BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 3170138 · Received June 6, 2013

    Report

    Report Number
    9681821-2013-00022
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 16, 2013
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMF
    PMA / PMN Number
    20-986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: NAME: NOVOPEN 4 SILVER, BATCH NUMBER: YUG1134. INV-(B)(4): 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. INV-(B)(4): VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM PENFILL CARTRIDGE. THE RESULT WAS WITHIN ACCEPTABLE LIMITS. DURING EXAMINATION/TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS: LEVEMIR PENFILL 3 ML - 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 YUG 1134. 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 UNKNOWN. NO INVESTIGATION POSSIBLE, BECAUSE NO SAMPLE IS AVAILABLE. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING INFORMATION-BATCH INFORMATION ADDED FOR SUSPECT DEVICE NOVOPEN 4 (YUG1 134), INVESTIGATION RESULTS FOR SUSPECTED PRODUCTS, MANUFACTURERS FINAL COMMENT ON 25-JUN-2013, NARRATIVE UPDATED ACCORDINGLY. FURTHERMORE, A CORRECTION WAS PERFORMED. SINCE LAST SUBMISSION OF THE CASE, THE FOLLOWING HAS BEEN CORRECTED. - SECOND NOVOPEN 4 (BATCH UNKNOWN) ADDED AS SUSPECT DEVICE. FINAL COMMENT FROM THE MANUFACTURER: 25-JUN-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 SPECIFICATIONS. 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 ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    HIGH BLOOD SUGAR READINGS (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 READINGS". IT CONCERNS A MALE PATIENT WITH TYPE 1 DIABETES MELLITUS, WHO WAS TREATED WITH LEVEMIR PENFILL (INSULIN DETEMIR) FROM AN UNKNOWN DATE AND ONGOING, NOVORAPID PENFILL (FAST-ACTING INSULIN ASPART) AN UNKNOWN DATE AND ONGOING, NOVOPEN 4 BLUE (INSULIN DELIVERY DEVICE) AND NOVOPEN 4 SILVER (INSULIN DELIVERY DEVICE) FROM AN UNKNOWN DATE. PATIENT'S HEIGHT: 173 CM. MEDICAL HISTORY INCLUDED TYPE 1 DIABETES MELLITUS (DURATION UNKNOWN). THE PATIENT WAS HOSPITALIZED ON AN UNKNOWN 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 INSULINS 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. REPORTER COMMENT: REPORTER CAUSALITY: POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455091 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S NA YUG1134
    455092 NOVORAPID PENFILL (INSULIN ASPART) SOLUTION FOR INJECTION, 100U/ML ---
    455093 LEVEMIR PENFILL REGIMEN ---
    455094 NOVORAPID PENFILL REGIMEN #2, ---
    455095 NOVORAPID PENFILL REGIMEN #3 ---

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization