BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMTR MMT-7811NA GST3C LOCKOUT

    MDR report key: 14785442 · Received June 23, 2022

    Report

    Report Number
    2032227-2022-226964
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    June 5, 2022
    Report Date
    June 29, 2022
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTS: TRANSMITTER NOT COMMUNICATING ANOMALY. TRANSMITTER RECEIVED AND PLACED UNIT UNDER MICROSCOPE AND FOUND PHYSICAL DAMAGE TO COW CATCHER AND CONNECTOR PINS. IN CONCLUSION, UNABLE TO PERFORM FUNCTIONAL TEST OR VERIFY R/F TEST DUE TO PHYSICAL DAMAGE. THE CUSTOMER COMPLAINT OF COMMUNICATION ANOMALY COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    UNIT RECEIVED AND PLACED UNIT UNDER MICROSCOPE AND FOUND PHYSICAL DAMAGE TO COW CATCHER AND CONNECTOR PINS. IN CONCLUSION, UNABLE TO PERFORM FUNCTIONAL TEST OR VERIFY R/F TEST DUE TO PHYSICAL DAMAGE. THE CUSTOMER COMPLAINT OF COMMUNICATION ANOMALY COULD NOT BE CONFIRMED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS LOSS OF COMMUNICATION BETWEEN INSULIN PUMP AND TRANSMITTER. CUSTOMER STATED THAT THE CONNECTOR BRIDGE OR PINS WERE NOT DAMAGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED, THE CUSTOMER WILL DISCONTINUE THE USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273692 XMTR MMT-7811NA GST3C LOCKOUT ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7811NA 1046848

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female