BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EPICENTER¿ SINGLE USER SOFTWARE

    MDR report key: 18059410 · Received November 2, 2023

    Report

    Report Number
    1119779-2023-01198
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 29, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER INDICATING THAT A SAMPLE IS CONNECTED TO THE WRONG PATIENT ((B)(6)). TROUBLESHOOTING INDICATED THAT THE NEW BOTTLE ATTACHED TO OLD PATIENT. LOGGED IN VIA BOMGAR. MOVED NEW VIAL TO A DUMMY ACCESSION NUMBER, FINALIZED OLD SPECIMEN, CREATED NEW SPECIMEN AND THEN MOVED BOTTLE TO CORRECT ACCESSION. IT IS EXPECTED THAT CUSTOMERS FINALIZE OLDER SPECIMEN TO AVOID THIS POSSIBILITY IN THE FUTURE. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF OCTOBER. 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

    H.3. 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 THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE, THERE WAS 1 INCORRECT PATIENT. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT EPICENTER INCORRECT PATIENT. TROUBLESHOOTING STEPS PERFORMED BY SERVICE: NEW BOTTLE ATTACHED TO OLD PATIENT. LOGGED IN VIA BOMGAR. MOVED NEW VIAL TO A DUMMY ACCESSION NUMBER, FINALIZED OLD SPECIMEN, CREATED NEW SPECIMEN AND THEN MOVED BOTTLE TO CORRECT ACCESSION. REVIEWED/ANSWERED ADVERSE EVENT QUESTIONS, INCLUDING PATIENT IMPACT WITH THE CUSTOMER (IF APPLICABLE) (Y/N): N/A. NO IMPACT ON PATIENT RESULTS. ON FRI OCT 13 18:31:07 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS. INCORRECT PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD EPICENTER¿ SINGLE USER SOFTWARE, THERE WAS 1 INCORRECT PATIENT. THIS IS A REPORT OF ONE OCCURRENCE, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT EPICENTER WAS THE INCORRECT PATIENT. TROUBLESHOOTING STEPS PERFORMED BY SERVICE: NEW BOTTLE ATTACHED TO OLD PATIENT. LOGGED IN VIA BOMGAR. MOVED NEW VIAL TO A DUMMY ACCESSION NUMBER, FINALIZED OLD SPECIMEN, CREATED NEW SPECIMEN AND THEN MOVED BOTTLE TO CORRECT ACCESSION. REVIEWED/ANSWERED ADVERSE EVENT QUESTIONS, INCLUDING PATIENT IMPACT WITH THE CUSTOMER (IF APPLICABLE) (Y/N): N/A. NO IMPACT ON PATIENT RESULTS. ON (B)(6) 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS INCORRECT PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297552 BD EPICENTER¿ SINGLE USER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECTON DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown