BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE (30G) (NEEDLE) NA

    MDR report key: 1861837 · Received October 5, 2010

    Report

    Report Number
    9681821-2010-00034
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 16, 2010
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSULIN NOT COMING THROUGH NEEDLE WHEN INJECTING [DEVICE FAILURE] ([BLOOD GLUCOSE INCREASED]). NEEDLES WERE BLUNT; WAS UNCOMFORTABLE TO USE [NEEDLE ISSUE]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFO: CLASS LLB. THIS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY CONSUMER AS "PT HOSPITALIZED INTO INTENSIVE CARE AS BLOOD GLUCOSE WENT UP TO 35", "INSULIN NOT COMING THROUGH NEEDLE WHEN INJECTING" AND "NEEDLES WERE BLUNT; WAS UNCOMFORTABLE TO USE" AND CONCERNS A FEMALE PT OF UNK AGE USING NOVOFINE 30G 8 MM (NEEDLE) DUE TO TYPE 1 DIABETES. PT'S HEIGHT AND MEDICAL HISTORY WAS NOT REPORTED. ON AN UNK DATE, THE PT FELT THAT THE NEEDLES SHE WAS USING WERE BLUNT AND THEY WERE CAUSING HER PROBLEMS WHEN INJECTING, EITHER THE INSULIN WAS NOT FULLY COMING THROUGH THE NEEDLE OR IT WAS UNCOMFORTABLE TO USE. SHE DOES USE NEW NEEDLES EVERY TIME AND HAS NEVER EXPERIENCED THIS BEFORE BUT ALWAYS FELT THE NEEDLES WERE DIFFERENT. THE PT HAS CHECKED THE BATCH NUMBERS OF THE SUSPECTED NOVOFINE NEEDLES ARE NOT THE SAME AS THE FAKE ALERT BATCH NUMBERS, BUT SHE IS WONDERING IF THIS COULD BE A NEW ALERT. ON (B)(6)-2010, THE PT FELT UNWELL AND WAS THEN HOSPITALIZED INTO INTENSIVE CARE AS HER BLOOD SUGAR WENT UP TO 35 MMOL/L. THE PT WAS TREATED WITH UNSPECIFIED TREATMENT. THE PT WAS DISCHARGED FROM HOSPITAL ON (B)(6)-2010. THE OUTCOME OF THE EVENT "INSULIN NOT COMING THROUGH NEEDLE WHEN INJECTING" WAS REPORTED AS "UNK". THE OUTCOME OF THE EVENTS "PT HOSPITALIZED INTO INTENSIVE CARE AS BS WENT UP TO 35" AND "NEEDLES WERE BLUNT; WAS UNCOMFORTABLE TO USE" WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE (30G) (NEEDLE) NA NEEDLE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA 09G14K

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization HUMULIN S (INSULIN HUMAN) ONGOING| HUMULIN I (INSULIN HUMAN INJECTION, ISOPHANE)