BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPHONE ANDROID APP: PUMP CONNECT

    MDR report key: 14332102 · Received May 8, 2022

    Report

    Report Number
    2032227-2022-184114
    Event Type
    Malfunction
    Date Received
    May 8, 2022
    Date of Event
    April 22, 2022
    Report Date
    April 27, 2022
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    PKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INDICATED THAT THE CUSTOMER HAD ISSUE WITH MINIMED MOBILE APP. CUSTOMER WAS ASSISTED WITH MINIMED MOBILE APP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383515 SMARTPHONE ANDROID APP: PUMP CONNECT PKU MEDTRONIC MINIMED MMT-6101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown