BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVO

    MDR report key: 722090 · Received June 1, 2006

    Report

    Report Number
    9681821-2006-00046
    Event Type
    Injury
    Date Received
    June 1, 2006
    Date of Event
    March 1, 2006
    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 REPORT, REPORTED BY CONSUMER, AND REPORTED AS "BLOOD GLUCOSE INCREASED", CONCERNS A FEMALE PATIENT TREATED WITH INNOVO GREEN (INSULIN DELIVERY DEVICE) AND LEVEMIR FLEXPEN 100 UM1/3 (INSULIN DETERMIR) DUE TO INSULIN-REQUIRING TYPE II DIABETES MELLITUS. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL DUE TO ANOTHER ILLNESS. WHILE IN THE HOSPITAL, SHE DID NOT REMEMBER TO MAKE A FUNCTION CHECK OF THE DEVICE AND AS A RESULT DID NOT GET ENOUGH INSULIN. THIS WAS DISCOVERED WHEN HER BLOOD GLUCOSE AGAIN WAS FOUND TO BE HIGH, 256 TO 30 MMOI/L. SHE WAS KEPT IN THE 'HOSPITAL ONE EXTRA DAY DUE TO THIS. THE EVENT WAS TREATED WITH ACTRAPID. THE WOMAN IN QUESTION IS NOW REINSTRUCTED IN THE AIR SHOT PROCEDURE AND THAT THE NEEDLE SHOULD BE REMOVED DIRECTLY AFTER INJECTION AND THAT THE NEW NEEDLE SHOULD NOT BE PUT ON BEFORE THE NEW INJECTION IS PERFORMED. AS THE PATIENT'S DIABETES IS DIFFICULT TO CONTROL THE PATIENT IS FOLLOWED CLOSELY.THE PATIENT HAS RECOVERED COMPLETELY FROM THE EVENT.REPORTEDLY, THE PATIENT HAS USED INNOVO FOR APPROXIMATELY 6 MONTHS WHEN SHE EXPERIENCED THE FIRST EVENT. AT THAT TIME SHE DID NOT PERFORM AIRSHOTS BEFORE INJECTIONS. THE CASE IS LINKED TO ARGUS CASE NO. 253072.TECHNICAL EXAMINATIONS WERE PERFORMED.THE DOSE ACCURACY WAS MEASURED BY WEIGHING. THE PENFILL CARTRIDGE RETURNED WITH THE DELIVERY DEVICE WAS USED. THE RESULT WAS WITHIN ACCEPTABLE LIMITS. DURING TESTING OF THE DEVICE IF HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. PRODUCT: LEVEMIR PENFILL 100 U/ML 3 MLLOT NO: PQ50876THE RETURNED PRODUCT WAS EXAMINED VISUALLY. FURTHERMORE, THE PARAMETERS IDENTITY, ASSAY AND INSULIN DETEMIR RELATED IMPURITIES WERE EXAMINED. THE INSULIN WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DUE TO INSUFFICIENT COMPLAINT SAMPLE MATERIAL NO FURTHER INVESTIGATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVO INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S -MEDICAL SYSTEMS NA PW40011

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization