BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 5125459 · Received October 2, 2015

    Report

    Report Number
    9681821-2015-00029
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    September 6, 2015
    Report Date
    September 8, 2015
    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
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) HYPOGLYCEMIA [HYPOGLYCAEMIA]. TOOK 28 U NOVORAPID IN EVENING INSTEAD OF LEVEMIR 28 U [WRONG DRUG ADMINISTERED]. NOVOPEN4 ARE TOO SIMILAR IN APPEARANCE [DEVICE PHYSICAL PROPERTY ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER AS "TOOK 28 U NOVORAPID IN EVENING INSTEAD OF LEVEMIR 28 U" AND "HYPOGLYCEMIA" BOTH ON (B)(6) 2015 AND "NOVOPEN4 ARE TOO SIMILAR IN APPEARANCE" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A (B)(6) FEMALE PATIENT WHO WAS TREATED WITH NOVORAPID PENFILL (FAST ACTING INSULIN ASPART) AND LEVEMIR PENFILL (INSULIN DETEMIR) BOTH FROM UNKNOWN START DATE (FROM 03 YEARS) AND ONGOING DUE TO "TYPE 2 DIABETES" AND USED NOVOPEN 4 (INSULIN DELIVERY DEVICE) (REPORTED AS NOVOPEN 4 SILVER) FROM UNKNOWN START DATE AND ONGOING DUE TO TYPE 2 DIABETES AND NOVOPEN 4 (INSULIN DELIVERY DEVICE) (REPORTED AS NOVOPEN 4 BLUE) FROM UNKNOWN START DATE AND DUE TO TYPE 2 DIABETES. PATIENT'S HEIGHT, WEIGHT AND BMI (BODY MASS INDEX): NOT REPORTED. MEDICAL HISTORY INCLUDES TYPE 2 DIABETES (SINCE 2003). THE PATIENT WAS TREATED WITH ORAL MEDICATIONS FOR DIABETES AND INSULIN FOR 3 YEARS. TREATMENT OF THE EVENT INCLUDED - GLUCOSE (GLUCOSE) THE PATIENT WAS USING NOVORAPID PENFILL AND LEVEMIR PENFILL IN 3 YEARS. THE PATIENT STARTED USING NOVORAPID PENFILL AND LEVEMIR PENFILL ALONG WITH NOVOPEN 4 SILVER AND NOVOPEN 4 BLUE FROM UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT KEPT BOTH NOVORAPID IN ONE BLUE POUCH AND ONE LEVEMIR IN ANOTHER BLUE POUCH AND BOTH POUCHES WERE KEPT ON THE TABLE BESIDE BED. ON (B)(6) 2015, THE PATIENT MIXED UP THE POUCHES BECAUSE THEY HAVE THE SAME COLOUR, WHICH RESULTED THAT THE PATIENT TOOK 28 U NOVORAPID IN EVENING INSTEAD OF LEVEMIR 28 U. THE BLOOD SUGAR WENT DOWN FROM 8.8 TO 3.2 MMOL/L OVER 45 MINUTES AND THE PATIENT THEN EXPERIENCED HYPOGLYCEMIA. THE PATIENT REQUIRED MEDICAL ASSISTANCE AND WAS HOSPITALIZED. IN HOSPITAL THE PATIENT WAS GIVEN INTRAVENOUS (IV) GLUCOSE AND SOME GLUCOSE TABLETS TO BRING IT UP ALONG WITH SOME FOOD. THE PATIENT RECOVERED FROM THE EVENT. THE PATIENT REMAINED CONSCIOUS DURING THE COURSE OF EVENT. IT WAS REPORTED THAT THE 2 NOVOPEN4 ARE TOO SIMILAR IN APPEARANCE. UPON FOLLOW UP ON (B)(6) 2015, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY DISTRACTIONS AT THE TIME OF MIX-UP. THE PATIENT DID NOT HAVE A WAY TO DIFFERENTIATE THE PENS. HOWEVER NOW SEPARATE LABELS WERE CREATED FOR EACH POUCH AND ON EACH PEN, ONE STATING NIGHT TIME AND THE OTHER STATING DAYTIME. ACTION TAKEN TO NOVORAPID PENFILL, LEVEMIR PENFILL AND BOTH NOVOPEN 4 WAS NOT REPORTED. ON (B)(6) 2015 THE OUTCOME FOR THE EVENT "HYPOGLYCEMIA" AND THE EVENT "TOOK 28 U NOVORAPID IN EVENING INSTEAD OF LEVEMIR 28 U" WAS RECOVERED. ON (B)(6) 2015 THE OUTCOME FOR THE EVENT "NOVOPEN4 ARE TOO SIMILAR IN APPEARANCE" WAS ASSESSED AS RECOVERED, AS NOW EACH PEN HAS DIFFERENT COLOUR. COMPANY COMMENT: THE PATIENT EXPERIENCED HYPOGLYCAEMIA DUE TO THE MIX-UP BETWEEN BOLUS AND BASAL INSULIN. ALL REPORTED EVENTS ARE LISTED EVENTS.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) CASE DESCRIPTION: INVESTIGATION RESULT, NAME: NOVORAPID PENFILL 3 ML, BATCH NUMBER: UNKNOWN, NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. NAME: LEVEMIR PENFILL 3ML, BATCH NUMBER: ER7H638, (B)(4): A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. (B)(4): A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NAME: NOVOPEN 4 SILVER BATCH NUMBER: DSG0083 (B)(4): A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. (B)(4): A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NOVOPEN 4 BLUE, BATCH UNKNOWN, NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: INVESTIGATION RESULTS, MANUFACTURER COMMENT, CAPA COMMENT. COMPANY COMMENT: THE PATIENT EXPERIENCED HYPOGLYCAEMIA DUE TO THE MIX-UP BETWEEN BOLUS AND BASAL INSULIN. ALL REPORTED EVENTS ARE LISTED EVENTS. FINAL MANUFACTURER COMMENT: ON 15-OCT-2015 AS THE DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR INVESTIGATION AND ONLY VERY LIMITED INFORMATION REGARDING THE HANDLING OF SUSPECTED DEVICE IS AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT-CAUSE OF THE EXPERIENCED ADVERSE EVENT AND THUS FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN (B)(4). EVALUATION SUMMARY: NAME: NOVOPEN 4 SILVER, BATCH NUMBER: DSG0083, (B)(4): A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. (B)(4): A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. IF POSSIBLE, PLEASE FORWARD THE SAMPLE(S) IN QUESTION FOR FURTHER INVESTIGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652118 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S N/A DSG0083

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O