BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3

    MDR report key: 1015016 · Received March 18, 2008

    Report

    Report Number
    9681821-2008-00013
    Event Type
    Injury
    Date Received
    March 18, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 18, 2008
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). PEN NOT EXPELLING INSULIN [DEVICE FAILURE] ([DIABETIC KETOACIDOSIS]). CASE DESCRIPTION: MEDICAL DEVICE INFORMATION: NOVOPEN3 AND NOVOPEN3 PENMATE: CLASS LLB. NOVOFINE 31G: CLASS LLA. THIS SPONTANEOUS REPORT, RECEIVED FROM UNITED KINGDOM AND REPORTED BY A CONSUMER AS "DIABETIC KETOACIDOSIS AND DEVICE FAILURE", CONCERNS A PATIENT (GENDER AND AGE UNKNOWN) TREATED WITH MIXTARD 30 PENFILL (DUAL ACTING HUMAN INSULIN FROM AN UNKNOWN DATE TOGETHER WITH NOVOPEN 3 (INSULIN DELIVERY DEVICE), NOVOPEN 3 PENMATE (INSULIN DELIVERY DEVICE) AND NOVOFINE 31G (NEEDLE) FOR INSULIN-DEPENDENT DIABETES MELLITUS AND DEVICE THERAPY. IN 2008, THE PATIENT WAS ADMITTED TO THE EMERGENCY UNIT WITH DIABETIC KETOACIDOSIS AND DISCHARGED ON TWO DAYS LATER. THE PATIENT WAS ADMITTED ON THE NEXT DAY AND DISCHARGED. THEN RE-ADMITTED AGAIN ON THE FOLLOWING DAY AND FINALLY DISCHARGED ON TWO DAYS LATER. DURING THE HOSPITALISATION, BLOOD TESTS, SCANS AND X-RAYS WERE PERFORMED. ALSO THE NOVOPEN 3 WAS TESTED AND WAS FOUND TO BE FAULTY. THE PEN WAS NOT EXPELLING INSULIN ALTHOUGH THE INSULIN DOSAGE WAS DIALLED UP ON THE PEN AND ONCE THE NEEDLE WAS INSERTED INTO THE STOMACH, THE DIAL WOULD GO TO ZERO BUT NO INSULIN WAS EXPELLED. THE OVERALL OUTCOME IS REPORTED AS "NOT REPORTED." REPORTER'S CAUSALITY: UNKNOWN. NOVO NORDISK CAUSALITY: REPORTABLE.

    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 HSC7129

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization