BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 3 (INSULIN DELIVERY DEVICE) N/A

    MDR report key: 2181517 · Received July 12, 2011

    Report

    Report Number
    9681821-2011-00024
    Event Type
    Other
    Date Received
    July 12, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 15, 2011
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    19-938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSULIN COULD NOT BE DELIVERED NORMALLY [DEVICE FAILURE] ([BLOOD GLUCOSE INCREASED]). CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL INFORMATION: CLASS IIB. THIS REGULATORY AUTHORITY CASE FROM (B)(6) WAS REPORTED BY A MEDICAL DOCTOR AS "INSULIN COULD NOT BE DELIVERED NORMALLY" AND "BLOOD GLUCOSE WAS 13.4" AND CONCERNS A (B)(6) MALE PATIENT USING NOVOPEN 3 FROM AN UNKNOWN DATE FOR DEVICE THERAPY. PATIENT'S HEIGHT: NOT REPORTED. MEDICAL HISTORY INCLUDES DIABETES MELLITUS. ON AN UNKNOWN DATE THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO "POST-TRAUMATIC PAIN OF HEAD AND CHEST FOR MORE THAN 3H" AND "TRAUMATIC SUBARACHNOID HEMORRHAGE, BILATERAL PLEURAL EFFUSION AND DIABETES MELLITUS". THE PATIENT RECEIVED TREATMENT FOR REDUCING INTRACRANIAL PRESSURE, ANTIBIOTIC THERAPY, FLUID REPLACEMENT AND REDUCING BLOOD GLUCOSE. THE DAILY DOSE OF INSULIN WAS 20IU IN THE MORNING AND 16IU AT NIGHT. THE INSULIN WAS INJECTED SUBCUTANEOUSLY BY NOVOPEN 3. ON THE MORNING OF (B)(6) 2011, 20IU OF INSULIN WAS INJECTED BY NOVOPEN AND 20 MINUTES LATER AFTER INJECTION, IT WAS FOUND THAT INSULIN HAD NOT BEEN INJECTED COMPLETELY. THE PATIENT'S BLOOD GLUCOSE WAS 10.9 (UNIT WAS NOT REPORTED) AFTER CHANGING TO USE NOVOPEN 4. THE OVERALL OUTCOME WAS NOT REPORTED. THE PATIENT HAD BEEN USING THE SUSPECTED NOVOPEN 3 FOR ABOUT A YEAR. THE OPERATORS WERE REPORTED TO BE NURSES AND THE OPERATOR AT THE TIME OF THE EVENT WAS A NURSE. IT IS UNKNOWN IF THE NOVOPEN 3 WAS STORED ACCORDING TO RECOMMENDATIONS. THE NEEDLES WERE ONLY USED ONCE, BUT IT WAS NOT REPORTED IF AIR-SHOTS OR FUNCTION CHECKS WERE PERFORMED. THE SUSPECTED DEVICE WILL NOT BE RETURNED FOR INVESTIGATION AND NO BATCH NUMBER WAS REPORTED. FINAL COMMENT FROM THE MANUFACTURER: (B)(6) 2011. AS NO PEN HAS BEEN RETURNED TO NOVO NORDISK A/S FOR INVESTIGATION AND LIMITED INFORMATION REGARDING THE PATIENT'S HANDLING OF THE PEN AND LIFESTYLE IS AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT CAUSE FOR THE EXPERIENCED EVENT. HOWEVER THE REPORTING RATE FOR HYPERGLYCAEMIC RELATED EVENTS SEEN IN CONNECTION TO NOVOPEN 3 USE IS LOW AND STABLE. REPORTER COMMENT: THE REPORT PHYSICIAN EVALUATED THE EVENT AS "POSSIBLY CAUSING PERMANENTLY INJURY IN STRUCTURE AND FUNCTION OF HUMAN BODY", AND REPORTED THAT THE PRELIMINARY CAUSE ANALYSIS WAS "THE PISTON ROD OF NOVOPEN 3 WAS TOO PLIABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 3 (INSULIN DELIVERY DEVICE) N/A INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other INSULIN (INSULIN)