BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 14362317 · Received May 11, 2022

    Report

    Report Number
    9681821-2022-00036
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    March 6, 2022
    Report Date
    March 11, 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
    GR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) PEN GOT BLOCKED [DEVICE OCCLUSION]. HYPERGLYCAEMIA (GLUCOSE LEVELS WERE 560 ) [HYPERGLYCAEMIA]. PATIENT'S GLUCOSE LEVELS ARE NOT REGULATED (AT NIGHT HER GLUCOSE LEVELS WERE 400 AND IN THE MORNING WERE 40-70) [BLOOD GLUCOSE FLUCTUATION] LACK OF EFFICACY [DRUG INEFFECTIVE]. CASE DESCRIPTION: STUDY ID: 831713-NOVOCARE FOR DIABETES. STUDY DESCRIPTION: 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. PATIENT'S HEIGHT: (B)(6). PATIENT'S WEIGHT: (B)(6). PATIENT'S BMI: (B)(6). THIS SERIOUS SOLICITED REPORT FROM GREECE WAS REPORTED BY A NURSE AS "PEN GOT BLOCKED(DEVICE BLOCKAGE)" WITH AN UNSPECIFIED ONSET DATE , "HYPERGLYCAEMIA (GLUCOSE LEVELS WERE 560 )(HYPERGLYCAEMIA)" BEGINNING ON (B)(6) 2022 , "PATIENT'S GLUCOSE LEVELS ARE NOT REGULATED (AT NIGHT HER GLUCOSE LEVELS WERE 400 AND IN THE MORNING WERE 40-70)(BLOOD GLUCOSE FLUCTUATION)" WITH AN UNSPECIFIED ONSET DATE , "LACK OF EFFICACY(LACK OF DRUG EFFECT)" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A (B)(6) OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN 4 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", PROTAPHANE PENFILL (INSULIN HUMAN) SUSPENSION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - UNK, SUBCUTANEOUS) FROM UNKNOWN START DATE TO (B)(6) 2022 FOR "TYPE 2 DIABETES MELLITUS". DOSAGE REGIMENS: NOVOPEN 4: PROTAPHANE PENFILL: NOT REPORTED TO NOT REPORTED, NOT REPORTED TO (B)(6) 2022; CURRENT CONDITION: TYPE 2 DIABETES MELLEITUS, HIGH BLOOD PRESSURE. CONCOMITANT MEDICATIONS INCLUDED - FORXIGA(DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE), JANUMET(METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE), KARVEZIDE(HYDROCHLOROTHIAZIDE, IRBESARTAN) ONGOING. ON 05-MAR-2022 AND TO INITIATE ANOTHER THERAPY WITH FORXIGA AND JANUMET. ON AN UNSPECIFIED DATE, THE PATIENT'S NOVOPEN 4 WAS BLOCKED. ON (B)(6) 2022, PATIENT BLOOD GLUCOSE LEVELS WERE 560 AND WAS ADMINISTERED TO THE HOSPITAL UNTIL (B)(6) 2022. IT WAS RECOMMENDED BY HER HCP TO CONTINUE WITH PROTAPHANE AND TO TAKE 28IU IN THE MORNING AND 16IU AT NIGHT. HER GLUCOSE LEVELS ARE NOT YET REGULATED AND SHE IS MONITORED BY HER HCP. ON AN UNSPECIFIED DATE, PATIENT'S BLOOD GLUCOSE LEVELS ARE NOT REGULATED AS EXPECTED FOR THE LAST MONTH SINCE AT NIGHT HER GLUCOSE LEVELS WERE 400 AND IN THE MORNING WERE 40-70. AS A CORRECTIVE ACTION IT WAS DECIDED BY HER HCP TO INTERRUPT THERAPY WITH PROTAPHANE. THERE WAS NO CHANGE IN DIET OR PHYSICAL ACTIVITY. THE SUSPECTED PRODUCT HAS NOT BEEN INJECTED INTO A SKIN AREA WITH LUMPS. BATCH NUMBERS: NOVOPEN 4: NOT REPORTED PROTAPHANE PENFILL: LR7AB87, LR7AB87; ACTION TAKEN TO NOVOPEN 4 WAS NOT REPORTED ACTION TAKEN TO PROTAPHANE PENFILL WAS REPORTED AS PRODUCT DISCONTINUED. THE OUTCOME FOR THE EVENT "PEN GOT BLOCKED(DEVICE BLOCKAGE)" WAS NOT REPORTED. ON (B)(6) 2022 THE OUTCOME FOR THE EVENT "HYPERGLYCAEMIA (GLUCOSE LEVELS WERE 560 )(HYPERGLYCAEMIA)" WAS RECOVERED. THE OUTCOME FOR THE EVENT "PATIENT'S GLUCOSE LEVELS ARE NOT REGULATED (AT NIGHT HER GLUCOSE LEVELS WERE 400 AND IN THE MORNING WERE 40-70)(BLOOD GLUCOSE FLUCTUATION)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "LACK OF EFFICACY(LACK OF DRUG EFFECT)" WAS UNKNOWN. REPORTER'S CAUSALITY (NOVOPEN 4) - PEN GOT BLOCKED(DEVICE BLOCKAGE) : UNKNOWN, HYPERGLYCAEMIA (GLUCOSE LEVELS WERE 560 )(HYPERGLYCAEMIA) : UNKNOWN, PATIENT'S GLUCOSE LEVELS ARE NOT REGULATED (AT NIGHT HER GLUCOSE LEVELS WERE 400 AND IN THE MORNING WERE 40-70)(BLOOD GLUCOSE FLUCTUATION) : UNKNOWN, LACK OF EFFICACY(LACK OF DRUG EFFECT) : UNKNOWN. COMPANY'S CAUSALITY (NOVOPEN 4) - PEN GOT BLOCKED(DEVICE BLOCKAGE) : POSSIBLE, HYPERGLYCAEMIA (GLUCOSE LEVELS WERE 560 )(HYPERGLYCAEMIA) : UNLIKELY, PATIENT'S GLUCOSE LEVELS ARE NOT REGULATED (AT NIGHT HER GLUCOSE LEVELS WERE 400 AND IN THE MORNING WERE 40-70)(BLOOD GLUCOSE FLUCTUATION) : POSSIBLE. LACK OF EFFICACY(LACK OF DRUG EFFECT) : POSSIBLE. REPORTER'S CAUSALITY (PROTAPHANE PENFILL) - PEN GOT BLOCKED(DEVICE BLOCKAGE) : UNKNOWN, HYPERGLYCAEMIA (GLUCOSE LEVELS WERE 560 )(HYPERGLYCAEMIA) : PROBABLE, PATIENT'S GLUCOSE LEVELS ARE NOT REGULATED (AT NIGHT HER GLUCOSE LEVELS WERE 400 AND IN THE MORNING WERE 40-70)(BLOOD GLUCOSE FLUCTUATION) : PROBABLE, LACK OF EFFICACY(LACK OF DRUG EFFECT) : UNKNOWN. COMPANY'S CAUSALITY (PROTAPHANE PENFILL) - PEN GOT BLOCKED(DEVICE BLOCKAGE) : POSSIBLE, HYPERGLYCAEMIA (GLUCOSE LEVELS WERE 560 )(HYPERGLYCAEMIA) : POSSIBLE, PATIENT'S GLUCOSE LEVELS ARE NOT REGULATED (AT NIGHT HER GLUCOSE LEVELS WERE 400 AND IN THE MORNING WERE 40-70)(BLOOD GLUCOSE FLUCTUATION) : POSSIBLE, LACK OF EFFICACY(LACK OF DRUG EFFECT) : POSSIBLE. SINCE THE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: STOP DATE AND ACTION TAKEN OF THE SUSPECT PROTAPHANE UPDATED, SUSPECT NOVOPEN 4 ADDED, EVENT OF DEVICE BLOCKAGE ADDED, CAUSALITY UPDATED, NARRATIVE EDITTED ACCORDINGLY. REFERENCES INCLUDED: REFERENCE ID#: 245915, REFERENCE NOTES: ADDITIONAL REFERENCE NO., REFERENCE TYPE: E2B COMPANY NUMBER, REFERENCE ID#: GR-NOVOPROD-900415. REPORTER COMMENT: ON AN UNKNOWN DATE, PATIENT HAD A PROBLEM WITH THE PEN. THE MEDICINE DID NOT COME OUT, BUT THE NEXT DAY IT WAS WORKING PROPERLY AGAIN: UNKNOWN WHICH PEN. ADDITIONAL DOSAGE REGIMENS: SUSPECT PRODUCT 2. DOSE, FREQUENCY & ROUTE USED 3. THERAPY DATES (IF UNKNOWN, GIVE DURATION) 6. LOT # 7. EXP. DATE #1 INSULATARD PENFILL HM(GE) 3.0 ML REGIMEN # 2 44 IU, QD(28IU IN THE MORNING AND 16IU AT NIGHT), SUBCUTANEOUS UNK TO 03/05/2022 LR7AB87 12/--/2023.

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATION RESULTS : PRODUCT NAME: NOVOPEN 4, BATCH NUMBER: UNKNOWN. NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. PRODUCT NAME: INSULATARD PENFILL, BATCH NUMBER: UNKNOWN. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. SINCE THE LAST SUBMISSION, THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: INVESTIGATION RESULTS UPDATED, B,C,D AND G CODES UPDATED, NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: 10-OCT-2022: THE SUSPECTED DEVICE NOVOPEN 4 HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. BATCH NUMBER OF DEVICES IS NOT AVAILABLE DESPITE REPEATED EFFORTS FIND THE SAME. BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS WAS NOT PERFORMED. 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. ELDERLY AGE OF THE PATIENT AND UNDERLYING TYPE 2 DIABETES MELLITUS ARE SIGNIFICANT CONFOUNDING FACTORS FOR THE DEVELOPMENT OF BLOOD GLUCOSE FLUCTUATION AND HYPERGLYCAEMIA. EVENTS ARE LISTED. THIS SINGLE CASE REPORT IS NOT CONSIDERED TO CHANGE THE CURRENT KNOWLEDGE OF THE SAFETY PROFILE OF INSULATARD PENFILL. H3 CONTINUED: EVALUATION SUMMARY. PRODUCT NAME: NOVOPEN 4, 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
    872087 NOVOPEN 4 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Other| H FORXIGA.| JANUMET.| KARVEZIDE.