BEUDAMED
    FDA Adverse Event Other Summary report: N

    INNOVO

    MDR report key: 327013 · Received April 11, 2001

    Report

    Report Number
    9681821-2001-00009
    Event Type
    Other
    Date Received
    April 11, 2001
    Date of Event
    December 1, 2000
    Report Date
    March 13, 2001
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BLOOD SUGARS DETERIORATED (HYPERGLYCEMIA). CASE DESCRIPTION: A NURSE REPORTED THAT A PATIENT EXPERIENCED HYPERGLYCEMIA. AN INNOVO DEVICE WAS GIVEN TO PATIENT AND FAMILY WHICH THEY STARTED USING IN 2000 AND FROM THAT DATE THE PATIENT'S BLOOD SUGARS RAN ABNORMALLY HIGH DURING THE DAY. THEY STOPPED USING THE DEVICE AFTER TEN DAYS AND PATIENT'S BLOOD SUGARS SETTLED WHEN GOING BACK TO NOVOPEN 1.5. WHEN THE NURSE TESTED THE DEVICE BY DELIVERING 20 IU INTO A PEN CAP IT DID NOT APPEAR TO REACH THE TEST LINE SO SHE DREW UP THE INSULIN USING A SYRINGE AND WAS ONLY ABLE TO DRAW BACK 16 IU. THE CASE HAS BEEN RE-CLASSIFIED FROM NON-SERIOUS TO SERIOUS IN FEBRUARY 2001 DUE TO MEDICAL SIGNIFICANCE. FOLLOW UP INFORMATION RECEIVED IN MARCH 2001. THE REPORTING DIABETES NURSE SPECIALIST STATES IN A LETTER THAT THE SAME DOSE OF INSULIN AND THE SAME DAILY DOSE WERE USED PRIOR TO, DURING AND AFTER THE EVENT. THE LAST HBA1C RECORDED WAS 7.8% IN SEPTEMBER 2000. THERE WAS NO CHANGE TO PATIENT'S ROUTINE AT ALL. MEALS AND ACTIVITY LEVELS WERE THE SAME AS USUAL. THE BLOOD SUGARS WHILST USING THE INNOVO INCREASED BUT WENT BACK TO NORMAL WHEN USING THE 3 ML PEN. NO TREATMENT WAS REQUIRED.

    Description of Event or Problem · 1

    BLOOD SUGARS DETERIORATED (HYPERGLYCEMIA). CASE DESCRIPTION: A NURSE REPORTED THAT A PATIENT EXPERIENCED HYPERGLYCEMIA. AN INNOVO DEVICE WAS GIVEN TO PATIENT AND FAMILY WHICH THEY STARTED USING IN 2000 AND FROM THAT DATE THE PATIENT'S BLOOD SUGARS RAN ABNORMALLY HIGH DURING THE DAY. THEY STOPPED USING THE DEVICE AFTER TEN DAYS AND PATIENT'S BLOOD SUGARS SETTLED WHEN GOING BACK TO NOVOPEN 1.5. WHEN THE NURSE TESTED THE DEVICE BY DELIVERING 20 IU INTO A PEN CAP IT DID NOT APPEAR TO REACH THE TEST LINE SO SHE DREW UP THE INSULIN USING A SYRINGE AND WAS ONLY ABLE TO DRAW BACK 16 IU. THE CASE HAS BEEN RE-CLASSIFIED FROM NON-SERIOUS TO SERIOUS IN FEBRUARY 2001 DUE TO MEDICAL SIGNIFICANCE. FOLLOW UP INFORMATION RECEIVED IN MARCH 2001. THE REPORTING DIABETES NURSE SPECIALIST STATES IN A LETTER THAT THE SAME DOSE OF INSULIN AND THE SAME DAILY DOSE WERE USED PRIOR TO, DURING AND AFTER THE EVENT. THE LAST HBA1C RECORDED WAS 7.8% IN SEPTEMBER 2000. THERE WAS NO CHANGE TO PATIENT'S ROUTINE AT ALL. MEALS AND ACTIVITY LEVELS WERE THE SAME AS USUAL. THE BLOOD SUGARS WHILST USING THE INNOVO INCREASED BUT WENT BACK TO NORMAL WHEN USING THE 3 ML PEN. NO TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16612 INNOVO INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S NA KW40046

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other MIXATARD 10 PENFILL - HM(GE),| INJ. SUSP., 100 IU/ML UNK TO UNK.| 3ML (INSULIN HUMAN, BIOSYNTHETIC),