BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 14349407 · Received May 10, 2022

    Report

    Report Number
    9681821-2022-00035
    Event Type
    Injury
    Date Received
    May 10, 2022
    Report Date
    April 14, 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

    (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) HYPERGLYCEMIA (500 MG/DL) [HYPERGLYCAEMIA]. PISTON ROD HAS A PROBLEM, SOMETIMES IT WORKS NORMALLY AND OTHER TIMES NOT [DEVICE ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM EGYPT WAS REPORTED BY A CONSUMER AS "HYPERGLYCEMIA (500 MG/DL)(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE, "PISTON ROD HAS A PROBLEM, SOMETIMES IT WORKS NORMALLY AND OTHER TIMES NOT(DEVICE COMPONENT ISSUE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 119 MONTHS OLD MALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "TYPE 1 DIABETES MELLITUS", ACTRAPID PENFILL (INSULIN HUMAN) SOLUTION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - 23 IU (7 U , 10 U , 6 U), SUBCUTANEOUS) (THERAPY DATES - ONGOING) FROM UNKNOWN START DATE AND ONGOING FOR "TYPE 1 DIABETES MELLITUS", PATIENT'S WEIGHT: 40 KG, HEIGHT : 143 -145 CM, BMI NOT REPORTED. CURRENT CONDITION: TYPE 1 DIABETES MELLITUS, VITAMIN D DEFICIENCY,SIGHT PROBLEMS PATIENT HAD A HISTORY OF HOSPITALIZATION (UNSPECIFIED REASON). CONCOMITANT PRODUCTS INCLUDED - TRESIBA FLEXTOUCH U100(INSULIN DEGLUDEC 100 IU/ML) SOLUTION FOR INJECTION, 100 IU/ML ONGOING, BONE CARE [ALFACALCIDOL](ALFACALCIDOL) ONGOING. ON AN UNSPECIFIED DATE, 1 YEAR AND 8 MONTHS AGO PATIENT HAD STARTED TREATMENT WITH ACTRAPID PENFILS AND 1 YEAR AGO HAD STARTED TREATMENT WITH TRESIBA. ON AN UNKNOWN DATE, PATIENT HAD EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE VALUE OF 500 MG/DL. HYPERGLYCEMIA OCCURRED DUE TO THE ISSUES OF THE PISTON ROD, AS THE PEN WAS SOMETIMES WORKING NORMALLY AND OTHER TIMES NOT . COURSE OF TREATMENT AND ACTION TAKEN TO THE PRODUCT WAS NOT REPORTED. BATCH NUMBERS: NOVOPEN 4: JVGT347, ACTRAPID PENFILL: LR77H28. ACTION TAKEN TO NOVOPEN 4 WAS NOT REPORTED. ACTION TAKEN TO ACTRAPID PENFILL WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "HYPERGLYCEMIA (500 MG/DL)(HYPERGLYCEMIA)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "PISTON ROD HAS A PROBLEM, SOMETIMES IT WORKS NORMALLY AND OTHER TIMES NOT(DEVICE COMPONENT ISSUE)" WAS NOT REPORTED.

    Description of Event or Problem · 0

    NAME: NOVOPEN4, BATCH NUMBER: JVGT347. A BATCH RECORD REVIEW WAS FOUND TO BE NORMAL. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. THE BATCH DOCUMENTATION WAS REVIEWED NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. NAME: ACTRAPID PENFILL 3 ML 100IU/ML, BATCH NUMBER: LR77H28 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE LAST SUBMISSION FOLLOWING INFORMATION HAS BEEN ADDED: -INVESTIGATION RESULT UPDATED. -ANNEX B, C, D AND G CODES UPDATED. -NARRATIVE UPDATED ACCORDINGLY//RKSV. FINAL MANUFACTURER'S COMMENT: ON 16MAY2022: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. BATCH TREND DOCUMENTATION REVIEW WAS FOUND TO BE NORMAL. WITH THE AVAILABLE LIMITED INFORMATION, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT CAUSE IN RELATION TO FUNCTIONALITY OF NOVOPEN 4. UNDERLYING DIABETES IS A SIGNIFICANT CONFOUNDING FACTORS WHICH COULD HAVE CONTRIBUTED REPORTED HYPERGLYCAEMIA. COMPANY COMMENT: HYPERGLYCAEMIA IS ASSESSED AS LISTED ACCORDING TO THE NOVO NORDISK CURRENT CCDS IN ACTRAPID. UNDERLYING MEDICAL CONDITION SUCH AS DIABETES MELLITUS IS A SIGNIFICANT CONFOUNDING FACTOR FOR THE DEVELOPMENT OF HYPERGLYCAEMIA. THIS SINGLE CASE REPORT IS NOT CONSIDERED TO CHANGE THE CURRENT KNOWLEDGE OF THE SAFETY PROFILE OF ACTRAPID. H3 CONTINUED: EVALUATION SUMMARY. NAME: NOVOPEN4, BATCH NUMBER: JVGT347. A BATCH RECORD REVIEW WAS FOUND TO BE NORMAL. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997626 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A JVGT347

    Patients

    Seq Age Sex Outcome Treatment
    1 119 MO Male Other BONE CARE [ALFACALCIDOL]| TRESIBA FLEXTOUCH U100