BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP

    MDR report key: 14592895 · Received June 2, 2022

    Report

    Report Number
    MW5110073
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 31, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MEDTRONIC MINIMED, INC.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NOTIFICATION WAS RECEIVED FROM MEDTRONIC ON 5/27/2022 THAT THE BATTERY CAP FOR THE MEDTRONIC MINIMED 670G INSULIN PUMP I USE HAS ISSUES. I WAS INSTRUCTED TO CHECK THE CAP ON MY PUMP. I NOTICED ONE OF THE MELTED POSTS HOLDING IN THE METAL BATTERY CONTACT HAD BROKEN OFF THE COMPONENT. THE PUMP IS STILL FUNCTIONING. I HAVE REQUESTED A REPLACEMENT CAP. I WILL MONITOR THE CAP FOR FURTHER DAMAGE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686131 670G INSULIN PUMP AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED, INC. 670G

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female INSULIN | INSULIN PUMP| IRON SUPPLEMENT| MULTIVITAMIN | SYNTHROID| VITAMIN D