BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 11873907 · Received May 25, 2021

    Report

    Report Number
    3012822846-2021-00227
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    May 14, 2020
    Report Date
    May 24, 2021
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000368
    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

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INPEN IS NOT DELIVERING DOSES CORRECTLY. BLOOD GLUCOSE AT THE TIME OF CALL IS 566 MG/DL. CUSTOMER CHANGED THE CARTRIDGE THE NIGHT BEFORE AND HAD A RECOMMENDATION OF 18 UNITS IN THE MORNING BUT REGISTERED MULTIPLE SMALLER DOSES THAT ADDED UP TO 17.5 UNITS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773802 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA B92EW 000010862088000368

    Patients

    Seq Age Sex Outcome Treatment
    1