BEUDAMED
    FDA Adverse Event Death Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 14696492 · Received June 15, 2022

    Report

    Report Number
    3012822846-2022-00859
    Event Type
    Death
    Date Received
    June 15, 2022
    Date of Event
    April 23, 2022
    Report Date
    June 15, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2022 AT HOME. THE CAUSE OF DEATH WAS DIABETES KETOACIDOSIS. CUSTOMER DID NOT HAVE ANY OTHER HEALTH ILLNESS THAT MIGHT HAVE LED TO HER PASSING. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PEN DURING THE TIME OF THE EVENT. IT WAS UNKNOWN WHETHER THE CALLER WILL RETURNED THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627992 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA B0039 000010862088000368

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Death