BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED 670G

    MDR report key: 12960552 · Received December 7, 2021

    Report

    Report Number
    MW5105898
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    December 2, 2021
    Report Date
    December 3, 2021
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE "RECALL REPLACEMENT" MEDTRONIC 670G CRACKED. IN THE 3 YEARS OF OWNING THIS PARTICULAR PUMP THE MODEL HAS FAILED 3 TIMES. ALSO THE GUARDIAN SENSOR HAD BEEN REPLACED AND FAILED AGAIN. I'M ATTACHING PICTURES OF THE "BLACK" BATTERY RING FAILURE AND CRACK DOWN THE ENTIRE BACK OF THE PUMP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853068 MEDTRONIC MINIMED 670G AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED
    1853069 MEDTRONIC MINIMED 670G AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED
    1853070 MEDTRONIC MINIMED 670G AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED
    1853071 SENSOR SENSOR, GLUCOSE, INVASIVE OZP MEDTRONIC MINIMED
    1853072 SENSOR SENSOR, GLUCOSE, INVASIVE OZP MEDTRONIC MINIMED

    Patients

    Seq Age Sex Outcome Treatment
    1 Female 81MG ASPIRIN| ATORVASTATIN | BUPROPION HCL ER| CALCIUM| COUNTOUR LINK BG MONITOR| DAILY MULTIVITAMIN| LEVOTHYROXINE| LORSTAN | POTASSIUM| VITAMIN D