BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN

    MDR report key: 11872040 · Received May 24, 2021

    Report

    Report Number
    2032227-2021-148405
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    December 2, 2019
    Report Date
    May 24, 2021
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS MDR IS RELATED TO THE RETROSPECTIVE REVIEW OF COMPLAINTS FROM COMPANION MEDICAL INC, FOLLOWING MEDTRONIC¿S ACQUISITION OF THE COMPANY IN SEPTEMBER 2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PEN NEVER WORKED. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PEN WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770156 INPEN INPEN FMF MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1