BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7040C2 GUARDIAN4 5PK OUS 2

    MDR report key: 20862631 · Received December 6, 2024

    Report

    Report Number
    2032227-2024-280896
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 6, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. 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 SENSOR GLUCOSE VS. BLOOD GLUCOSE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7040C2. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS REPORTING A DISCREPANCY BETWEEN SG AND BG WITH VALUES OF 13 MMOL/L AND 9 MMOL/L, RESPECTIVELY WHICH IS NOT WITHIN THE RANGE. CUSTOMER USING KALIUM CHLORIDE EQL PHARMA. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN FOR MMT-7040C2 IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078740 SENSOR MMT-7040C2 GUARDIAN4 5PK OUS 2 AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7040C2

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown