BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-5120A SIMPLERA SYNC 5PK US

    MDR report key: 24889064 · Received April 15, 2026

    Report

    Report Number
    2032227-2026-160586
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 15, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW OF THE EVENT SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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.

    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. 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

    UPDATED SUMMARY: CUSTOMER HAD NOT ALLEGED PACKAGING MISSHAPED OR NOT SEALED PROPERLY. SO, THE EVENT SUBMITTED UNDER REGULATORY REPORT NUMBER 2032227-2026-160586 IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER ALLEGED SIMPLERA SENSOR DOES NOT HAVE A NEEDLE AFTER OPENED THE PACKAGING AND REPORTED AS PACKAGING NOT SEALED PROPERLY OR MISSHAPED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-5120A. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED PRODUCT DAMAGED UPON RECEIPT, PRIOR TO USE AND PACKAGING REPORTED AS NOT SEALED PROPERLY OR MISSHAPED NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-5120A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952842 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 79 YR Male