BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUO

    MDR report key: 406169 · Received July 23, 2002

    Report

    Report Number
    9681821-2002-00034
    Event Type
    Injury
    Date Received
    July 23, 2002
    Date of Event
    July 3, 2002
    Report Date
    July 3, 2002
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIABETIC KETOACIDOSIS[DIABETIC KETOACIDOSIS]. CASE DESCRIPTION: A NURSE REPORTED THAT A PATIENT WITH TYPE I DIABETES WAS HOSPITALIZED IN 2002 WITH DIABETIC KETOACIDOSIS (DKS) DURING USE WITH NOVOLOG PENFILL (INSULIN ASPART) AND AN INDUO INSULIN DOSER. THE EVENT OCCURRED WITH ONE PARTICULAR CARTRIDGE OF NOVOLOG PENFILL. THE NURSE STATED THAT THE INSULIN IN THE SUSPECTED CARTRIDGE WAS BELOW WIH BLUE LINE (THE LABEL BAND) ON THE CARTRIDGE FOR SEVERAL DAYS PRIOR TO THE EVENT, THEREFORE, THE NURSE BELIEVED THAT THE PATIENT WAS NOT RECEIVING ANY INSULIN WHEN THEY PERFORMED THEIR INJECTIONS DURING THAT TIME. THE PATIENT WAS ADMITTED TO THE HOSPITAL IN 2002 WITH A BLOOD GLUCOSE LEVEL OF 427 MG/DL AND ACIDOSIS. PT WAS TREATED WITH A CONTINUOUS INFUSION OF REGULAR INSULIN, AND THEIR BLOOD GLUCOSE LEVELS AND ACIDOSIS NORMALIZED WITHIN 24 HOURS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 2 DAYS LATER AND CONTINUES TO USE THE PRODUCTS IN QUESTION. THE NURSE ALSO INDICATED THAT THE PATIENT IS NON-COMPLIANT WITH THEIR DIABETIC DIET AND HAS BEEN HOSPTALIZED MULTIPLE TIMES IN THE PAST FOR DKA. PT DID NOT HAVE ANY CHANGES IN THEIR DIET, MEDICATIONS ACTIVITY LEVEL OR HEALTH STATUS PRIOR TO THIS EVENT. THE NURSE ALSO STATED THAT THEY OBSERVED THE PATIENT USING THE INDUO INSULIN DOSER WHILE PT WAS IN THE HOSPITAL AND NURSE NOTICED THAT PT DID NOT DO AN AIR SHOT WITH EVERY INJECTION. THE PATIENT TOLD THE NURSE THAT PT WAS INSTRUCTED TO ONLY DO THE AIR SHOT WHEN PT CHANGED THE DISPOSABLE NEEDLE. PT HAD BEEN USING THE DOSER THREE TO FOUR TIMES A DAY AND ONLY CHANGED THE NEEDLE ONCE A DAY. THE PATIENT HAS BEEN RECOVERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUO INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization