BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 3 (INSULIN DELIVERY DEVICE) N/A

    MDR report key: 1893918 · Received November 2, 2010

    Report

    Report Number
    9681821-2010-00037
    Event Type
    Other
    Date Received
    November 2, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOW BLOOD GLUCOSE LEVELS [BLOOD GLUCOSE DECREASED]. INSULIN DELIVERY INCORRECT [INCORRECT DOSE ADMINISTERED BY DEVICE]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFO: CLASS IIB. SPONTANEOUS REPORT RECEIVED FROM (B)(6) AND REPORTED BY A CONSUMER AS "LOW BLOOD GLUCOSE LEVELS" AND "INSULIN DELIVERY INCORRECT". IT CONCERNS A (B)(6) MALE PATIENT TREATED WITH NOVOPEN 3 (INSULIN DELIVERY DEVICE) (DRUG FIRST DOSE UNK, DRUG STOP DATE UNK) FOR "TYPE 2 DIABETES MELLITUS". MEDICAL HISTORY INCLUDES TYPE 2 DIABETES MELLITUS. PATIENT'S HEIGHT: NOT REPORTED. A PATIENT REPORTED THAT HE HAD LOW BLOOD GLUCOSE LEVELS DURING USE OF NOVOPEN 3 ON (B)(6) 2010 DUE TO DIABETES MELLITUS. INSULIN DELIVERY INCORRECT. THE PATIENT WENT TO SEE HIS PHYSICIAN IMMEDIATELY AND RECEIVED GLUCOSE. WITH THAT HE RECOVERED. THE PATIENT HAS NOT BEEN TRAINED, BUT INJECTS HIMSELF. NO AIRSHOTS ARE DONE. HE REUSES THE NEEDLES AND THE PRODUCT IS NOT STORED PROPERLY. THE OVERALL OUTCOME IS REPORTED AS "RECOVERED".

    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 63 YR Other| R