BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 14889625 · Received July 1, 2022

    Report

    Report Number
    9681821-2022-00056
    Event Type
    Injury
    Date Received
    July 1, 2022
    Report Date
    May 28, 2022
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    20-986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) POSSIBLE MALFUNCTIONING OF THE DEVICE [DEVICE MALFUNCTION] BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL [DIABETES MELLITUS INADEQUATE CONTROL] PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS) [DIABETIC KETOACIDOSIS] CASE DESCRIPTION: STUDY ID: 1706-NOVOCARE PROGRAMME . STUDY DESCRIPTION: MAIN OBJECTIVE OF THE PROGRAMME IS TO HELP PATIENTS TO UNDERSTAND THEIR DIABETES AND MAINTAIN NORMAL LIFE THROUGH QUALIFIED EDUCATORS WHO OFFER SIMPLE AND PRACTICAL INFORMATION DIRECTLY TO THE PATIENTS AND ALSO, TRAIN PATIENTS ON HOW TO USE THEIR INSULIN DEVICES AND NEEDLES ETC. PATIENT'S HEIGHT: 162 CM. PATIENT'S WEIGHT: 72 KG. PATIENT'S BMI: 27.43484220. THIS SERIOUS SOLICITED REPORT FROM (B)(6) WAS REPORTED BY A CONSUMER AS "POSSIBLE MALFUNCTIONING OF THE DEVICE(DEVICE MALFUNCTION)" WITH AN UNSPECIFIED ONSET DATE , "PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS)(DIABETIC KETOACIDOSIS)" BEGINNING ON (B)(6) 2022, "BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL(LOSS OF CONTROL OF BLOOD SUGAR)" BEGINNING ON (B)(6) 2022 AND CONCERNED A MALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", , NOVORAPID PENFILL (INSULIN ASPART) SOLUTION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - 10/12U MORNING, 8/10U NIGHT, UNKNOWN) FROM UNKNOWN START DATE AND ONGOING FOR "DIABETES MELLITUS", , ACTRAPID PENFILL (INSULIN HUMAN) SOLUTION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - 15U MORNING AND 10/12U NIGHT, UNKNOWN) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", CURRENT CONDITION: DIABETES MELLITUS (SINCE 9 YEARS AGO). CONCOMITANT MEDICATIONS INCLUDED - LANTUS(INSULIN GLARGINE). ABOUT 10 DAYS AGO IN (B)(6) 2022, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS HIGH AS IT REACHED ABOVE 500 AND HE SUFFERED FROM KETOACIDOSIS. IT WAS ADDED THAT A POSSIBLE MALFUNCTIONING OF THE DEVICE COULD HAVE CONTRIBUTED TO THE PATIENT'S KETOACIDOSIS. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED BLOOD GLUCOSE LEVELS OF 320MG/DL IN THE MORNING AND HE TOOK 20U BEFORE BREAKFAST AND AFTER EATING HIS BLOOD GLUCOSE LEVELS WAS 203MG/DL AND BEFORE LUNCH HE TOOK 8U AND AFTER EATING AND BLOOD GLUCOSE LEVELS WAS 312MG/DL FOR KETOACIDOSIS. SINCE AN UNSPECIFIED DATE, THE PATIENT'S BLOOD GLUCOSE WAS UNCONTROLLED (HYPERGLYCEMIA 300-400MG/DL AND HYPOGLYCEMIA 40-60MG/DL) DURING USING ACTRAPID PENFILL AS ACTRAPID START DATE WAS FROM 9 YEARS AGO AND STOP DATE WAS FROM AROUND 4 MONTHS. BATCH NUMBER OF NOVOPEN 4 WAS REQUESTED. BATCH NUMBER NOVORAPID PENFILL: LR7BL81, LR7BL81; ACTRAPID PENFILL: LR78K45; NOVOPEN 4: REQUESTED. ACTION TAKEN TO NOVOPEN 4 WAS NOT REPORTED ACTION TAKEN TO NOVORAPID PENFILL WAS NOT REPORTED. ACTION TAKEN TO ACTRAPID PENFILL WAS REPORTED AS PRODUCT DISCONTINUED DUE TO ADVERSE EVENT. THE OUTCOME FOR THE EVENT "POSSIBLE MALFUNCTIONING OF THE DEVICE(DEVICE MALFUNCTION)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS)(DIABETIC KETOACIDOSIS)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL(LOSS OF CONTROL OF BLOOD SUGAR)" WAS NOT RECOVERED. REPORTER'S CAUSALITY (NOVOPEN 4) - POSSIBLE MALFUNCTIONING OF THE DEVICE(DEVICE MALFUNCTION) : UNKNOWN . PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS)(DIABETIC KETOACIDOSIS) : UNLIKELY. BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL(LOSS OF CONTROL OF BLOOD SUGAR) : UNKNOWN. COMPANY'S CAUSALITY (NOVOPEN 4) - POSSIBLE MALFUNCTIONING OF THE DEVICE(DEVICE MALFUNCTION) : POSSIBLE. PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS)(DIABETIC KETOACIDOSIS) : UNLIKELY. BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL(LOSS OF CONTROL OF BLOOD SUGAR) : POSSIBLE. REPORTER'S CAUSALITY (NOVORAPID PENFILL) - POSSIBLE MALFUNCTIONING OF THE DEVICE(DEVICE MALFUNCTION) : UNKNOWN . PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS)(DIABETIC KETOACIDOSIS) : UNLIKELY. BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL(LOSS OF CONTROL OF BLOOD SUGAR) : UNLIKELY. COMPANY'S CAUSALITY (NOVORAPID PENFILL) - POSSIBLE MALFUNCTIONING OF THE DEVICE(DEVICE MALFUNCTION) : POSSIBLE. PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS)(DIABETIC KETOACIDOSIS) : UNLIKELY. BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL(LOSS OF CONTROL OF BLOOD SUGAR) : UNLIKELY . REPORTER'S CAUSALITY (ACTRAPID PENFILL) - POSSIBLE MALFUNCTIONING OF THE DEVICE(DEVICE MALFUNCTION) : UNKNOWN. PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS)(DIABETIC KETOACIDOSIS) : UNKNOWN . BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL(LOSS OF CONTROL OF BLOOD SUGAR) : UNLIKELY . COMPANY'S CAUSALITY (ACTRAPID PENFILL) - POSSIBLE MALFUNCTIONING OF THE DEVICE(DEVICE MALFUNCTION) : POSSIBLE . PATIENT'S BGL WAS HIGH AS IT REACHED ABOVE 500 AND SUFFERED FROM KETOACIDOSIS (DIABETES MELLITUS)(DIABETIC KETOACIDOSIS) : UNLIKELY . BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL(LOSS OF CONTROL OF BLOOD SUGAR) : UNLIKELY. SINCE LAST SUBMISSION, CASE WAS UPDATED WITH THE FOLLOWING: NOVOPEN 4 ADDED AS SUSPECT. EVENT OF DEVICE MALFUNCTION ADDED SUSPECT PRODUCT ACTRAPID ADDED . EVENT "BLOOD GLUCOSE LEVEL WAS UNCONTROLLED DURING USING ACTRAPID PENFILL" ADDED. REPORTER CAUSALITY ADDED. LABORATORY DATA ADDED. PATIENT DETAILS UPDATED. MEDICAL HISTORY DURATION UPDATED. DOSAGE DETAILS OF SUSPECTAND CONCMITANT ADDED REPORTER COMMENT UPDATED. NARRATIVE UPDATED ACCORDINGLY. COMPANY COMMENT: DIABETIC KETOACIDOSIS AND DIABETES MELLITUS INADEQUATE CONTROL ARE ASSESSED AS LISTED EVENT ACCORDING TO THE NOVO NORDISK CURRENT CCDS ON NOVORAPID AND ACTRAPID. WITH AVAILABLE LIMITED INFORMATION, POOR GLYCAEMIC CONTROL AND DIABETIC KETOACIDOSIS COULD BE ATTRIBUTED TO POOR ADHERENCE TO INSULIN DOSING REGIMEN, REDUCED INSULIN DOSING AFTER CHANGING FROM ACTRAPID TO NOVORAPID, AND POOR DIETARY HABIT AS PATIENT ATE TOO MUCH JUST BEFORE THE ONSET OF HYPERGLYCAEMIA AND DIABETIC KETOACIDOSIS. WITH THE AVAILABLE INFORMATION AND CONSIDERING THE PHARMACOLOGICAL NATURE OF SUSPECT PRODUCT, DIABETIC KETOACIDOSIS IS ASSESSED AS UNLIKELY RELATED TO NOVORAPID AND ACTRAPID. THIS SINGLE CASE REPORT IS NOT CONSIDERED TO CHANGE THE CURRENT KNOWLEDGE OF THE SAFETY PROFILE OF NOVORAPID. PRELIMINARY MANUFACTURER'S COMMENT: 23-JUN-2022: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO CONCLUSION IS REACHED. POOR GLYCAEMIC CONTROL AND DIABETIC KETOACIDOSIS COULD BE ATTRIBUTED TO POOR ADHERENCE TO INSULIN DOSING REGIMEN, REDUCED INSULIN DOSING AFTER CHANGING FROM ACTRAPID TO NOVORAPID, AND POOR DIETARY HABIT. REPORTER COMMENT: NO HISTORY OF DIABETES COMPLICATIONS. NO INJECTION IN SKIN AREA WITH LUMPS. NO EXERCISES BUT HE ATE TOO MUCH IN HIS MEALS BEFORE SUFFERING FROM HYPERGLYCEMIA ABOVE 500 MG/DL AND KETOACIDOSIS. NO CO-EXISTING CONDITIONS OR CONCOMITANT MEDICATIONS LEADING TO INCREASED INSULIN REQUIREMENTS. NO MEDICAL HISTORY. ADDITIONAL DOSAGE REGIMENS SUSPECT PRODUCT 2. DOSE, FREQUENCY & ROUTE USED 3. THERAPY DATES (IF UNKNOWN, GIVE DURATION) 6. LOT # 7. EXP. DATE. #1 NOVORAPID PENFILL 3.0 ML REGIMEN # 2 3-4 DAYS THE DOSE BECOME 24U-24U-17U, UNKNOWN ONGOING LR7BL81 03/--/2024.

    Description of Event or Problem · 0

    CASE DESCRIPTION: STUDY DESCRIPTION: TRIAL TITLE: MAIN OBJECTIVE OF THE PROGRAMME IS TO HELP PATIENTS TO UNDERSTAND THEIR DIABETES AND MAINTAIN NORMAL LIFE THROUGH QUALIFIED EDUCATORS WHO OFFER SIMPLE AND PRACTICAL INFORMATION DIRECTLY TO THE PATIENTS AND ALSO, TRAIN PATIENTS ON HOW TO USE THEIR INSULIN DEVICES AND NEEDLES ETC. BATCH NUMBER OF NOVOPEN 4 WAS UNAVAILABLE ACTION TAKEN TO ACTRAPID PENFILL WAS REPORTED AS PRODUCT DISCONTINUED DUE TO AE. INVESTIGATION RESULTS OF NOVOPEN 4: NOVOPEN 4, BATCH NUMBER : UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. INVESTIGATION RESULTS OF NOVORAPID PENFILL: NOVORAPID PENFILL 3 ML 100IU/ML, BATCH NUMBER: LR7BL81 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. INVESTIGATION RESULTS OF ACTRAPID PENFILL: ACTRAPID PENFILL 3 ML 100IU/ML, BATCH NUMBER : LR78K45 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -INVESTIGATION RESULTS UPDATED FOR SUSPECTS NOVOPEN 4, NOVORAPID PENFILL AND ACTRAPID PENFILL -EU/CA TAB UPDATED IN NOVOPEN 4 -IMDRF CODES UPDATED WITH B,C,D,G CODES FOR SUSPECT NOVOPEN 4 -NARRATIVE UPDATED ACCORDINGLY. COMPANY COMMENT: DIABETIC KETOACIDOSIS AND DIABETES MELLITUS INADEQUATE CONTROL ARE ASSESSED AS LISTED EVENT ACCORDING TO THE NOVO NORDISK CURRENT CCDS ON NOVORAPID AND ACTRAPID. WITH AVAILABLE LIMITED INFORMATION, POOR GLYCAEMIC CONTROL AND DIABETIC KETOACIDOSIS COULD BE ATTRIBUTED TO POOR ADHERENCE TO INSULIN DOSING REGIMEN, REDUCED INSULIN DOSING AFTER CHANGING FROM ACTRAPID TO NOVORAPID, AND POOR DIETARY HABIT AS PATIENT ATE TOO MUCH JUST BEFORE THE ONSET OF HYPERGLYCAEMIA AND DIABETIC KETOACIDOSIS. WITH THE AVAILABLE INFORMATION AND CONSIDERING THE PHARMACOLOGICAL NATURE OF SUSPECT PRODUCT, DIABETIC KETOACIDOSIS IS ASSESSED AS UNLIKELY RELATED TO NOVORAPID AND ACTRAPID. THIS SINGLE CASE REPORT IS NOT CONSIDERED TO CHANGE THE CURRENT KNOWLEDGE OF THE SAFETY PROFILE OF NOVORAPID AND ACTRAPID. FINAL MANUFACTURER'S COMMENT: 19-JUL-2022: THE SUSPECTED DEVICE (NOVOPEN 4) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR THE INVESTIGATION. BATCH NUMBER OF DEVICES IS NOT AVAILABLE DESPITE REPEATED EFFORTS FIND THE SAME. BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS WAS NOT PERFORMED. WITH THE AVAILABLE LIMITED INFORMATION REGARDING THE HANDLING OF THE SUSPECTED DEVICE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT CAUSE IN RELATION TO FUNCTIONALITY OF NOVOPEN 4. POOR GLYCAEMIC CONTROL AND DIABETIC KETOACIDOSIS COULD BE ATTRIBUTED TO POOR ADHERENCE TO INSULIN DOSING REGIMEN, REDUCED INSULIN DOSING AFTER CHANGING FROM ACTRAPID TO NOVORAPID, AND POOR DIETARY HABIT. CONTINUED: EVALUATION SUMMARY NOVOPEN 4, BATCH NUMBER : UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231990 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other LANTUS (INSULIN GLARGINE)