BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO

    MDR report key: 722051 · Received June 1, 2006

    Report

    Report Number
    9681821-2006-00047
    Event Type
    Injury
    Date Received
    June 1, 2006
    Date of Event
    March 4, 2005
    Report Date
    May 3, 2006
    Manufacturer
    NOVO NORDISK A/S - MEDICAL SYSTEMS
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILURE (DEVICE FAILURE) (BLOOD GLUCOSE INCREASED)CASE DESCRIPTION: THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER AS "BLOOD GLUCOSE INCREASED", CONCERNS A FEMALE TREATED WITH LEVEMIR PENFILL (INSULIN DETEMIR) FROM AN UNKNOWN DATE AND ONGOING DUE TO DIABETES MELLITUS.DUE TO DIFFICULTIES CONTROLLING THE BLOOD GLUCOSE, AND TO METABOLIC DISEASE THE PATIENT HAS HER BLOOD VALUES CHECKED EVERY 3 MONTH. ON 04-MAR-2005, THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE VALUES AND SHE WAS ADMITTED TO THE HOSPITAL WITH HYPERGLYCAEMIA A FEW DAYS LATER. IT IS REPORTED THAT NO INSULIN WAS RELEASED AS THE PISTON HAD NO CONTACT WITH THE RUBBER MEMBRANE. SHE WAS HOSPITALIZED FOR 10-11 DAYS BECAUSE OF UNSTABLE BLOOD SUGAR LEVELS. REPORTEDLY THE PATIENT DID NOT PERFORM AIRSHOTS BEFORE INJECTIONS. THE PATIENT WAS RE-INSTRUCTED TO ALWAYS MAKE SURE THAT THE PISTON AND RUBBER MEMBRANE WAS IN CONTACT. REPORTEDLY, THE PATIENT RECOVERED COMPLETELY FROM THE EVENT.THIS CASE IS LINKED TO A SIMILAR EPISODE THAT OCCURRED APPROXIMATELY TWO WEEKS LATER, REPORTED IN MFR. REPORT #9681821-2006-00046 (PATIENT IDENTIFIER 253069).COMMENT: REPORT CAUSALITY: UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization