BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 3221074 · Received July 3, 2013

    Report

    Report Number
    9681821-2013-00028
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    May 16, 2013
    Manufacturer
    NOVO NORDISK A/S - DEVICE MANUFACTURING AND SOURCI
    Product Code
    FMF
    PMA / PMN Number
    20-986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION POSSIBLE, BECAUSE NO SAMPLE IS AVAILABLE. INVESTIGATION RESULTS: LEVEMIR PENFILL 3ML- BATCH BT60396. A VISUAL EXAMINATION OF THE RECEIVED SAMPLE HAS BEEN PERFORMED. FURTHERMORE, TRENDING ON THE BATCH HAS BEEN PERFORMED. NOTHING ABNORMAL WAS FOUND. NOVORAPID PENFILL 3 ML- BATCH BK70896. A VISUAL EXAMINATION OF THE RECEIVED SAMPLES HAS BEEN PERFORMED. FURTHERMORE, TRENDING ON THE BATCH HAS BEEN PERFORMED. NOTHING ABNORMAL WAS FOUND. NOVOPEN 4 SILVER- BATCH YUG1134. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE DEVICE WAS TESTED WITH A RANDOM CARTRIDGE AND A NOVO NORDISK NEEDLE MOUNTED. THE DOSE SELECTED WAS DELIVERED WITHOUT OBSERVING ANY PROBLEMS. THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM PENFILL CARTRIDGE. THE RESULT WAS WITHIN ACCEPTABLE LIMITS. DURING EXAMINATION AND TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL. NOVOPEN 4 BLUE-BATCH UNK. NO INVESTIGATION POSSIBLE, BECAUSE NO SAMPLE IS AVAILABLE. ON (B)(4) 2013, A CORRECTION WAS PERFORMED. THE FOLLOWING HAS BEEN CORRECTED: SECOND NOVPEN4 (BATCH UNK) ADDED AS SUSPECT DEVICE. FINAL COMMENT FROM THE MFR: (B)(4) 2013: ONE OF THE TWO SUSPECTED NOVOPEN 4 PENS WERE RETURNED TO NOVO NORDISK A/S. THE PEN WAS FOUND TO BE WORKING ACCORDING TO SPECIFICATION. THE OTHER PEN WAS NOT RETURNED TO NOVO NOVO NORDISK A/S AND IT IS THUS NOT POSSIBLE TO DEDUCT A CLEAR ROOT CAUSE FOR THE EXPERIENCED ADVERSE EVENT AS THE DESCRIPTION OF THE PATIENT HANDLING OF THE PENS INDICATE THAT HE DOES NOT DEVIATE FROM THE USER MANUAL FOR THE NOVOPEN 4. IT IS THUS NOT POSSIBLE TO FIND CASES/EVENTS SIMILAR TO (B)(4). REPORTER COMMENT: REPORTER CAUSALITY POSSIBLE.

    Description of Event or Problem · 1

    HIGH BLOOD SUGAR READING [BLOOD GLUCOSE INCREASED]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER FROM (B)(6) AS "HIGH BLOOD SUGAR READING". IT CONCERNS A MALE PATIENT WITH TYPE 1 DIABETES MELLITUS, WHO WAS TREATED WITH LEVEMIR PENFILL (INSULIN DETEMIR) FROM AN UNK DATE AND ONGOING, NOVORAPID PENFILL (FAST-ACTING INSULIN ASPART) AN UNK DATE AND ONGOING, NOVOPEN 4 BLUE (INSULIN DELIVERY DEVICE) AND NOVOPEN 4 SILVER (INSULIN DELIVERY DEVICE) FROM AN UNK DATE. PT'S HEIGHT: (B)(6). MEDICAL HISTORY INCLUDED TYPE 1 DIABETES MELLITUS (DURATION UNK). THE PATIENT WAS HOSPITALIZED ON AN UNK DATE AS HE HAD HIGH BLOOD SUGAR READINGS. THE PATIENT COMPLETED PRIMING SHOT PRIOR TO EACH INJECTION. THE REPORTER DID NOT SEE ANY CRACKS IN EITHER VIALS AND WAS NOT SURE WHICH INSULIN MAY BE CAUSING THE PROBLEM. THE PATIENT ADMINISTERED 10 UNITS OF NOVORAPID (NORMAL DOSAGE IS 7 UNITS) AND 2 HOURS LATER HIS READINGS WERE 18 MMOL/L. THE PARTICULAR BATCH OF BOTH INSULIN WERE STOPPED DUE TO THIS AE. THE HOSPITAL STAFF ADVISED TO DISPOSE OF CURRENT STOCK OF BOTH LEVEMIR AND NOVORAPID AS WELL AS THE 2 PENS. THE PATIENT WAS PROVIDED REPLACEMENT INSULIN AND THERE WAS NO CHANGE TO THE DOSAGE. THE PRODUCT WAS TEMPORARILY STOPPED AND IT WAS BATCH SPECIFIC. THE PATIENT BEGAN USING NEW BATCH OF INSULIN. THE PATIENT'S MOTHER CONFIRMS THAT THERE HAS BEEN NO CHANGE TO HIS DIET. ACTION TAKEN TO LEVEMIR PENFILL, NOVORAPID PENFILL AND NOVOPEN 4 (BLUE AND SILVER) WAS REPORTED AS DRUG DISCONTINUED TEMPORARILY. THE OVERALL OUTCOME OF "HIGH BLOOD SUGAR READINGS" WAS REPORTED AS RECOVERING/RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303495 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S - DEVICE MANUFACTURING AND SOURCI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization