BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-5120A SIMPLERA SYNC 5PK US

    MDR report key: 24994100 · Received April 27, 2026

    Report

    Report Number
    2032227-2026-166450
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 27, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    UDI-DI
    000020763000956381
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR CARELINK ADDITIONAL INVESTIGATION WAS PERFORMED FOR THE SENSOR GLUCOSE VS. BLOOD GLUCOSE ISSUE. 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 A DISCREPANCY BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE VALUE. THE EVENT INVOLVED PRODUCT MMT-5120A. THE CUSTOMER ALSO EXPERIENCED HYPERGLYCEMIA WHICH WAS TREATED WITH HOSPITALIZATION. THE CUSTOMER ALSO EXPERIENCED HYPOGLYCEMIA. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER DID NOT TAKE MEDICATION SUCH AS ACETAMINOPHEN, PARACETAMOL, OR HYDROXYUREA (ALSO KNOWN AS HYDROXYCARBAMIDE). THE DISCREPANCY BETWEEN THE SENSOR GLUCOSE VALUE OF 58 MG/DL AND THE BLOOD GLUCOSE VALUE OF 170 MG/DL WAS NOT WITHIN THE ACCEPTABLE RANGE. INSULIN DELIVERY WAS NOT SUSPENDED DUE TO SENSOR GLUCOSE VALUE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-5120A WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WOULD BE RETURNED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11630 SENSOR MMT-5120A SIMPLERA SYNC 5PK US SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120A HG92YBP 000020763000956381

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male