BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 4102600 · Received September 11, 2014

    Report

    Report Number
    9681821-2014-00037
    Event Type
    Injury
    Date Received
    September 11, 2014
    Report Date
    August 12, 2014
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULT: NAME: NOVOPEN 4, BATCH NUMBER: XUG0755, A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. (B)(4). THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM PENFILL CARTRIDGE. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DURING EXAMINATION/TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE DEVICE WAS TESTED WITH A RANDOM CARTRIDGE AND A NOVO NORDISK NEEDLE WAS MOUNTED. DURING TESTING, IT WAS POSSIBLE TO DELIVER PREPARATION FROM THE CARTRIDGE. NO FAULTS CONCERNING THE PISTON ROD OR PUSH BUTTON WERE OBSERVED. A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. NOVOPEN 3, BATCH: UNK NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE OR BATCH NUMBER AVAILABLE. FINAL MANUFACTURER COMMENT: (B)(4) 2014: NO FAULT WAS FOUND ON THE RETURNED NOVOPEN 4 AND VERY LITTLE INFO REGARDING THE PATIENTS HANDLING OF THE PENS, CO-MORBIDITIES AND CONCOMITANT MEDICATION WERE PRESENT IN THE CASE, IT IS THUS NOT POSSIBLE DEDUCT A CLEAR ROOT-CAUSE FOR THE EXPERIENCED EVENT OR FIND CASES WITH SIMILAR EVENTS AS DESCRIBED IN (B)(4).

    Description of Event or Problem · 1

    INCREASED BLOOD GLUCOSE VALUES [BLOOD GLUCOSE INCREASED]. NOVO PEN DEVICES DIDN'T WORK [DEVICE FAILURE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER AS "INCREASED BLOOD GLUCOSE VALUES" WITH AN UNSPECIFIED ONSET DATE, "NOVOPEN DEVICES DIDN'T WORK" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A (B)(6)-YEAR-OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE), NOVOPEN 3 (INSULIN DELIVERY DEVICE) BOTH FROM UNK START DATE FOR DEVICE THERAPY. PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX: NOT REPORTED. MEDICAL HISTORY INCLUDES DIABETES MELLITUS SINCE 2003. CONCOMITANT PRODUCTS INCLUDED-NOVORAPID (FAST-ACTING INSULIN ASPART), PROTAPHANE (LONG ACTING INSULIN HUMAN). THE PATIENT INJECTED NOVORAPID 6 TIMES PER DAY AND PROTAPHANE 1 TIME PER DAY. ON AN UNK DATE, THE PATIENT EXPERIENCED BLOOD GLUCOSE VALUES (UP TO CIRCA 200 MG/DL) DURING THE USE OF NOVOPEN 4 AND NOVOPEN 3. THE CARE SERVICE HAD BEEN CALLED AND INJECTED THE INSULIN BECAUSE BOTH NOVOPEN DEVICES DIDN'T WORK. THE PISTON RODE OF NOVOPEN 4 WAS FALLEN OFF. THE PUSH BUTTON OF NOVAPEN 3 WAS BLOCKED. ACTION TAKEN TO NOVOPEN 4 AND NOVOPEN 3 WAS NOT REPORTED. THE OVERALL OUTCOME OF THE EVENTS WAS NOT REPORTED. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562386 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S NA XUG0755

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention PROTAPHANE (INSULIN HUMAN)| SOLUTION FOR INJECTION: 100 U/ML| NOVORAPID (INSULIN ASPART)| SUSPENSION FOR INJECTION: 100IU/ML.