BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 3 DEMI

    MDR report key: 3190107 · Received June 21, 2013

    Report

    Report Number
    9681821-2013-00025
    Event Type
    Other
    Date Received
    June 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMF
    PMA / PMN Number
    19-938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUSPECT OLDER NOVOPENS WHICH I BELIEVE ARE DELIVERING INCONSISTENT DOSAGES [INCORRECT DOSE ADMINISTERED BY DEVICE]. UNEXPECTED HYPOS DEVELOPING FOR NO APPARENT REASON AND THE UNUSUALLY HIGH READINGS THAT I WAS ALSO EXPERIENCING WITH APPARENT REASON [DIABETES MELLITUS INADEQUATE CONTROL]. AT TIMES HAVE RESULTED IN QUITE SEVERE HYPOS THAT HAVE REQUIRED AMBULANCE ASSISTANCE ON SEVERAL OCCASIONS [HYPOGLYCAEMIA]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER AS "AT TIMES HAVE RESULTED IN QUITE SEVERE HYPOS THAT HAVE REQUIRED AMBULANCE ASSISTANCE ON SEVERAL OCCASIONS", "SUSPECT OLDER NOVOPENS WHICH I BELIEVE ARE DELIVERING INCONSISTENT DOSAGES" AND "UNEXPECTED HYPOS DEVELOPING FOR NO APPARENT REASON AND THE UNUSUALLY HIGH READINGS THAT I WAS ALSO EXPERIENCING WITH APPARENT REASON." IT CONCERNS A MALE PATIENT (AGE UNKNOWN) WITH INSULIN-DEPENDENT DIABETES MELLITUS, WHO WAS TREATED WITH NOVORAPID PENFILL (FAST-ACTING INSULIN ASPART) AND ACTRAPID HM PENFILL (FAST-ACTING INSULIN HUMAN) AND NOVOPEN 3 DEMI (INSULIN DELIVERY DEVICE) FROM AN UNKNOWN DATE. PATIENT'S HEIGHT: NOT REPORTED. MEDICAL HISTORY INCLUDES INSULIN-DEPENDENT DIABETES MELLITUS FOR ABOUT 50 YEARS AND HAS A VERY GOOD GRASP ON CARE AND ATTENTION TO DIABETIC MATTERS. IN THE LAST 10 YEARS, THE PATIENT HAS BEEN DOING SIX BLOOD SUGAR LEVEL TESTS PER DAY, INCLUDING AS EXTRA TESTS, MID-MORNING AND MID-AFTERNOON IN ORDER TO BE ABLE TO COUNTER IMMEDIATELY ANY VARIATIONS THAT MAY OCCUR IN BLOOD SUGAR LEVELS. THE PATIENT COMPLAINED OF 2 NOVOPEN DEMI WHICH WERE MORE THAN 15 YEARS OLD. THE PATIENT BELIEVED THE PENS WERE DELIVERING INCONSISTENT DOSAGES WHICH AT TIMES HAD RESULTED IN QUITE SEVERE HYPOS THAT REQUIRED AMBULANCE ASSISTANCE ON SEVERAL OCCASIONS. THE PATIENT FOUND THAT THE DOSAGE DELIVERED WAS SOMETIMES CORRECT BUT ALSO SOMETIMES INCONSISTENT AND QUITE IRREGULAR IN DOING SO. HENCE, THERE APPEARED TO BE NO ASSURANCE WHETHER THE PRECISE AMOUNT DIALLED UP ON THE PEN FOR DELIVERY WOULD BE THE AMOUNT DELIVERED. THE PATIENT FELT THAT THE DELIVERY SYSTEM WAS NOT OF A CONSISTENT QUANTITY WHERE ALLOWANCES FOR ERROR COULD BE COMPENSATED FOR WHEN DIALLING UP THE AMOUNT OF INSULIN FOR DELIVERY ON THE PEN. THE PATIENT HAD MENTIONED TO HIS GENERAL PRACTITIONER, DIABETES EDUCATOR AND DIABETES SPECIALIST ABOUT THE UNEXPECTED HYPOS DEVELOPING FOR NO APPARENT REASON AND THE UNUSUALLY HIGH READINGS THAT HE WAS ALSO EXPERIENCING WITH NO APPARENT REASON. APART FROM THE SUGGESTION THAT HE SHOULD PERHAPS GET BLOOD SUGAR TEST METER CHECKED OUT, NOT ONE OF THEM THOUGHT TO SUGGEST THAT PERHAPS THE PROBLEM COULD BE ATTRIBUTED TO MY DIAL UP INSULIN PENS. THE PATIENT REPORTED THAT SINCE USING NEW NOVOPEN ECHOS HE HAS NOT HAD ANY NOTICEABLE PROBLEM REGARDING DOSAGE DELIVERY AND IS VERY IMPRESSED WITH THE EASIER AND MORE EFFICIENT MANNER IN WHICH THESE NEW NOVOPEN ECHOS CAN BE USED WITH COMPLETE CONFIDENCE IN NORMAL DAILY USAGE. ACTION TAKEN TO NOVORAPID PENFILL, ACTRAPID HM PENFILL AND NOVOPEN 3 DEMI WAS NOT REPORTED. THE OVERALL OUTCOME OF THE EVENTS WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282917 NOVOPEN 3 DEMI INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S NA KW40034

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention