BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 3

    MDR report key: 2818428 · Received October 16, 2012

    Report

    Report Number
    9681821-2012-00022
    Event Type
    Other
    Date Received
    October 16, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 19, 2012
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS LEVELS WENT DOWN TO 2MMOL/L [BLOOD GLUCOSE DECREASED] THINKS HE HAS TAKEN TOO MUCH INSULIN [ACCIDENTAL OVERDOSE]. FADED NUMBERS ON THE PEN AND THE INSPECTION WINDOW IS SCRATCHED. [DEVICE PHYSICAL PROPERTY ISSUE]. BLOOD SUGAR LEVELS WERE DOWN TO 1.6MMOL/L [BLOOD GLUCOSE DECREASED]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THE SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER AS "FADED NUMBERS ON THE PEN AND THE INSPECTION WINDOW IS SCRATCHED," "THINKS HE HAS TAKEN TOO MUCH INSULIN," BLOOD SUGAR LEVELS WERE DOWN TO 1.6 MMOL/L" AND HIS LEVELS WENT DOWN TO 2 MMOL/L." IT CONCERNS A MALE PT, WHO WAS TREATED WITH NOVOPEN 3 (INSULIN DELIVERY DEVICE), FOR DEVICE THERAPY. PT WEIGHT NOT REPORTED. MEDICAL HISTORY: NOT REPORTED. ON AN UNK DATE, REPORTER STATED THAT THE NUMBERS ON THE PEN WERE FADED AND THE INSPECTION WINDOW WAS SCRATCHED AND CLOUDY. THE PT THOUGHT THAT HE HAD TAKEN TOO MUCH INSULIN AND AN AMBULANCE WAS CALLED TWICE DUE TO HIS LOW BLOOD SUGAR LEVELS. ON (B)(6) 2012, PT'S BLOOD SUGAR LEVELS WERE DOWN TO 1.6 MMOL/L WHEN THE AMBULANCE ARRIVED PT'S BLOOD SUGAR LEVELS WERE BACK TO 10 MMOL/L AND WHEN THEY WERE PUTTING THE PT INTO THE AMBULANCE HIS BLOOD SUGAR LEVELS WENT BACK TO 1 MMOL/L. THE PT WAS TAKEN TO HOSPITAL, BUT WAS NOT ADMITTED OVERNIGHT. ON (B)(6) 2012, WHEN THE PT WAS AT THE MEDICAL CENTER WAITING TO SEE HIS DOCTOR, HIS BLOOD SUGAR LEVELS WENT DOWN TO 2 MMOL/L. AMBULANCE WAS CALLED AGAIN AND THE PT WAS TAKEN TO HOSPITAL, BUT WAS NOT ADMITTED. THE PT WAS ASKED TO KEEP IN CLOSE CONTACT WITH HIS DIABETES EDUCATOR. IT WAS CONCLUDED THAT THE PT WOULD HAVE INJECTED HIMSELF TOO MUCH INSULIN, AS HE COULD NOT SEE THE NUMBERS ON THE DOSAGE SELECTOR. ACTION TAKEN TO NOVOPEN 3 WAS NOT REPORTED. OVERALL OUTCOME FOR THE EVENTS WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention INJECTION| MIXTARD 30/70 (INSULIN HUMAN) SUSPENSION FOR