BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 16476881 · Received March 3, 2023

    Report

    Report Number
    9681821-2023-00030
    Event Type
    Injury
    Date Received
    March 3, 2023
    Report Date
    February 14, 2023
    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). CASE DESCRIPTION: STUDY ID: 1706-NOVOCARE PROGRAMME. 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. PATIENT'S HEIGHT: 165 CM. PATIENT'S WEIGHT: 200 KG. PATIENT'S BMI: 73.46189160. THIS SERIOUS SOLICITED REPORT FROM EGYPT WAS REPORTED BY A CONSUMER AS "HYPOGLYCEMIA(HYPOGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE , "HYPERGLYCEMIA(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE , "DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON(DEVICE COMPONENT MALFUNCTION)" WITH AN UNSPECIFIED ONSET DATE , "DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON WITHOUT INSULIN INJECTION(DEVICE FAILURE)" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A 64 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", ACTRAPID (INSULIN HUMAN) (DOSE, FREQUENCY & ROUTE USED-15 IU, BID (15 IU TWICE DAILY BEFORE BREAKFAST AND LUNCH. (TOTAL 30IU)), SUBCUTANEOUS) FROM UNKNOWN START DATE AND ONGOING FOR "DIABETIC PATIENT WITH A STROKE", "HYPERTENSIVE PATIENT WITH A STROKE". CURRENT CONDITION: DIABETES, HYPERTENSIVE. HISTORICAL CONDITION: CEREBROVASCULAR ACCIDENT. CONCOMITANT MEDICATIONS INCLUDED - LANTUS(INSULIN GLARGINE), DIFLUCAN(FLUCONAZOLE), KETOSTERIL((RS)-3 METHYL-2-OXOVALERIANIC ACID CALCIUM, (RS)-3-METHYL-2-OXOBUTYRIC ACID CALCIUM, CALCIUM (RS)-4-METHYL-2-OXOVALERIANAT, CALCIUM 2-OXO-3-PHENYLPROPIONATE, DESMENINOL CALCIUM, HISTIDINE, LYSINE ACETATE, THREONINE, TRYPTOPHAN, L-, TYROSINE), FORTAMIND(CITICOLINE), PROCORALAN(IVABRADINE HYDROCHLORIDE), ZURCAL(PANTOPRAZOLE SODIUM SESQUIHYDRATE), LUSTRAL(SERTRALINE HYDROCHLORIDE), EXAMIDE(TORASEMIDE), KRISTOR, GASTREG, OMEGA3, IRESTAPEX, PREXILAN, ESPOSIDE 75 (NON CODABLE). ON UNKNOWN DATE IN (B)(6) 2023 PATIENT WAS HOSPITALISED FOR 25 DAYS AS BLOOD GLUCOSE LEVELS WERE FLUCTUATING BETWEEN HYPERGLYCEMIA AND HYPOGLYCEMIA THIS IS DUE TO PROBLEM WITH THE PEN AS DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON WITHOUT INSULIN INJECTION AND THAT PEN WAS ALREADY REPLACED WITH ANOTHER ONE. ON UNKNOWN DATE PATIENT BLOOD GLUCOSE LEVEL WAS 42 TO 200 (UNITS WERE NOT REPORTED). BATCH NUMBER WAS REQUESTED. ACTION TAKEN TO ACTRAPID WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "HYPOGLYCEMIA(HYPOGLYCEMIA)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "HYPERGLYCEMIA(HYPERGLYCEMIA)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON(DEVICE COMPONENT MALFUNCTION)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON WITHOUT INSULIN INJECTION(DEVICE FAILURE)" WAS NOT REPORTED. REPORTER'S CAUSALITY (NOVOPEN 4): HYPOGLYCEMIA(HYPOGLYCEMIA) : PROBABLE, HYPERGLYCEMIA(HYPERGLYCEMIA) : PROBABLE, DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON(DEVICE COMPONENT MALFUNCTION) : PROBABLE, DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON WITHOUT INSULIN INJECTION(DEVICE FAILURE) : PROBABLE. COMPANY'S CAUSALITY (NOVOPEN 4): HYPOGLYCEMIA(HYPOGLYCEMIA) : POSSIBLE, HYPERGLYCEMIA(HYPERGLYCEMIA) : POSSIBLE, DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON(DEVICE COMPONENT MALFUNCTION) : POSSIBLE, DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON WITHOUT INSULIN INJECTION(DEVICE FAILURE) : POSSIBLE. REPORTER'S CAUSALITY (ACTRAPID): HYPOGLYCEMIA(HYPOGLYCEMIA) : UNKNOWN, HYPERGLYCEMIA(HYPERGLYCEMIA) : UNKNOWN, DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON(DEVICE COMPONENT MALFUNCTION) : UNKNOWN, DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON WITHOUT INSULIN INJECTION(DEVICE FAILURE) : UNKNOWN, COMPANY'S CAUSALITY (ACTRAPID): HYPOGLYCEMIA(HYPOGLYCEMIA) : POSSIBLE, HYPERGLYCEMIA(HYPERGLYCEMIA) : POSSIBLE, DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON(DEVICE COMPONENT MALFUNCTION) : POSSIBLE, DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON WITHOUT INSULIN INJECTION(DEVICE FAILURE) : POSSIBLE.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SERIOUS SOLICITED REPORT FROM EGYPT WAS REPORTED BY A CONSUMER AS "HYPOGLYCEMIA(HYPOGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE , "HYPERGLYCEMIA(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE , "DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON(DEVICE COMPONENT MALFUNCTION)" WITH AN UNSPECIFIED ONSET DATE , "DOSE COUNTER WAS BACKING TO ZERO AFTER PRESSING ON THE DOSE BUTTON WITHOUT INSULIN INJECTION(DEVICE FAILURE)" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A 64 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", , ACTRAPID (INSULIN HUMAN) FROM UNKNOWN START DATE AND ONGOING FOR "DIABETES", CURRENT CONDITION: DIABETES (MORE THAN 10 YEARS AND TYPE WAS NOT REPORTED), HYPERTENSIVE (MORE THAN 10 YEARS) HISTORICAL CONDITION: STROKE (10 YEARS). CONCOMITANT MEDICATIONS INCLUDED - CRESTOR (ROSUVASTATIN CALCIUM), ERASTAPEX(OLMESARTAN MEDOXOMIL), PRAXILENE(NAFTIDROFURYL OXALATE), ASPOCID(ACETYLSALICYLIC ACID), OMEGA-3 [OMEGA-3 NOS], GAST-REG(TRIMEBUTINE MALEATE). BATCH NUMBERS: NOVOPEN 4, ACTRAPID: REQUESTED. INVESTIGATION RESULT: NOVOPEN® 4 BATCH NUMBER: HVGN351, THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. ACTRAPID® VIAL BATCH NUMBER: 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 RESULT UPDATED, IMDRF CODE ADDED, CONCOMITANT PRODUCTS ( CRESTOR, ERASTAPEX, PRAXILENE, ASPOCIDE 75, OMEGA-3, GAST-REG) WERE UPDATED. SUSPECT PRODUCT ACTRAPID INDICATION HYPERSTENSION REMOVED. REFERENCES INCLUDED: REFERENCE TYPE: E2B COMPANY NUMBER. REFERENCE ID#: (B)(4). REFERENCE NOTES: REFERENCE TYPE: MW 3500A MFR. RPT. # REFERENCE ID#: 9681821-2023-00030. REFERENCE NOTES: MEDWATCH 3500A MFR. REPORT NUMBER. FINAL MANUFACTURER'S COMMENT: 28-MAR-2023: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND IN THE REFERENCE SAMPLE ANALYSIS. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. 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. LONG STANDING MEDICAL CONDITION OF DIABETES MELLITUS, ELDERLY AGE AND POLYPHARMACY ARE RISK FACTORS FOR THE DEVELOPMENT OF HYPERGLYCAEMIA AND HYPOGLYCAEMIA. EVENTS ARE LISTED. THIS SINGLE CASE REPORT IS NOT CONSIDERED TO CHANGE THE CURRENT KNOWLEDGE ON THE SAFETY PROFILE OF ACTRAPID. H3 CONTINUED: EVALUATION SUMMARY NOVOPEN® 4 BATCH NUMBER: HVGN351. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858015 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A HVGN351

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other ASPOCID (ACETYLSALICYLIC ACID)| CRESTOR (ROSUVASTATIN CALCIUM)| DIFLUCAN (FLUCONAZOLE)| ERASTAPEX (OLMESARTAN MEDOXOMIL)| EXAMIDE (TORASEMIDE)| FORTAMIND (CITICOLINE)| GAST-REG (TRIMEBUTINE MALEATE)| IRESTAPEX (TORASEMIDE)| KETOSTERIL| LANTUS (INSULIN GLARGINE)| LUSTRAL (SERTRALINE HYDROCHLORIDE)| OMEGA-3 [OMEGA-3 NOS] (OMEGA-3 [OMEGA-3 NOS])| PRAXILENE (NAFTIDROFURYL OXALATE)| PROCORALAN (IVABRADINE HYDROCHLORIDE)| ZURCAL (PANTOPRAZOLE SODIUM SESQUIHYDRATE)