BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 15277650 · Received August 23, 2022

    Report

    Report Number
    9681821-2022-00069
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    July 15, 2022
    Report Date
    July 28, 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

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). PEN DID NOT EJECT THE DOSE CORRECTLY [INCORRECT DOSE ADMINISTERED BY DEVICE]. CARTRIDGE WAS BROKEN [PRODUCT PHYSICAL ISSUE]. HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL [HYPERGLYCAEMIA]. 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. THIS SERIOUS SOLICITED REPORT FROM EGYPT WAS REPORTED BY A CONSUMER AS "HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL (HYPERGLYCEMIA)" BEGINNING ON (B)(6) 2022, "PEN DID NOT EJECT THE DOSE CORRECTLY (INCORRECT DOSE ADMINISTERED BY DEVICE)" WITH AN UNSPECIFIED ONSET DATE, "CARTRIDGE WAS BROKEN(CRACKED PRODUCT)" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A 11 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS (RAISE IN BLOOD LEVELS)", NOVORAPID PENFILL (INSULIN ASPART) SOLUTION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - 21 IU, QD (6,10,5 IU TID), SUBCUTANEOUS) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS (RAISE IN BLOOD LEVELS)". THE PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX (BMI) WERE NOT REPORTED. CURRENT CONDITION: DIABETES MELLITUS. CONCOMITANT MEDICATIONS INCLUDED - TRESIBA FLEXTOUCH U100(INSULIN DEGLUDEC 100 IU/ML) SOLUTION FOR INJECTION, 100 IU/ML. ON (B)(6) 2022, THE NOVOPEN 4 DID NOT EJECT THE DOSE CORRECTLY AND CAUSED HYPERGLYCEMIA WITH THE BLOOD GLUCOSE LEVELS OF 590 MG/DL. IT WAS ALSO FOUND THAT THE NOVORAPID PENFILL CARTRIDGE WAS BROKEN. IT WAS REPORTED THAT WHEN THE NOVOPEN 4 WAS TESTED WITH A NEW CARTRIDGE AND IT WAS CALIBRATED AND EJECTED THE DOSE CORRECTLY. ON (B)(6) 2022,THE EVENT OF HYPERGLYCEMIA LASTED ONLY FOR 4 HOURS AND WAS RECOVERED. BATCH NUMBERS: NOVOPEN 4: NOT REPORTED. NOVORAPID PENFILL: LR7BH31, ASKU. ACTION TAKEN TO NOVORAPID PENFILL AND NOVOPEN WAS NOT REPORTED. ON (B)(6) 2022 THE OUTCOME FOR THE EVENT "HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL (HYPERGLYCEMIA)" WAS RECOVERED. THE OUTCOME FOR THE EVENT "PEN DID NOT EJECT THE DOSE CORRECTLY(INCORRECT DOSE ADMINISTERED BY DEVICE)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "CARTRIDGE WAS BROKEN (CRACKED PRODUCT)" WAS NOT REPORTED. REPORTER'S CAUSALITY (NOVOPEN 4) - HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL (HYPERGLYCEMIA) : UNKNOWN. PEN DID NOT EJECT THE DOSE CORRECTLY (INCORRECT DOSE ADMINISTERED BY DEVICE) : UNKNOWN. CARTRIDGE WAS BROKEN (CRACKED PRODUCT) : UNKNOWN. COMPANY'S CAUSALITY (NOVOPEN 4) - HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/D L (HYPERGLYCEMIA) : POSSIBLE. PEN DID NOT EJECT THE DOSE CORRECTLY (INCORRECT DOSE ADMINISTERED BY DEVICE) : POSSIBLE. CARTRIDGE WAS BROKEN (CRACKED PRODUCT) : POSSIBLE. REPORTER'S CAUSALITY (NOVORAPID PENFILL) - HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL (HYPERGLYCEMIA) : UNKNOWN. PEN DID NOT EJECT THE DOSE CORRECTLY (INCORRECT DOSE ADMINISTERED BY DEVICE) : UNKNOWN. CARTRIDGE WAS BROKEN (CRACKED PRODUCT) : UNKNOWN. COMPANY'S CAUSALITY (NOVORAPID PENFILL) - HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL(HYPERGLYCEMIA) : UNLIKELY. PEN DID NOT EJECT THE DOSE CORRECTLY(INCORRECT DOSE ADMINISTERED BY DEVICE) : POSSIBLE. CARTRIDGE WAS BROKEN (CRACKED PRODUCT) : POSSIBLE. ADDITIONAL DOSAGE REGIMENS: SUSPECT PRODUCT 2. DOSE, FREQUENCY & ROUTE USED 3. THERAPY DATES (IF UNKNOWN, GIVE DURATION) 6. LOT # 7. EXP. DATE #1 NOVORAPID PENFILL 3.0 ML REGIMEN # 2 UNK (NEW CARTRIDGE), SUBCUTANEOUS.

    Description of Event or Problem · 0

    CASE DESCRIPTION: REPORTER'S CAUSALITY (NOVOPEN 4) - HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL(HYPERGLYCEMIA) : UNKNOWN. PEN DID NOT EJECT THE DOSE CORRECTLY(INCORRECT DOSE ADMINISTERED BY DEVICE) : UNKNOWN. CARTRIDGE WAS BROKEN(CRACKED PRODUCT) : UNKNOWN. COMPANY'S CAUSALITY (NOVOPEN 4) - HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL(HYPERGLYCEMIA) :POSSIBLE. PEN DID NOT EJECT THE DOSE CORRECTLY (INCORRECT DOSE ADMINISTERED BY DEVICE) : POSSIBLE. CARTRIDGE WAS BROKEN(CRACKED PRODUCT) : POSSIBLE. REPORTER'S CAUSALITY (NOVORAPID PENFILL) - HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL(HYPERGLYCEMIA) : UNKNOWN. PEN DID NOT EJECT THE DOSE CORRECTLY(INCORRECT DOSE ADMINISTERED BY DEVICE) : UNKNOWN. CARTRIDGE WAS BROKEN(CRACKED PRODUCT) : UNKNOWN. COMPANY'S CAUSALITY (NOVORAPID PENFILL) - HYPERGLYCEMIA AND BLOOD GLUCOSE LEVELS REACHED 590 MG/DL(HYPERGLYCEMIA) : POSSIBLE. PEN DID NOT EJECT THE DOSE CORRECTLY(INCORRECT DOSE ADMINISTERED BY DEVICE) : POSSIBLE. CARTRIDGE WAS BROKEN(CRACKED PRODUCT) : POSSIBLE. INVESTIGATIONAL RESULTS, NAME: NOVORAPID® PENFILL® 3 ML 100IU/ML, BATCH NUMBER: LR7BH31. DUE TO INSUFFICIENT COMPLAINT SAMPLE MATERIAL NO FURTHER INVESTIGATION WAS PERFORMED. A REFERENCE SAMPLE WAS CHEMICALLY ANALYSED AND THE RESULTS WERE WITHIN THE PRODUCT SPECIFICATIONS. IT IS NOT POSSIBLE TO TEST THE CARTRIDGE FOR INACCURACY. NONCONFORMITY-RELATED DOCUMENTATION WAS EXAMINED. NO IRREGULARITIES RECORDED AND THEREFORE NO FURTHER ACTION. THE BATCH DOCUMENTATION WAS REVIEWED. A REFERENCE SAMPLE WAS EXAMINED. AN EXAMINATION OF A REFERENCE SAMPLE SHOWED NOTHING ABNORMAL. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. BASED ON INVESTIGATIONS MADE, WE CAN CONCLUDE THAT THE INVESTIGATIONS ARE CONSIDERED SUFFICIENT. THERE IS NO ADDITIONAL INFORMATION TO BE CONSIDERED CONCERNING, BATCH RECORD AND NC/DEVIATION RELATED TO THE BATCH WERE REVIEWED. NONE ABNORMALITY OR DISCREPANCIES WERE FOUND AND THERE ISN´T A PROBABLE CAUSE FOR CRACKS IN THE FILLING AND PACKAGING PROCESS. SO, THE INTEGRITY OF THE BATCH CAN BE GUARANTEED. DURING INVESTIGATION NO IRREGULARITIES RELATED TO THE COMPLAINT WAS DETECTED ON A REFERENCE/RESERVE SAMPLE OF THE BATCH IN QUESTION. THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND FOUND TO BE NORMAL. THE RETURNED PRODUCT WAS EXAMINED VISUALLY AND THE CARTRIDGE WAS CRACKED./ IN ADDITION, LEAKAGE WAS OBSERVED. A FEW LONGITUDINAL LINES OF BREAKAGE ORIGINATING AT THE OPEN END AND PROPAGATING ALONG THE GLASS WERE OBSERVED. THE PATTERN OF THE CRACKS INDICATES THAT THE GLASS HAS BEEN SUBJECT TO A LOW ENERGY STRESS. DUE TO THE CRACKS, THE DOSAGE CAN BE INACCURATE AND CLOSURE INTEGRITY MIGHT BE COMPROMISED; THEREFORE A CRACKED PRODUCT SHOULD NOT BE USED. GLASS CONTAINERS ARE 100 % AUTOMATED INSPECTED FOR CRACKS IN THE PRODUCTION AREA AT NOVO NORDISK. FURTHER, THE BATCH DOCUMENTATION HAS BEEN REVIEWED AND RETAIN SAMPLES HAVE BEEN INSPECTED. THE BREAKAGE IS DUE TO INCORRECT HANDLING OF THE PRODUCT AFTER IT HAS LEFT NOVO NORDISK. NAME: NOVOPEN, BATCH NUMBER: UNKNOWN. NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT(S) FOR FURTHER INVESTIGATIONS. SINCE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -INVESTIGATION RESULT UPDATED, -DEVICE TAB, EU/CA TAB, DEVICE ADDENDUM TAB UPDATED. -NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: ON 23-SEP-2022: THE SUSPECTED DEVICE (NOVOPEN 4) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR THE INVESTIGATION. BATCH NUMBER OF THE DEVICE IS UNAVAILABLE, NO BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS PERFORMED. NO 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 4. HOWEVER, INVESTIGATION OF RETURNED INSULIN PRODUCT (NOVORAPID PENFILL) REVEALS CRACKS ON THE CARTRIDGE. DUE TO THE CRACKS, THE DOSAGE CAN BE INACCURATE AND CLOSURE INTEGRITY MIGHT BE COMPROMISED; THEREFORE A CRACKED PRODUCT SHOULD NOT BE USED. THE BREAKAGE IS DUE TO INCORRECT HANDLING OF THE PRODUCT AFTER IT HAS LEFT NOVO NORDISK. EVENTS ARE LISTED. THIS SINGLE CASE REPORT IS NOT CONSIDERED TO CHANGE THE CURRENT KNOWLEDGE OF THE SAFETY PROFILE OF NOVORAPID PENFILL. H3 CONTINUED: EVALUATION SUMMARY: INVESTIGATIONAL RESULTS, NAME: NOVOPEN, BATCH NUMBER: UNKNOWN. NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2822279 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Other TRESIBA FLEXTOUCH U100(INSULIN DEGLUDEC 100 IU/ML)