BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4 (INSULIN DELIVERY DEVICE) NA

    MDR report key: 1826428 · Received August 31, 2010

    Report

    Report Number
    9681821-2010-00031
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 19, 2010
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    20-986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED TO WORK FOR EVENING INJECTION [DEVICE FAILURE] ([BLOOD GLUCOSE INCREASED], [HYPERGLYCAEMIA], [BLOOD GLUCOSE ABNORMAL]). CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFORMATION: CLASS LLB. THIS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER AS "DEVICE FAILED TO WORK FOR EVENING INJECTION", "HYPERGLYCAEMIA", "BLOOD SUGAR LEVELS HAVE BEEN ERRATIC AND HIGH RECENTLY" AND CONCERNS A (B)(6) FEMALE PATIENT USING NOVOPEN 4 (DURABLE DEVICE) FROM AN UNKNOWN DATE AND WITH NOVORAPID PENFILL (RAPID-ACTING INSULIN ASPART) FROM UNKNOWN START DATE TO UNKNOWN DATE DUE TO AN UNKNOWN INDICATION. PATIENT'S HEIGHT AND MEDICAL HISTORY WAS NOT REPORTED. ON AN UNKNOWN DATE THE PATIENT PRESENTED WITH ERRATIC AND HIGH BLOOD GLUCOSE LEVELS. ON (B)(6) 2010, THE PATIENT'S NOVOPEN 4 FAILED TO WORK FOR THE EVENING INJECTION. THE PATIENT TRIED TO REPLACE THE CARTRIDGE AND NEEDLE BUT COULD NOT GET THE DEVICE TO FUNCTION. THE DEVICE HAD NOT BEEN DROPPED OR DAMAGED IN ANY WAY AND WAS NOT STORED WITH NEEDLE ATTACHED. THE PATIENT USED NOVOFINE 31G NEEDLE AND CHANGED THE NEEDLE AFTER EACH INJECTION. THE PATIENT HAS TRIED OTHER NEEDLES ON THE PEN BUT IT WOULD NOT WORK AT ALL. ON AN UNKNOWN DATE THE PATIENT WAS HOSPITALISED DUE TO HYPERGLYCAEMIA WITH BLOOD SUGARS RUNNING AT 21, THEREFORE, SHE HAS USED THE PRODUCT MORE THAN NORMAL. THIS CASE WAS RE-CLASSIFIED FROM NON-SERIOUS TO SERIOUS ON (B)(6) 2010 DUE TO INFORMATION RECEIVED REGARDING HOSPITALISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 4 (INSULIN DELIVERY DEVICE) NA INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA XUG0166

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization LEVEMIR (INSULIN DETEMIR)| SOLUTION FOR INJECTION, .0024 MOL/L| NOVOFINE 6MM (31G) (NEEDLE)