BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105NNGYNA NOVO NORDISK GRAY

    MDR report key: 11925325 · Received June 2, 2021

    Report

    Report Number
    3012822846-2021-00492
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    November 15, 2020
    Report Date
    June 2, 2021
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000351
    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 REPORTED VIA PHONE CALL THAT THERE WERE MULTIPLE INACCURACIES BETWEEN THE DOSES INTENDED AND DOSES RECORDED. THE DOSES WERE GREATER THAN 1.0 UNIT OF INSULIN. THE CUSTOMER REPORTED THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 440 MG/DL. 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
    821336 INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNGYNA B92LN 000010862088000351

    Patients

    Seq Age Sex Outcome Treatment
    1