BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN ECHO

    MDR report key: 3964013 · Received July 9, 2014

    Report

    Report Number
    9681821-2014-00033
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 19, 2014
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K123766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF DEVICE TO ACTUALLY DELIVER INSULIN [DEVICE FAILURE] ADMITTED WITH DIABETIC KETOACIDOSIS (DKA) [DIABETIC KETOACIDOSIS] BECAME VERY UNWELL [MALAISE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE (B)(6) WS RECEIVED VIA (B)(6) AND REPORTED BY A GENERAL PRACTITIONER AS "FAILURE OF DEVICE TO ACTUALLY DELIVER INSULIN" WITH AN UNSPECIFIED ONSET DATE, "ADMITTED WITH DIABETIC KETOACIDOSIS (DKA)" AND "BECAME VERY UNWELL" BOTH BEGINNING ON (B)(6) 2014, AND CONCERNED A FEMALE PATIENT (AGE NOT REPORTED) WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) SUBCUTANEOUSLY AS DEVICE THERAPY FROM (B)(6) 2014 DUE TO "ILL-DEFINED DISORDER" AND "TYPE 1 DIABETES MELLITUS", PATIENT'S HEIGHT, WEIGHT AND BMI WERE NOT REPORTED. MEDICAL HISTORY INCLUDES TYPE 1 DIABETES MELLITUS AND ILL-DEFINED DISORDER. CONCOMITANT PRODUCTS INCLUDED - LEVEMIR (INSULIN DETERMIR), NOVORAPID (INSULIN ASPART), PRAVASTATIN (PRAVASTATIN), AMLODIPINE(AMLODIPINE), FENOFIBRATE (FENOFIBRATE), CANDESARTAN (CANDESARTAN) AND CETIRIZINE (CETIRIZINE). REPORTER CONFIRMED THAT PATIENT STILL HAVE THE PEN AND WOULD RETURN IT FOR INVESTIGATION. THE OUTCOME FOR THE EVENT "FAILURE OF DEVICE TO ACTUALLY DELIVER INSULIN" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "ADMITTED WITH DIABETIC KETOACIDOSIS (DKA)" AND BECAME VERY UNWELL" WAS RECOVERED ON (B)(6) 2014. ACTION TAKEN FOR REACTION : PRODUCT WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401742 NOVOPEN ECHO INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening NOVORAPID (INSULIN ASPART) SOLUTION OR INJECTION,| FENOFIBRATE (FENOFIBRATE)| CETIRIZINE (CETIRIZINE)| CANDESARTAN (CANDESARTAN)| LEVEMIR (INSULIN DETERMIR) SOLUTION FOR INJECTIN,| PRAVASTATIN (PRAVASTATIN)| 100 U/ML| .0024 MOL/L| AMLODIPINE (AMLODIPINE)