BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3

    MDR report key: 19141738 · Received April 19, 2024

    Report

    Report Number
    9681821-2024-00072
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    April 8, 2024
    Report Date
    April 9, 2024
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    19-938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). SUGAR LEVELS 500 MG/DL AND 692 MG/DL(THIS MORNING) [BLOOD GLUCOSE INCREASED]. NOVOPEN 3 NOT WORKING PROPERLY, THE MEDICINE DID NOT COME OUT [DEVICE FAILURE]. CASE DESCRIPTION: STUDY ID: 831713-NOVOCARE FOR DIABETES. STUDY DESCRIPTION: TRIAL TITLE: THE MAIN OBJECTIVE OF THIS PATIENT SUPPORT PROGRAMME IS TO PROVIDE EDUCATION, INFORMATION AND TRAINING FOR PATIENTS WITH DIABETES MELLITUS (TYPE 1, TYPE 2 AND DIABETES IN PREGNANCY), WHO HAVE ALREADY BEEN PRESCRIBED BY THEIR TREATING HEALTH CARE PROFESSIONAL (HCP) WITH NOVO NORDISK (NN) PRODUCTS OF INSULIN, LIRAGLUTIDE 0.6-1.8MG FOR TYPE 2 DIABETES AND GLUCAGEN. PATIENTS SHALL BE PROVIDED WITH FULL EDUCATION, INCLUDING THE TECHNICAL USE AND HANDLING OF NN DEVICES (PENS AND NEEDLES) WITH AN OBJECTIVE TO BE SUPPORTED DURING THEIR FIRST STEPS IN THEIR TREATMENT AND TO HAVE AN IMPROVED DIABETES CONTROL AND QUALITY OF LIFE. PATIENTS WITH TYPE 2 DIABETES MELLITUS, WHO HAVE ALREADY BEEN PRESCRIBED BY THEIR TREATING HCP WITH ONCE WEEKLY GLP-1 INHIBITOR SEMAGLUTIDE (OZEMPIC), WITH A PURPOSE TO ENHANCE THE EDUCATION OF THE PATIENTS ON THEIR DISEASE, THROUGH PEN TRAINING, TO IMPROVE DIABETES CONTROL AND PATIENT'S QUALITY OF LIFE, THROUGH NUTRITIONAL ADVICE AND TO SUPPORT TREATMENT ADHERENCE AND COMPLIANCE ON WITH THEIR PRESCRIBED THERAPY. FINALLY, UNDER THE SCOPE OF THE PROGRAM THE PROVIDER MUST UNDERTAKE THE PROVISION PHARMACEUTICAL COMPLIANCE AND ANY PHARMACOVIGILANCE SERVICE. THIS SERIOUS SOLICITED REPORT FROM GREECE WAS REPORTED BY A PATIENT AS "SUGAR LEVELS 500 MG/DL AND 692 MG/DL(THIS MORNING)(BLOOD SUGAR INCREASED)" BEGINNING ON (B)(6) 2024 , "NOVOPEN 3 NOT WORKING PROPERLY, THE MEDICINE DID NOT COME OUT(DEVICE FAILURE)" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A 78 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN 3 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DIABETES TYPE 2", PENMIX 30 PENFILL (DOSE, FREQUENCY & ROUTE USED-77 IU, QD(14IU IN THE MORNING,18 IU IN THE EVENING, 35 IU AT NIGHT), SUBCUTANEOUS) (INSULIN HUMAN, INSULIN ISOPHANE) FROM 1982 AND ONGOING FOR "DIABETES TYPE 2". DOSAGE REGIMENS: NOVOPEN 3: PENMIX 30 PENFILL: -1982 TO NOT REPORTED (DOSAGE REGIMEN ONGOING); CURRENT CONDITION: DIABETES TYPE 2(DURATION NOT REPORTED) ON (B)(6) 2024, PATIENT'S BLOOD SUGAR(BLOOD GLUCOSE) WAS FOUND TO BE 500MG/DL AT NOON AND THAT NIGHT PATIENT HAD 259MG/DL. ON AN UNKNOWN DATE, THIS MORNING PATIENT HAD 692 MG/DL. NOVOPEN 3 IS NOT WORKING PROPERLY. IN PARTICULAR, PATIENT MENTIONED THAT IN THE LAST FEW DAYS THE BUTTON WAS PRESSED VERY EASILY, BUT THE MEDICINE DID NOT COME OUT. BATCH NUMBER OF NOVOPEN 3 AND PENMIX 30 PENFILL WAS NOT REPORTED ACTION TAKEN TO PENMIX 30 PENFILL WAS REPORTED AS NO CHANGE. THE OUTCOME FOR THE EVENT "SUGAR LEVELS 500 MG/DL AND 692 MG/DL(THIS MORNING)(BLOOD SUGAR INCREASED)" WAS RECOVERING/RESOLVING. THE OUTCOME FOR THE EVENT "NOVOPEN 3 NOT WORKING PROPERLY, THE MEDICINE DID NOT COME OUT(DEVICE FAILURE)" WAS NOT REPORTED. REPORTER'S CAUSALITY (NOVOPEN 3) - SUGAR LEVELS 500 MG/DL AND 692 MG/DL(THIS MORNING)(BLOOD SUGAR INCREASED) : PROBABLE NOVOPEN 3 NOT WORKING PROPERLY, THE MEDICINE DID NOT COME OUT(DEVICE FAILURE) : UNKNOWN COMPANY'S CAUSALITY (NOVOPEN 3) - SUGAR LEVELS 500 MG/DL AND 692 MG/DL(THIS MORNING)(BLOOD SUGAR INCREASED) : POSSIBLE NOVOPEN 3 NOT WORKING PROPERLY, THE MEDICINE DID NOT COME OUT(DEVICE FAILURE) : POSSIBLE REPORTER'S CAUSALITY (PENMIX 30 PENFILL) - SUGAR LEVELS 500 MG/DL AND 692 MG/DL(THIS MORNING)(BLOOD SUGAR INCREASED) : UNLIKELY NOVOPEN 3 NOT WORKING PROPERLY, THE MEDICINE DID NOT COME OUT(DEVICE FAILURE) : UNKNOWN COMPANY'S CAUSALITY (PENMIX 30 PENFILL) - SUGAR LEVELS 500 MG/DL AND 692 MG/DL(THIS MORNING)(BLOOD SUGAR INCREASED) : POSSIBLE NOVOPEN 3 NOT WORKING PROPERLY, THE MEDICINE DID NOT COME OUT(DEVICE FAILURE) : POSSIBLE PRELIMINARY MANUFACTURER'S COMMENT: 17-APR-2024: THE SUSPECTED DEVICE NOVOPEN 3 AND SUSPECTED PRODUCT PENMIX 30 PENFILL HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO CONCLUSION REACHED. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? DOESN'T APPLY EVENT REAPPEARED AFTER REINTRODUCTION? DOESN'T APPLY.

    Description of Event or Problem · 0

    CASE DESCRIPTION: PATIENT'S HEIGHT: 160 CM. PATIENT'S WEIGHT: 110 KG. PATIENT'S BMI: 42.968750. CURRENT CONDITION: DIABETES TYPE 2 (DURATION NOT REPORTED), CRAMPS, PAIN, PROBLEM IN HEART, STOMACH ACHE, MELANCHOLY. CONCOMITANT MEDICATIONS INCLUDED - TROFOCARD(MAGNESIUM ASPARTATE HYDROCHLORIDE), XARELTO(RIVAROXABAN), LIPIDIL(FENOFIBRATE), LOSEC [OMEPRAZOLE](OMEPRAZOLE), LASIX [FUROSEMIDE](FUROSEMIDE), ENTACT(ESCITALOPRAM OXALATE), COAPROVEL(HYDROCHLOROTHIAZIDE, IRBESARTAN), T4(LEVOTHYROXINE SODIUM), NEURONTIN USED FOR PAIN, 800 MG, QD WAS NON-CODABLE. PATIENT REPORTED NOT HAVING A PROPER DIET AND CONSUMPTION OF FATTY FOODS ALSO AS THE REASON FOR UNEXPLAINED INCREASE IN BLOOD GLUCOSE LEVELS. INVESTIGATION RESULT: NOVOPEN 3 - BATCH UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. MIXTARD 30 PENFILL 100 IU/ML 3 ML 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: -MALFUNCTION WAS CHANGED TO NO. -DEVICE ADDENDUM WAS UPDATED(BCDG CODES). -EU/CA TAB WAS UPDATED. -PATIENT HEIGHT AND WEIGHT ADDED. -MEDICAL HISTORY UPDATED. -CONCOMITANT MEDICATIONS ADDED. -TREATMENT RECEIVED FOR BLOOD GLUCOSE INCREASED UPDATED TO NO. -NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: 06-JUN-2024: THE SUSPECTED DEVICE NOVOPEN 3 AND SUSPECTED PRODUCT PENMIX 30 PENFILL HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. BATCH NUMBER OF THE DEVICE UNAVAILABLE DESPITE REPEATED EFFORTS TO FIND THE SAME. NO BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS PERFORMED. NO OTHER CONFOUNDING FACTORS IDENTIFIED. 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 3. PATIENT'S UNDERLYING MEDICAL CONDITION OF TYPE 2 DIABETES MELLITUS, ELDERLY AGE (78 YEARS) AND MORBID OBESITY ARE SIGINIFICANT RISK 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 OF MIXTARD 300 PENFILL. H3 CONTINUED: EVALUATION SUMMARY: NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823844 NOVOPEN 3 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other COAPROVEL (HYDROCHLOROTHIAZIDE, IRBESARTAN).| ENTACT (ESCITALOPRAM OXALATE).| LASIX [FUROSEMIDE] (FUROSEMIDE).| LIPIDIL (FENOFIBRATE).| LOSEC [OMEPRAZOLE] (OMEPRAZOLE).| T4 (LEVOTHYROXINE SODIUM).| TROFOCARD (MAGNESIUM ASPARTATE HYDROCHLORIDE).| XARELTO (RIVAROXABAN).