BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUC 4 OS IMG IOT10/EPI 4.0

    MDR report key: 20722634 · Received November 19, 2024

    Report

    Report Number
    1119779-2024-00901
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    August 23, 2024
    Report Date
    January 7, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER REPORTING EPICENTER (444165/(B)(6)) REPORTING AN ERROR 1009 AND SPECIMEN ACCESSION WAS WRONGLY TAGGED TO ANOTHER PATIENT ID AND NAME (PATIENT A'S ACCESSION TO PATIENT B). DISCOVERED THAT THE CUSTOMER LIS WAS SENDING MESSAGES IN AN INCORRECT ASTM FORMAT. REACHED OUT TO THE LIS VENDOR AND THE ISSUE WAS RESOLVED. THIS IS NOT A CONFIRMED COMPLAINT OF A BD PRODUCT. COMPLAINTS FOR SOFTWARE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF AUGUST. 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

    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 NUC 4 OS IMG IOT10/EPI 4.0, THERE WAS MISASSOCIATION OF AN UNSPECIFIED NUMBER OF SAMPLES. AFTER EPICENTER ENCOUNTERED ERROR 1009, SPECIMEN ACCESSION NUMBERS WERE WRONGLY TAGGED TO THE INCORRECT PATIENT ID AND NAME. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING NUC 4 OS IMG IOT10/EPI 4.0, THERE WAS MIS-ASSOCIATION OF AN UNSPECIFIED NUMBER OF SAMPLES. AFTER EPICENTER ENCOUNTERED ERROR 1009, SPECIMEN ACCESSION NUMBERS WERE WRONGLY TAGGED TO THE INCORRECT PATIENT ID AND NAME. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308466 NUC 4 OS IMG IOT10/EPI 4.0 UNKNOWN MDB BECTON DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown