BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUC 4 OS IMG IOT10/EPI 4.0

    MDR report key: 16828771 · Received April 28, 2023

    Report

    Report Number
    1119779-2023-00498
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    April 7, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.5 ¿ USE BD EPICENTER¿ SINGLE USER SOFTWARE IN DESCRIPTION.D: MEDICAL DEVICE BRAND NAME: BD EPICENTER¿ SINGLE USER SOFTWARED.3 COMMON DEVICE NAME: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USEMEDICAL DEVICE TYPE: JQPUDI: 00382904410070G: 510K: EXEMPTH.6 INVESTIGATION SUMMARY THE CLIENT RECEIVES AN AEROBIC BLOOD CULTURE FROM 2023 ASSOCIATED WITH A PATIENT FROM 2022, THE PATIENTS ARE DIFFERENT BUT WITH THE SAME ACCESS NUMBER. HE DOESN'T UNDERSTAND WHY THE SYSTEM (444165/ SN JRPN117002N3) RECONNECTS AN ALREADY TARGETED BLOOD CULTURE TO A NEW PATIENT. FIXED ISSUE ON SPECIFIC REPEATED SAMPLE BY FINALIZING THE OLD ONE AND MOVING THE NEW TESTS TO THE NEW SAMPLE. UPON FOLLOWUP, THE CUSTOMER REPORTS 2 MORE PROBLEM SAMPLES AND WAS ALSO SOLVED BY FINALIZING THE OLD ONES AND MOVING THE NEW TESTS TO THE NEW SAMPLES. PERFORMED DEEP DATABASE CLEANUP BY ADDING "OLD22" ENDING TO 2022 SAMPLES TO PREVENT THE SAME SITUATION FROM HAPPENING AGAIN. ADVISED THE CUSTOMER ON HOW TO PREVENT THE ISSUE FROM RECURRING. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL. 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 THE NUC 4 OS IMG IOT10/EPI 4.0 THAT THERE WAS MISASSOCIATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENT RECEIVES AN AEROBIC BLOOD CULTURE FROM 2023 ASSOCIATED WITH A PATIENT FROM 2022, THE PATIENTS ARE DIFFERENT BUT WITH THE SAME ACCESS NUMBER. HE DOESN'T UNDERSTAND WHY THE SYSTEM RECONNECTS AN ALREADY TARGETED BLOOD CULTURE TO A NEW PATIENT. I WOULD LIKE TO AVOID THESE PROBLEMS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335729 NUC 4 OS IMG IOT10/EPI 4.0 NA JQP BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown