BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5120A SIMPLERA SYNC 5PK US

    MDR report key: 24934767 · Received April 21, 2026

    Report

    Report Number
    2032227-2026-163411
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 21, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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. 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

    04/13/2026 19:31:05 SENSOR FILAMENT RETRACTION T/S PER DOP114-962DOC VER BE. CUSTOMER REPORTED SENSOR FILAMENT RETRACTING UP THROUGH SENSOR NEEDLE HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585885 SENSOR MMT-5120A SIMPLERA SYNC 5PK US SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown