BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 11924872 · Received June 2, 2021

    Report

    Report Number
    3012822846-2021-00487
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    November 5, 2020
    Report Date
    June 2, 2021
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000368
    Adverse Event
    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 THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING RANGED FROM 226 - 450 MG/DL. THE CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PEN WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819195 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA B92FT 000010862088000368

    Patients

    Seq Age Sex Outcome Treatment
    1