BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMITTER MMT-7841ZW GST5G OUS

    MDR report key: 19317880 · Received May 15, 2024

    Report

    Report Number
    2032227-2024-169753
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 15, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED NO COMMUNICATION BETWEEN THE INSULIN PUMP AND TRANSMITTER. THE CUSTOMER REPORTED NO ADVERSE EVENTS. THE EVENT INVOLVED PRODUCT(S) MMT-7841ZW. A CUSTOMER REPORTED A LOSS OF COMMUNICATION BETWEEN THE TRANSMITTER AND THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. A PRODUCT RETURN WAS REQUESTED FOR MMT-7841ZW. THE CUSTOMER DECLINED TO RETURN OR IS UNABLE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520036 TRANSMITTER MMT-7841ZW GST5G OUS SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE PQF MEDTRONIC MINIMED MMT-7841ZW 1132059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown