BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3

    MDR report key: 833660 · Received March 28, 2007

    Report

    Report Number
    9681821-2007-00008
    Event Type
    Injury
    Date Received
    March 28, 2007
    Date of Event
    December 1, 2006
    Report Date
    February 28, 2007
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULT: PRODUCT: NOVOPEN 3, LOT NO. RV40064. DEVICE CONCLUSION: VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. AN INTERNAL PEN PART (NUT CAP) HAS COME LOOSE. DUE TO THIS FAULT, THE MOVEMENT ACCURACY OF THE PISTON ROD WAS NOT MEASURED. THE OBSERVED PROBLEM WITH THE LOOSE INTERNAL PEN PART (NUT CAP) IS CAUSED BY ACCIDENTAL DAMAGE OR INCORRECT HANDLING DURING USE. IT WAS NOT POSSIBLE TO MEASURE THE MOVEMENT ACCURACY OF THE PISTON. PRODUCT: NOVOPEN 3, LOT NO.: 961812 DEVICE CONCLUSION: TECHNICAL, VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. SOME PART OF THE DOSAGE SELECTOR IS MISSING, DUE TO THIS IT IS WERY DIFFICULT TO DIAL A DOSE. THE OBSERVED FAULT ON THE DOSE SLECTOR IS A RESULT OF ACCIDENTAL DAMAGE DURING USE OF THE DEVICE. DUE TO THIS FAULT, THE DOSE ACCURACY WAS NOT MEASURED. THE OBSERVED PROBLEM COULD NOT BE RELATED TO ANY NOVO NORDISK PROCESSES. THE OUTCOME IS REPORTED AS RECOVERED. REPORTER'S CAUSALITY: UNKNOWN. NOVO NORDISK'S CAUSALITY: REPORTABLE.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] THE PISTON BROKE [DEVICE BREAKAGE] ([HYPERGLYCAEMIA]). CASE DESCRIPTION: THIS SPONTANEOUS REPORT BY A CONSUMER, RECEIVED FROM ANOTHER COUNTRY AND REPORTED AS "HYPERGLYCAEMIA" AND "THE PISTON BROKE", CONCERNS A FEMALE PT USING NOVOPEN 3 FOR DEVICE THERAPY. THE PT HAS SUFFERED FROM DIABETES MELLITUS INSULIN-DEPENDENT FOR THE LAST 20 YEARS. IN LATE 2006, THE PT EXPERIENCED HYPERGLYCAEMIA, BUT THE PT THOUGHT THAT IT WAS BECAUSE OF INFLUENZA. FASTING BLOOD GLUCOSE REACHED 3.5 G/L. THE PT NOTICED THAT THERE WAS NO SOUND AS USUAL THAT INDICATES THAT THE DOSE WAS INJECTED AND FURTHERMORE THREE MONTHS AGO THE PISTON BROKE AND SHE DECIDED BY HERSELF TO SWITCH TO ACTRAPID VIAL. HER FASTING BLOOD GLUCOSE THEN DECREASED TO 0.90 TO 1.50 G/L. EVENT STOP DATE NINETEEN DAYS LATER. RECENTLY HER FASTING PLASMA GLUCOSE LEVEL WAS 1.10 G/L. ADDITIONALLY, ONE MONTH AGO, THE NOVOPEN 3 (LOT NO. 961812) USED FOR INJECTION OF INSULATARD PENFILL FELL DOWN ON THE FLOOR AND THE PUSH-BUTTON WAS SCREWED OFF, BUT THE PT KEPT USING THE DEVICE AND NO ADVERSE EVENT WAS REPORTED (MFR. REPORT #9681821-2007-00009).

    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 RV40064

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other INSULATARD PENFILL (INSULIN HUMAN)| ACTRAPID PENFILL (INSULIN HUMAN)| CLAMOXYL (AMOXICILLIN)| SOLUTION FOR INJECTION, 100 IU/ML| DICLOFENAC| SUSPENSION FOR INJECTION, 100IU/ML