BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVEPEN 4

    MDR report key: 3131788 · Received May 7, 2013

    Report

    Report Number
    9681821-2013-00016
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # 20-986.

    Description of Event or Problem · 1

    THE PISTON ROD WAS MOVING UP AND DOWN AND HE COULD NOT INJECT THE INSULIN [DEVICE MALFUNCTION]. TO EXTRACT THE REMAINING INSULIN WITH A SYRINGE, INJECTED 12 UNITS FROM THAT SYRINGE [WRONG TECHNIQUE IN DRUG USAGE PROCESS]. ([HYPOGLYCEMIC UNCONSCIOUSNESS]). CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT: NO. THIS SERIOUS SPONTANEOUS CASE REPORTED BY A HEALTH CARE PROFESSIONAL (INITIALLY REPORTED BY A CONSUMER) FROM (B)(6), CONCERNS (B)(6) MALE PATIENT WITH DIABETES MELLITUS WHO WAS TREATED WITH LEVEMIR (INSULIN DETEMIR) AND NOVOPEN 4 (INSULIN DELIVERY DEVICE) ON UNKNOWN DATES AND EXPERIENCED "ALMOST UNCONSCIOUSLY, SHE CHECKED HIS BLOOD GLUCOSE LEVEL, DEVICE SHOWED LO" BEGINNING ON (B)(6) 2013, "THE PISTON ROD WAS MOVING UP AND DOWN AND HE COULD NOT INJECT THE INSULIN" BEGINNING ON (B)(6) 2013 AND "DECIDED TO EXTRACT THE REMAINING INSULIN WITH A SYRINGE, INJECTED 12 UNITS FROM THAT SYRINGE" BEGINNING ON (B)(6) 2013. PATIENT'S HEIGHT: 175 CM. MEDICAL HISTORY INCLUDED DIABETES MELLITUS (TYPE UNKNOWN FROM (B)(6) 1997), HEPATOPATHIA, CHRONIC PANCREATITIS, RECTUM TUMOR WITH OPUS, AZOTEMIA, HYPERTONIA AND ANAEMIA. ON (B)(6) 2013, THE PATIENT ADJUSTED THE DOSE AND WANTED TO INJECT THE INSULIN. THE PATIENT NOTED THAT THE PISTON ROD WAS MOVING UP AND DOWN AND HE WAS UNABLE TO INJECT THE INSULIN. HE DECIDED TO EXTRACT THE REMAINING INSULIN WITH A SYRINGE (PREVIOUSLY MARKETED, TODAY NO LONGER AVAILABLE U-40 INSULIN TYPE (1 ML-40U) SYRINGE. THE PATIENT'S USUAL DOES WAS 11 UNITS. THE TYPE OF SYRINGE WAS UNKNOWN. ACCORDING TO THE PATIENT, THERE WERE 24 UNITS IN THE SYRINGE AND HE PRESUMED THAT IT EQUALS WITH THE NORMAL DOSE, SO HE INJECTED 12 UNITS FROM THAT SYRINGE. IN THE MORNING AT 04:30 AM, HIS WIFE SAW THAT THE PATIENT WAS SITTING NEXT TO THE BED, ALMOST UNCONSCIOUSLY, SHE CHECKED HIS BLOOD GLUCOSE LEVEL, THE DEVICE SHOWED: LO. SHE ASSUMED THAT HER HUSBAND WAS SUFFERING A SEVERE HYPOGLYCAEMIA. SHE INJECTED GLUCAGON HYPOKIT (GLUCAGON) INTO THE PATIENT AND GAVE HIM 2 SPOONS OF SUGAR. AT 06:00 AM THE PATIENT BLOOD GLUCOSE LEVEL WAS 3.7 MMOL/L. THE PATIENT WAS NOT HOSPITALIZED AFTER THE EVENT. ON (B)(6) 2013, BLOOD GLUCOSE WAS 2.0 MMOL/L WHEN CHECKED BY THE DIABETOLOGIST DURING MEDICAL EXAMINATION. THE MOST RECENT HBA1C (GLYCOSYLATED HAEMOGLOBIN) AROUND THE TIME OF THE EVENT: 7.0% (FROM (B)(6) 2013). A MEDICAL EXAMINATION WAS PERFORMED BY THE DIABETOLOGIST ON (B)(6) 2013. RESULT WAS REPORTED AS UNKNOWN. ACTION TAKEN TO LEVEMIR WAS REPORTED AS NO CHANGE. ACTION TAKEN TO NOVOPEN 4 WAS NOT REPORTED. THE PATIENT RECOVERED FROM "ALMOST UNCONSCIOUSLY, SHE CHECKED HIS BLOOD GLUCOSE LEVEL, DEVICE SHOWED LO" ON (B)(6) 2013. THE OVERALL OUTCOME OF "DECIDED TO EXTRACT THE REMAINING INSULIN WITH A SYRINGE" AND "THE PISTON ROD WAS MOVING UP AND DOWN AND HE COULD NOT INJECT THE INSULIN" WAS NOT REPORTED. REPORTER COMMENT: REPORTER'S CAUSALITY: PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199994 NOVEPEN 4 INSULIN DELIVERY DEVICE FMI NOVO NORDISK A/S NA YUG1384

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other (TX DATE: 01/14/2011 TO ONGOING)| (TX DATE: 2009 TO ONGOING)| SILEGON (SILYBUM MARIANUM FRUIT)| KREON, 00014701 (PANCREATIN)| LAVESTRA (LOSARTAN POTASSIUM)| (TX DATE: 2010 TO ONGOING)| AMLODIPINE (TX DATE: 2010 TO ONGOING)| FURON, 00032601,(FUROSEMIDE)| (TX DATE: 1997 TO ONGOING)| NEORECORMON (EPOETIN BETA)| HUMULIN R (INSULIN HUMAN),| (TX DATE: 1997 TO ONGOING)| VITAMIN B12, 00056201 (CYANOCOBALAMIN)| (TX DATE: 1997 TO ONGOING)