BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN SENSOR 3

    MDR report key: 12973996 · Received December 10, 2021

    Report

    Report Number
    2032227-2021-228755
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 9, 2021
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A DELIVERY SUSPENSION. THE CUSTOMER¿S BLOOD GLUCOSE WAS 105 MG/DL AND SENSOR GLUCOSE WERE 63 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE WAS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS NOT REPORTED. CUSTOMER STATED DIFFERENCE BETWEEN BLOOD GLUCOSE VALUE AND SENSOR GLUCOSE VALUE WAS 42 MG/DL. THE CUSTOMER ALSO REPORTED THE CANNULA OF THE SENSOR WAS BENT FORMING THE TIP LIKE A LETTER J. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879378 GUARDIAN SENSOR 3 ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020LA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male