BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 19699232 · Received July 9, 2024

    Report

    Report Number
    9681821-2024-00117
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 14, 2024
    Report Date
    June 17, 2024
    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
    BR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CASE DESCRIPTION: ON (B)(6) 2024 THE SERIOUSNESS OF CASE WAS DOWNGRADED FROM SERIOUS TO NON-SERIOUS AS IT WAS CONFIRMED THAT THE PATIENT WAS NOT HOSPITALIZED. THE CASE NO LONGER QUALIFIES FOR EXPEDITED REPORTING. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING (NOT YET SUBMITTED): SERIOUSNESS CRITERIA UNTICKED. EXPECTED DATE OF FOLLOW UP REPORT REMOVED. GXP COMMENT ADDED. NARRATIVE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    EVENT [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) PEN WAS NOT DISPENSING THE MEDICATION [DEVICE FAILURE] PATIENT BLOOD GLUCOSE WAS CLOSE TO 500MG/DL [BLOOD GLUCOSE INCREASED] CASE DESCRIPTION: STUDY ID: (B)(6) STUDY DESCRIPTION: TRIAL TITLE: TO SUPPORT THE PATIENT IN THE BEGINNING OF TREATMENT WITH NOVO NORDISK PRODUCTS FOR DIABETES MELLITUS AND OBESITY. THE PATIENT IS INSTRUCTED ON HOW TO USE, TRANSPORT AND STORE THE PRODUCTS, AND RECEIVES ORIENTATION BY PHONE, SITE OR IN PERSON BY A NURSE. PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX WERE NOT REPORTED. THIS SERIOUS SOLICITED REPORT FROM BRAZIL WAS REPORTED BY A CONSUMER AS "PEN WAS NOT DISPENSING THE MEDICATION(DEVICE FAILURE)" BEGINNING ON (B)(6) 2024 , "PATIENT BLOOD GLUCOSE WAS CLOSE TO 500MG/DL(BLOOD GLUCOSE INCREASED)" BEGINNING ON (B)(6) 2024 AND CONCERNED A 931 MONTHS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS (UNSPECIFIED TYPE)", , NOVOLIN R PENFILL (INSULIN HUMAN) FROM (B)(6) 2024 AND ONGOING FOR "DIABETES MELLITUS (NOT SPECIFIED TYPE)", DOSAGE REGIMENS: NOVOPEN 4: NOVOLIN R PENFILL: ON (B)(6) 2024 TO NOT REPORTED (DOSAGE REGIMEN ONGOING); CURRENT CONDITION: DIABETES MELLITUS(TYPE AND DURATION NOT REPORTED), HEART PROBLEM. ON (B)(6) 2024, PATIENT'S SON PURCHASED A NOVOPEN 4 BLUE PEN, TOGETHER WITH THE DRUG NOVOLIN R PENFIL FOR PATIENT'S USE. ON (B)(6) 2024, THE PATIENT WENT TO THE EMERGENCY ROOM, AS THE BLOOD GLUCOSE(BLOOD GLUCOSE) WAS CLOSE TO 500MG/DL.THE PATIENT STAYED FOR ALMOST 1 FULL DAY IN EMERGENCY ROOM AND LEFT THE EMERGENCY ROOM THE SAME DAY, WHERE PATIENT USED INSULIN (NOT SPECIFIED) AND SERUM(NOT SPECIFIED). PATIENT DID NOT UNDERGO ANY TYPE OF EXAMINATION AND NO MEDICATION WAS PRESCRIBED FOR HOME USE. PATIENT DID NOT FEEL RECOVERED AND DID NOT DISCONTINUED THE TREATMENT. ON (B)(6) 2024, PATIENT'S SON FOUND OUT THAT THE PATIENT'S BLOOD GLUCOSE WAS CLOSE 300 MG/DL AND NOTICED THAT PEN REMAINED AT THE SELECTED DOSAGE AND ONLY THEN FOUND THAT DURING ALL THESE DAYS THE PEN WAS NOT DISPENSING THE MEDICATION. PATIENT USED MORE THAN 20 TYPES OF MEDICATION, BUT WAS UNABLE TO PROVIDE THE NAME, DOSAGE AND INDICATION. NEEDLES(NOT SPECIFIED) ARE NOT REUSED AND WAS NOT KEPT ATTACHED TO THE PEN AFTER APPLICATION. BATCH NUMBERS OF NOVOLIN R PENFILL AND NOVOPEN 4 WERE NOT REPORTED. ACTION TAKEN TO NOVOLIN R PENFILL WAS REPORTED AS NO CHANGE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED FOR ACTRAPID DOESN'T APPLY EVENT REAPPEARED AFTER REINTRODUCTION OF ACTRAPID DOESN'T APPLY THE OUTCOME FOR THE EVENT "PEN WAS NOT DISPENSING THE MEDICATION(DEVICE FAILURE)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "PATIENT BLOOD GLUCOSE WAS CLOSE TO 500MG/DL(BLOOD GLUCOSE INCREASED)" WAS NOT RECOVERED. REPORTER'S CAUSALITY (NOVOPEN 4) - PEN WAS NOT DISPENSING THE MEDICATION(DEVICE FAILURE) : POSSIBLE PATIENT BLOOD GLUCOSE WAS CLOSE TO 500MG/DL(BLOOD GLUCOSE INCREASED) : POSSIBLE COMPANY'S CAUSALITY (NOVOPEN 4) - PEN WAS NOT DISPENSING THE MEDICATION(DEVICE FAILURE) : POSSIBLE PATIENT BLOOD GLUCOSE WAS CLOSE TO 500MG/DL(BLOOD GLUCOSE INCREASED) : POSSIBLE REPORTER'S CAUSALITY (NOVOLIN R PENFILL) - PEN WAS NOT DISPENSING THE MEDICATION(DEVICE FAILURE) : POSSIBLE PATIENT BLOOD GLUCOSE WAS CLOSE TO 500MG/DL(BLOOD GLUCOSE INCREASED) : POSSIBLE COMPANY'S CAUSALITY (NOVOLIN R PENFILL) - PEN WAS NOT DISPENSING THE MEDICATION(DEVICE FAILURE) : POSSIBLE PATIENT BLOOD GLUCOSE WAS CLOSE TO 500MG/DL(BLOOD GLUCOSE INCREASED) : POSSIBLE SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING (NOT YET SUBMITTED): -NO NEW INFOMRATION ADDED. THIS REPORT IS FOR A FOREIGN DEVICE THAT IS ASSESSED AS "SIMILAR" TO US MARKETED NOVOPEN ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497852 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other