BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 17036842 · Received June 1, 2023

    Report

    Report Number
    9681821-2023-00080
    Event Type
    Injury
    Date Received
    June 1, 2023
    Report Date
    April 5, 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

    INVESTIGATION RESULTS: NOVOPEN4, BATCH NUMBER: BUG1298. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: INVESTIGATION RESULT ADDED, IMDRF CODE ADDED, RELEVANT FIELDS UPDATED IN EU/CA TAB, AND NARRATIVE UPDATED ACCORDINGLY. REFERENCES INCLUDED: REFERENCE TYPE: E2B LINKED REPORT, REFERENCE ID#: (B)(4), REFERENCE NOTES: SAME PATIENT. FINAL MANUFACTURER'S COMMENT: 30-JUN-2023: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR INVESTIGATION. 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. PATIENT'S UNDERLYING MEDIAL CONDITION OF DIABETES MELLITUS AND MULTIPLE COMORBIDITIES AND CONCOMITANT MEDICATIONS ARE CONFOUNDING FACTORS FOR THE DEVELOPMENT OF HYPERGLYCAEMIA. EVENTS ARE LISTED. THIS SINGLE CASE REPORT IS NOT CONSIDERED TO CHANGE THE CURRENT KNOWLEDGE OF THE SAFETY PROFILE MIXTARD 30HM PENFILL. EVALUATION SUMMARY: NOVOPEN4, BATCH NUMBER: BUG1298 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). HYPERGLYCEMIA (RBS WAS 411 MG/DL AND 512 MG/DL) [HYPERGLYCAEMIA] THE PEN DID NOT INJECT DOSE ACCURATELY DUE TO TECHNICAL ISSUE [DEVICE DELIVERY SYSTEM ISSUE]. CAN'T READ THE LETTERS OF THE BATCH NUMBER, LETTERS ARE SMALL [PRODUCT LABEL ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM EGYPT WAS REPORTED BY A PATIENT FAMILY MEMBER OR FRIEND AS "HYPERGLYCEMIA (RBS WAS 411 MG/DL AND 512 MG/DL)(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE, "THE PEN DID NOT INJECT DOSE ACCURATELY DUE TO TECHNICAL ISSUE(INACCURATE DELIVERY BY DEVICE)" WITH AN UNSPECIFIED ONSET DATE, "CAN'T READ THE LETTERS OF THE BATCH NUMBER, LETTERS ARE SMALL(PRODUCT LABEL TEXT ILLEGIBLE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 62 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE AND ONGOING FOR "DIABETES MELLITUS", MIXTARD 30 HM PENFILL (INSULIN HUMAN) (50 IU, QD (30 U AT BREAKFAST AND 20 U AT LUNCH), SUBCUTANEOUS) FROM UNKNOWN START DATE AND ONGOING FOR "DIABETES MELLITUS". PATIENT'S HEIGHT: 165 CM . PATIENT'S WEIGHT: 80 KG . PATIENT'S BMI: 29.38475670. CURRENT CONDITION: DIABETES MELLITUS SINCE 27 YEARS (TYPE OF DIABETES NOT REPORTED), HYPERTENSION, NEUROPATHY PERIPHERAL, PARKINSON'S DISEASE, VASCULAR, CLOTTING, URINARY RETENTION. HISTORICAL CONDITION: KETOACIDOSIS. PROCEDURE: UNBLOCK ARTERIES OPERATION, AMPUTATION ON 1 TOE OF LEG, AMPUTATION ON SECOND TOE OF LEG, HOSPITALIZED. CONCOMITANT PRODUCTS INCLUDED - PRAXILENE(NAFTIDROFURYL OXALATE), ACHTENON(BIPERIDEN HYDROCHLORIDE), LIBRAX [CHLORDIAZEPOXIDE HYDROCHLORIDE;CLIDINIUM BROMIDE](CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE) ONGOING, ERASTAPEX TRIO(AMLODIPINE BESILATE, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL) ONGOING. MIXTARD PENFILLS USED FROM 10 YEARS. ON AN UNSPECIFIED DATE, THE PATIENT HAD A HYPERGLYCEMIA AS HIS RANDOM BLOOD GLUCOSE LEVEL (BLOOD GLUCOSE) WAS ABOUT 512, 411 AND 277 MG/DL DUE TO A TECHNICAL ISSUE IN HIS NOVOPEN AND THE REPORTER THINKS THAT THE PEN DID NOT INJECT DOSE ACCURATELY. IT WAS REPORTED THAT THE PEN DID NOT INJECT INSULIN NORMALLY SO PEN TRAINING WAS OFFERED, ADJUST ED DOSE COUNTER TO 60 IU AND PRESSED (TWICE ), THE PISTON ROD DID NOT MOVE THEN SHE GOT IT OUT BY HERSELF. THEN BY USING NEWNEEDLE AND PENFILL ADJUSTED THE DOSE COUNTER ON 4IU AND PRESSED, THE PEN INJECTED INSULIN NORMALLY SO THE REPORTER WAS INFORMED THAT IT COULD BE THE NEEDLE THAT WAS BLOCKED SO SHE WAS INFORMED TO CHANGE THE NEEDLE AFTER EVERY INJECTION BUT SHE WASN'T SATISFIED AND WAS OFFERED TO COMPLETE THE PEN TRAINING WITH NOVOFINE NEEDLES BUT SHE WASN'T SATISFIED. THE PATIENT DID NOT USE NOVO NORDISK NEEDLE. PATIENT MENTIONED SHE CAN'T READ THE LETTERS OF THE BATCH NUMBER AND BY CONFIRMATION SHE WAS OLD WOMAN AND COULDN'T READ AS THE LETTERS WERE SMALL AND THEN THE BATCH NUMBER OF NP4 WAS TAKEN AS (BUG1298). BATCH NUMBERS: NOVOPEN 4: BUG1298. MIXTARD 30 HM PENFILL: MR7GA26 . ACTION TAKEN TO MIXTARD 30 HM PENFILL WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "HYPERGLYCEMIA (RBS WAS 411 MG/DL AND 512 MG/DL)(HYPERGLYCEMIA)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "THE PEN DID NOT INJECT DOSE ACCURATELY DUE TO TECHNICAL ISSUE(INACCURATE DELIVERY BY DEVICE)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "CAN'T READ THE LETTERS OF THE BATCH NUMBER, LETTERS ARE SMALL(PRODUCT LABEL TEXT ILLEGIBLE)" WAS NOT REPORTED. REFERENCES INCLUDED: REFERENCE TYPE: E2B LINKED REPORT. REFERENCE ID#: EG-NOVOPROD-1049161. REFERENCE NOTES: SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683077 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A BUG1298

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other ACHTENON (BIPERIDEN HYDROCHLORIDE) ONGOING| ERASTAPEX TRIO ONGOING| LIBRAX ONGOING| PRAXILENE (NAFTIDROFURYL OXALATE) ONGOING