ON EPICENTER SHOULD BE >/=8. PUD V6.81 HAS RESISTANCE BP FOR IMIPENEM ON ENTEROCOCCI AT 4 INSTEAD OF 8. INCIDENT HAPPENED DURING USE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT USER ERROR ON THE BD EPICENTER¿ SINGLE USER SOFTWARE CAUSED THE RESISTANCE BP FOR IMIPENEM ON ENTEROCOCCI TO BE SET AT 4 INSTEAD OF 8. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS NOTICED THAT THE BP FOR PUD V6.81 HAS BP FOR IMIPENEM ON ENTEROCOCCUS SPP. IS SET AT 4 INSTEAD OF 8. EUCAST 2020 SETS R>4 AND ON EPICENTER SHOULD BE >/=8. PUD V6.81 HAS RESISTANCE BP FOR IMIPENEM ON ENTEROCOCCI AT 4 INSTEAD OF 8. INCIDENT HAPPENED DURING USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857601 BD EPICENTER¿ SINGLE USER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECTON, DICKINSON & CO. (SPARKS) 441007 NA 00382904410070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown