BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOPEN 3

    MDR report key: 1179123 · Received September 26, 2008

    Report

    Report Number
    9681821-2008-00039
    Event Type
    Other
    Date Received
    September 26, 2008
    Report Date
    August 28, 2008
    Manufacturer
    NOVO NORDISK A/S - DEVICE MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    19-938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOW BLOOD SUGAR [BLOOD GLUCOSE DECREASED], BLURRY VISION [VISION BLURRED]. CASE DESCRIPTION: MEDICAL DEVICE INFORMATION: NOVOPEN 3 CLASS ILB. THIS SPONTANEOUS REPORT, REPORTED BY A CONSUMER, RECEIVED FROM THE UNITED STATES AND REPORTED AS "LOW BLOOD SUGAR AND BLURRY VISION" CONCERNS A (B) (6) MALE PATIENT TREATED WITH NOVOLOG MIX 70/30 PENFILL (DUAL ACTING INSULIN ASPART) FROM 2003 TO ONGOING, NOVOLIN N PENFILL (INSULIN HUMAN) FROM 2003 TO ONGOING AND A NOVOPEN3 FOR "INSULIN REQUIRING TYPE II DIABETES MELLITUS." MEDICAL HISTORY INCLUDED BACK INJURY OF SPINAL DISC BUILDING AND UNSPECIFIED BACK SURGERY. IN (B) (6) 2006, A CONSUMER WAS PREPARING FOR OUTPATIENT BACK SURGERY. IN THE PREPARATION ROOM, HIS BLOOD GLUCOSE LEVEL WAS 20MG/DL. SUBSEQUENTLY, HE WAS GIVEN SUGAR WATER INTRAVENOUSLY TO TREAT HIS BLOOD GLUCOSE LEVEL. HE REPORTED THAT THE NEEDLE INSERTED INTO HIS ARM WAS NOT LARGE ENOUGH TO ADMINISTER SUGAR WATER AND AS A RESULT A VEIN RUPTURED. AFTER THE SURGERY WAS PERFORMED, HIS BLOOD GLUCOSE LEVEL NORMALIZED TO 80-90 MG/DL AND WAS RELEASED THAT SAME DAY. HE STATED THAT HE HAS EXPERIENCED LOW FASTING GLUCOSE BETWEEN 40-60 MG/DL INTERMITTENTLY. HE STATED THAT THE INSULIN ACTS TOO QUICKLY AND HE WAKES UP WITH HYPOGLYCEMIA, ESPECIALLY WHEN HE EATS LESS. HE ALSO REPORTED THAT HE HAS EXPERIENCED BLURRY VISION ON OCCASION. THE OVERALL OUTCOME WAS REPORTED AS 'NOT RECOVERED'. 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 - DEVICE MEDICAL SYSTEMS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention