BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE 6MM (31G)`

    MDR report key: 3140102 · Received May 21, 2013

    Report

    Report Number
    9681821-2013-00019
    Event Type
    Other
    Date Received
    May 21, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    PMA / PMN Number
    K002403
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD GLUCOSE INCREASED VERY MUCH, 173 MG/DL (IN THE EARLY MORNING), AND 410 MG/DL (AT 12:30 AFTER PERFORMING HER INJECTION WITH HUMALOG) [BLOOD GLUCOSE INCREASED]. HER INSULIN DOSE WAS NOT INJECTED DUE TO BLOCKED NEEDLE [NEEDLE ISSUE]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE REPORTED BY A CONSUMER FROM GREECE, CONCERNS A (B)(6) FEMALE PT, WHO WAS TREATED WITH NOVOFINE 31G 6 MM (NEEDLE) FOR APPROX 20 YEARS AND EXPERIENCED "BLOOD GLUCOSE INCREASED VERY MUCH, 173 MG/DL (IN THE EARLY MORNING), AND 410 MG/DL (AT 12:30 AFTER PERFORMING HER INJECTION WITH HUMALOG)" AND "HER INSULIN DOSE WAS NOT INJECTED DUE TO BLOCKED NEEDLE" BEGINNING ON (B)(6) 2013. PT'S HEIGHT: (B)(6). MEDICAL HISTORY INCLUDES TYPE 1 DIABETES MELLITUS SINCE 1990, HYPERTHYROIDISM AND HYPERTENSION. THE PT CLAIMED THAT SHE ATTACHED A BRAND NEW NEEDLE NOVOFINE 31G 6 MM ON A HUMALOG MIX 25 DEVICE AND AS THE NEEDLE WAS BLOCKED, HER BLOOD GLUCOSE INCREASED VERY MUCH. HER BLOOD GLUCOSE VALUES ON (B)(6) 2013 WERE: 173 MG/DL (IN THE EARLY MORNING) AND 410 MG/DL (AT 12:30 AFTER PERFORMING HER INJECTION WITH HUMALOG. THE PT DID NOT RECEIVE ANY TREATMENT AND WAS NOT HOSPITALIZED. SHE REPORTED THAT HER INSULIN DOSE WAS NOT INJECTED DUE TO BLOCKED NEEDLE. THIS EVENT HAD "RE-APPEARED DURING THE REPORTER TREATMENT." THE PT WAS AN EXPERIENCED USER AS SHE USED NOVOFINE FOR APPROX 20 YEARS, HAD TAKEN PROPER TRAINING, USED THEM FOR SINGLE USE ONLY AND FOLLOWED THE INSTRUCTIONS FOR NEEDLES USE. THE REPORTER SUSPECTED THAT THE RE-OCCURRENCE OF THE EVENT WAS DUE TO THE MFG SITE OF (B)(4). THE PT ROTATED THE INJECTION SITES AND PERFORMED THE INJECTIONS SUBCUTANEOUSLY. SHE HAD NOT EXPERIENCED ALLERGIC PROBLEMS AND ADHERED TO THE TREATMENT DIRECTIONS GIVEN BY HER PHYSICIAN. ON AN UNK DATE, THE PT STARTED USING NEEDLES FROM A NEW PACKAGE OF NOVOFINE 31G 6 MM AND THE BLOOD GLUCOSE LEVELS DECREASED AFTER THE USE OF NEW INSULIN DEVICE AND NEW NEEDLES. ACTION TAKEN TO NOVOFINE 31G 6 MM WAS REPORTED AS NO CHANGE. THE OUTCOME OF "BLOOD GLUCOSE INCREASED VERY MUCH, 173 MG/DL (IN THE EARLY MORNING) AND 410 MG/DL (AT 12:30 AFTER PERFORMING HER INJECTION WITH HUMALOG)" WAS REPORTED AS RECOVERED. THE OUTCOME OF "HER INSULIN WAS NOT INJECTED DUE TO BLOCKED NEEDLE" WAS NOT REPORTED. THIS CASE WAS UPGRADED TO SERIOUS ("MEDICALLY SIGNIFICANT") BY NOVO NORDISK ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225297 NOVOFINE 6MM (31G)` NEEDLE FMI NOVO NORDISK A/S NA 11L03M

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other THYROHORMONE (LEVOTHYROXINE SODIUM)| GLUCOPHAGE (METFORMIN HYDROCHLORIDE)| PROTAMINE SUSPENSION)| CONCOR (BISOPROLOL FUMARATE)| HUMALOG MIX (INSULIN LISPRO, INSULIN LISPRO