BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105ELBLNA ELI LILY BLUE

    MDR report key: 11886709 · Received May 26, 2021

    Report

    Report Number
    3012822846-2021-00275
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    November 4, 2020
    Report Date
    May 26, 2021
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000313
    Adverse Event
    Yes
    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'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PEN USER EXPERIENCED HIGH BLOOD GLUCOSE READINGS AND WAS HOSPITALIZED. THE CUSTOMER'S MOTHER ALLEGED THE INSULIN PEN WAS UNDER DELIVERING INSULIN DUE TO THE CUSTOMER'S BLOOD GLUCOSE NOT COMING DOWN AFTER BLOUSING WITH THE INSULIN PEN. IT IS UNKNOWN WHEN THE CUSTOMER WAS HOSPITALIZED OR THE HOSPITAL STAY DURATION. THE INSULIN PEN WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782680 INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELBLNA A92LY 000010862088000313

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization