BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR MMT-5120B SIMPLERA SYNC 1PK US

    MDR report key: 24664229 · Received March 23, 2026

    Report

    Report Number
    2032227-2026-147148
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    February 28, 2026
    Report Date
    March 23, 2026
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    SFI
    UDI-DI
    000000763000956394
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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¿S MOTHER CALLED TO REPORT A SIGNIFICANT DISCREPANCY BETWEEN SENSOR GLUCOSE (SG) AND BLOOD GLUCOSE (BG) READINGS. THE EVENT INVOLVED PRODUCT(S) MMT-5120B,MMT-332A,MMT-242A,MMT-1884. THE BG (METER READING) WAS 400 MG/DL, A DIFFERENCE OF 188 MG/DL, WHICH IS OUTSIDE THE TARGET RANGE. THE CUSTOMER EXPERIENCED A HIGH BG EVENT, WHICH LASTED 3¿4 HOURS AND WAS MANAGED WITH A MANUAL INSULIN INJECTION, KETONES MONITORING. TROUBLESHOOTING WAS NOT PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THERE IS NO MENTION OF THE AUTO MODE FEATURE AT THE TIME OF THE EVENT. NO FURTHER CUSTOMER COMPLICATIONS WERE REPORTED. MMT-5120B WAS EXPECTED TO RETURN. MMT-332A,MMT-242A,MMT-1884 WAS NOT EXPECTED TO RETURN. FRN-MMT-332A-RSVR, UNOMED INF SET, SFI-MMT-5120B-SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728834 SENSOR MMT-5120B SIMPLERA SYNC 1PK US SENSOR, GLUCOSE, INVASIVE, COMPONENT OF AUTOMATED INSULIN DELIVERY SYSTEM SFI MEDTRONIC MINIMED MMT-5120B HG92UWP 000000763000956394

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Other