NOVOPEN
Report
- Report Number
- 9681821-2024-00196
- Event Type
- Injury
- Date Received
- December 19, 2024
- Report Date
- November 29, 2024
- Manufacturer
- NOVO NORDISK A/S
- Product Code
- FMF
- PMA / PMN Number
- K861686
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
CASE DESCRIPTION: SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: EXPECTED DATE OF FOLLOW UP REPORT IN EU/CA TAB WAS EXTENDED FOR NOVOPEN 6, NOVOPEN (BOTH THE PENS). NARRATIVE UPDATED ACCORDINGLY. PRELIMINARY MANUFACTURER'S COMMENT: 17-JAN-2025: THE SUSPECTED DEVICES HAVE NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO CONCLUSION REACHED.
CASE DESCRIPTION: SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: REPORTER LAST NAME CHANGED NFI UPDATED. NARRATIVE UPDATED ACCORDINGLY. REFERENCES INCLUDED: REFERENCE TYPE: E2B LINKED REPORT. REFERENCE ID#: (B)(4). REFERENCE NOTES: LINKED CASE. FINAL MANUFACTURER'S COMMENT: 02-JUN-2025: THE SUSPECTED DEVICE NOVOPEN 6 HAVE BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. UPON INVESTIGATION, DEVICE WAS FOUND TO WORK AS SPECIFIED. NO DEVICE PROBLEM FOUND. 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. SINCE NO FAULTS WERE FOUND ON THE RETURNED DEVICE NOVOPEN 6 AND ONLY VERY LIMITED INFORMATION REGARDING THE PATIENTS HANDLING OF THE SUSPECTED DEVICE IS REPORTED IN THE CASE, IT IS NOT POSSIBLE TO ELUCIDATE A CLEAR ROOT CAUSE FOR THE EXPERIENCED ADVERSE EVENT OF HYPERGLYCAEMIA. ELDERLY AGE OF THE PATIENT (73 YEARS) AND UNDERLYING DIABETES MELLITUS ARE SIGNIFICANT CONFOUNDING FACTORS FOR THE DEVELOPMENT OF HYPERGLYCAEMIA. FINAL MANUFACTURER'S COMMENT: 02-JUN-2025: THE SUSPECTED DEVICE NOVOPEN (SPECIFIC NAME OF THE DEVICE AND BATCH NUMBER UNKNOWN) HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. SINCE BATCH NUMBER OF DEVICE IS NOT AVAILABLE, NO BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS 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. ELDERLY AGE OF THE PATIENT (73 YEARS) AND UNDERLYING DIABETES MELLITUS ARE SIGNIFICANT CONFOUNDING FACTORS FOR THE DEVELOPMENT OF HYPERGLYCAEMIA.
EVENT [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) NOVOPEN IS BROKEN [DEVICE BREAKAGE]. WHEN TRYING TO INJECT, PUSH BUTTON GETS STUCK [DEVICE MECHANICAL ISSUE]. PUSH BUTTON GETS STUCK, IT DOES NOT PRESS OUT THE INSULIN AT TIMES, AND DELIVERS THE INCORRECT AMOUNT OF INSULIN, PEN STOPS DELIVERING THE MEDICATION IN THE MIDDLE OF THE INJECTION SO THEY EITHER GET TOO MUCH OR TOO LITTLE INSULIN [DEVICE DELIVERY SYSTEM ISSUE]. THE SPRING THAT CONNECTS TO THE PUSH BUTTON HAS COME OFF [DEVICE ISSUE]. VERY HIGH SUGAR LEVEL (28MMOL/L) [BLOOD GLUCOSE INCREASED]. VERY LOW SUGAR LEVELS (3-4 MMOL/L), LOW SUGAR LEVELS WOULD NORMALLY OCCUR AT NIGHT [BLOOD GLUCOSE DECREASED]. KEEP LOSING WEIGHT [WEIGHT DECREASED]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM AUSTRALIA WAS REPORTED BY A PHARMACIST AS "NOVOPEN IS BROKEN(DEVICE BREAKAGE)" WITH AN UNSPECIFIED ONSET DATE, "WHEN TRYING TO INJECT, PUSH BUTTON GETS STUCK(DEVICE MECHANICAL JAM)" WITH AN UNSPECIFIED ONSET DATE, "PUSH BUTTON GETS STUCK, IT DOES NOT PRESS OUT THE INSULIN AT TIMES, AND DELIVERS THE INCORRECT AMOUNT OF INSULIN, PEN STOPS DELIVERING THE MEDICATION IN THE MIDDLE OF THE INJECTION SO THEY EITHER GET TOO MUCH OR TOO LITTLE INSULIN(INACCURATE DELIVERY BY DEVICE)" WITH AN UNSPECIFIED ONSET DATE, "THE SPRING THAT CONNECTS TO THE PUSH BUTTON HAS COME OFF(DEVICE COMPONENT DETACHED)" WITH AN UNSPECIFIED ONSET DATE, "VERY HIGH SUGAR LEVEL (28MMOL/L)(BLOOD SUGAR INCREASED)" WITH AN UNSPECIFIED ONSET DATE, "VERY LOW SUGAR LEVELS (3-4 MMOL/L), LOW SUGAR LEVELS WOULD NORMALLY OCCUR AT NIGHT(BLOOD SUGAR DECREASED)" WITH AN UNSPECIFIED ONSET DATE, "KEEP LOSING WEIGHT(LOSING WT)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 73 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN 6 (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", NOVOPEN (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", NOVOPEN (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", RYZODEG (INSULIN ASPART, INSULIN DEGLUDEC) FROM UNKNOWN START DATE AND ONGOING FOR "DRUG USE FOR UNKNOWN INDICATION", PATIENT'S HEIGHT, WEIGHT AND BODY MASS INDEX WERE NOT REPORTED. CURRENT CONDITION: DIABETES MELLITUS (TYPE AND DURATION NOT REPORTED) HISTORICAL DRUG: INSULIN. PROCEDURE: BACK PAIN DOUBLE FUSION OPERATION (33-35 YEARS AGO), CANCER (MELANOMA) OPERATION IN THEIR ARM. (HAD AN OPERATION 26 YEARS AGO), KNEE REPLACEMENT(HOSPITALISED). ON AN UNSPECIFIED DATE, PATIENT'S DAUGHTER IN LAW REPORTED THAT PATIENT'S NOVOPEN 6 WAS BROKEN AND REPORTED THAT THIS WAS THE THIRD ONE THAT HAD HAPPENED (THEY HAVE HAD TWO OTHER PENS THAT WERE FAULTY). PATIENT'S DAUGHTER IN LAW REPORTED THAT THE ISSUE THEY EXPERIENCING WAS THAT WHEN THEY PUT THE NEEDLE ON, IT DOES NOT ATTACH PROPERLY, AND WHEN TRYING TO INJECT, THE BUTTON GETS STUCK AND MENTIONED THAT THE SPRING THAT CONNECTS TO THE PUSH BUTTON HAS COME OFF.BECAUSE THE PUSH BUTTON GOT STUCK, IT DOES NOT PRESS OUT THE INSULIN AT TIMES, AND DELIVERS THE INCORRECT AMOUNT OF INSULIN. PATIENT'S DAUGHTER IN LAW STATED THAT THE PEN STOPS DELIVERING THE MEDICATION IN THE MIDDLE OF THE INJECTION SO PATIENT EITHER GET TOO MUCH OR TOO LITTLE INSULIN. THIS CAUSED THE PATIENT TO HAVE VERY HIGH(BLOOD SUGAR INCREASED) (28 MMOL/L) AND VERY LOW SUGAR LEVELS ( 3-4 MMOL/L)(BLOOD SUGAR DECREASED). THE LOW SUGAR LEVELS WOULD NORMALLY OCCUR AT NIGHT. PATIENT'S DAUGHTER IN LAW REPORTED THAT PATIENT DID NOT RECEIVE ANY INSULIN THE NIGHT BEFORE YESTERDAY AND YESTERDAY DUE TO THE FAULTY NOVOPEN. PATIENT'S DAUGHTER IN LAW SAID THAT PATIENT CURRENTLY USING RYZODEG TWICE A DAY AND ALSO MENTIONED PATIENT KEEP LOSING WEIGHT(WEIGHT) AND THAT PATIENT'S SUGAR WAS NOT WELL CONTROLLED SINCE USING NOVOPEN. IT WAS REPORTED THE SPECIFIC EVENTS VERY HIGH (28MMOL/L) AND VERY LOW SUGAR LEVELS (3-4 MMOL/L)' WAS WITH THE REPORTED NOVOPEN 6, BATCH NO. NVGAT23. HOWEVER 'KEEP LOSING WEIGHT', 'SUGAR IS NOT WELL CONTROLLED SINCE USING NOVOPEN', 'FAULTY NOVOPEN', 'PUSH BUTTON GETS STUCK', 'PEN STOPS DELIVERING THE MEDICATION IN THE MIDDLE OF THE INJECTION' AND 'THEY EITHER GET TOO MUCH OR TOO LITTLE INSULIN' WAS EXPERIENCED WITH ALL 3 NOVOPENS (INCLUDING THE 'TWO OTHER PENS THAT WERE FAULTY'). THE REPORTER WAS UNABLE TO CLARIFY IF ALL THREE DEVICES WERE NOVOPEN 6, AS THE PATIENT DID NOT HAVE THE OTHER TWO PENS, THEY WERE NOT ABLE TO TELL THE SPECIFIC NOVOPEN. BATCH NUMBERS: NOVOPEN 6: NVGAT23 NOVOPEN : REQUESTED. NOVOPEN : REQUESTED. RYZODEG: REQUESTED. ACTION TAKEN TO NOVOPEN 6 WAS NOT REPORTED. ACTION TAKEN TO NOVOPEN WAS NOT REPORTED. ACTION TAKEN TO NOVOPEN WAS NOT REPORTED. ACTION TAKEN TO RYZODEG WAS NOT REPORTED. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED FOR RYZODEG DOESN'T APPLY EVENT REAPPEARED AFTER REINTRODUCTION OF RYZODEG DOESN'T APPLY. THE OUTCOME FOR THE EVENT "NOVOPEN IS BROKEN (DEVICE BREAKAGE)" WAS UNKNOWN. THE OUTCOME FOR THE EVENT "WHEN TRYING TO INJECT, PUSH BUTTON GETS STUCK (DEVICE MECHANICAL JAM)" WAS UNKNOWN. THE OUTCOME FOR THE EVENT "PUSH BUTTON GETS STUCK, IT DOES NOT PRESS OUT THE INSULIN AT TIMES, AND DELIVERS THE INCORRECT AMOUNT OF INSULIN, PEN STOPS DELIVERING THE MEDICATION IN THE MIDDLE OF THE INJECTION SO THEY EITHER GET TOO MUCH OR TOO LITTLE INSULIN (INACCURATE DELIVERY BY DEVICE)" WAS UNKNOWN. THE OUTCOME FOR THE EVENT "THE SPRING THAT CONNECTS TO THE PUSH BUTTON HAS COME OFF(DEVICE COMPONENT DETACHED)" WAS UNKNOWN. THE OUTCOME FOR THE EVENT "VERY HIGH SUGAR LEVEL (28MMOL/L)(BLOOD SUGAR INCREASED)" WAS UNKNOWN. THE OUTCOME FOR THE EVENT "VERY LOW SUGAR LEVELS (3-4 MMOL/L), LOW SUGAR LEVELS WOULD NORMALLY OCCUR AT NIGHT(BLOOD SUGAR DECREASED)" WAS UNKNOWN. THE OUTCOME FOR THE EVENT "KEEP LOSING WEIGHT(LOSING WT)" WAS UNKNOWN. EVENT ONSET DATE IS NOT REPORTED IN THE CASE. HOWEVER, THE INCIDENT DATES ARE CAPTURED TO ENSURE THE MIR FORM IS GENERATED. REFERENCES INCLUDED: REFERENCE TYPE: E2B LINKED REPORT, REFERENCE ID#: (B)(4), REFERENCE NOTES: LINKED CASE. THIS REPORT IS FOR A FOREIGN DEVICE THAT IS ASSESSED AS "SIMILAR" TO US MARKETED NOVOPEN ECHO. PRELIMINARY MANUFACTURER'S COMMENT: 16-DEC-2024: THE SUSPECTED DEVICES HAVE NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO CONCLUSION REACHED.
CASE DESCRIPTION: INVESTIGATION RESULTS: NAME: NOVOPEN 6, BATCH NUMBER: NVGAT23. A VISUAL EXAMINATION OF THE RETURNED PRODUCT WAS PERFORMED. THE NUMBER OF COMPLAINTS ON THE BATCH WAS EVALUATED AND, WHEN APPLICABLE, RELEVANT ACTIONS WERE TAKEN. THE DEVICE WAS INVESTIGATED FOLLOWING THE COMPLAINT OF DELIVERY ISSUES/MALFUNCTION AND INNACURATE DOSAGE. THE ELECTRONIC REGISTER WAS CHECKED. A FEW NUMBER OF TIME-OUT DOSES OBSERVED IN THE ELECTRONIC LOGS. NO OTHER ERROS OBSERVED. VISUAL EXAMINATION AND FUNCTIONAL TESTING WERE PERFORMED. WHEN THE DOSE BUTTON WAS FULLY DEPRESSED, THE ELECTRONIC DISPLAY SHOWED THE LAST DOSE DISPENSED. NO CARTRIDGE HOLDER RECEIVED WITH THE PEN. THE DEVICE WAS TESTED WITH A RANDOM CARTRIDGE AND A RANDOM CARTRIDGE HOLDER. A NOVO NORDISK NEEDLE WAS MOUNTED. DURING TESTING IT WAS POSSIBLE TO DELIVER PREPARATION FROM THE CARTRIDGE AND THE MEMORY DISPLAY REFLECTED THE SET DOSES. NO IRREGULARITIES RELATED TO DIFFICULTIES IN DISPENSING THE DRUG WERE FOUND DURING FUNCTIONAL TEST. THE PISTON ROD WAS FOUND TO BE NORMAL IN APPEARANCE AND FUNCTION. DURING THE FUNCTIONAL TEST, THE MECHANICAL AND ELECTRONIC FUNCTIONS WERE FOUND TO OPERATE NORMALLY. THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM CARTRIDGE AND A RANDOM CARTRIDGE HOLDER. THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. THE ELECTRONIC DISPLAY SHOWED "ERROR" AFTER THE DOSE BUTTON WAS FULLY DEPRESSED. THIS IS A NORMAL FUNCTION OF THE PEN TO WARN THE USER OF NON-RECOMMENDED USER BEHAVIOUR. THE USER SPLIT THE SELECTED DOSE INTO TWO OR MORE SMALLER DOSES WHICH WERE DELIVERED OVER A PERIOD OF MORE THAN 15 MINUTES. NAME: NOVOPEN #1, BATCH NUMBER: UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. NAME: NOVOPEN #2, BATCH NUMBER: UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. NAME: RYZODEG, 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: INVESTIGATION RESULTS UPDATED FOR NOVOPEN 6, NOVOPEN #1, NOVOPEN #2 AND RYZODEG DEVICE TAB OF NOVOPEN 6: IS NON-REPORTABLE FIELD UPDATED TO NO, MALFUNCTION FIELD UPDATED TO YES, IMPROPER USE OR STORAGE UPDATED TO YES, DEVICE AVAILABLE FOR EVALUATION AND RETURNED TO MANUFACTURER ON UPDATED -EU/CA TAB OF NOVOPEN 6: FINAL REPORT CHECK BOX TICKED, EXPECTED DATE OF FOLLOW UP REPORT REMOVED, CURRENT LOCATION OF DEVICE UPDATED, FURTHER INVESTIGATION UPDATED DEVICE TAB OF NOVOPEN #1 AND NOVOPEN #2: IS NON-REPORTABLE FIELD UPDATED TO NO, MALFUNCTION FIELD UPDATED TO NO EU/CA TAB OF NOVOPEN #1 AND NOVOPEN #2: FINAL REPORT CHECK BOX TICKED, EXPECTED DATE OF FOLLOW UP REPORT REMOVED DEVICE ADDENDUM OF NOVOPEN 6, NOVOPEN #1 AND NOVOPEN #2: IMDRF CODES UPDATED NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: (B)(6)2025: THE SUSPECTED DEVICE NOVOPEN 6 HAVE BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. UPON INVESTIGATION, DEVICE WAS FOUND TO WORK AS SPECIFIED. NO DEVICE PROBLEM FOUND. 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. SINCE NO FAULTS WERE FOUND ON THE RETURNED DEVICE NOVOPEN 6 AND ONLY VERY LIMITED INFORMATION REGARDING THE PATIENTS HANDLING OF THE SUSPECTED DEVICE IS REPORTED IN THE CASE, IT IS NOT POSSIBLE TO ELUCIDATE A CLEAR ROOT CAUSE FOR THE EXPERIENCED ADVERSE EVENT OF HYPERGLYCAEMIA. ELDERLY AGE OF THE PATIENT (73 YEARS) AND UNDERLYING DIABETES MELLITUS ARE SIGNIFICANT CONFOUNDING FACTORS FOR THE DEVELOPMENT OF HYPERGLYCAEMIA. FINAL MANUFACTURER'S COMMENT: (B)(6)2025: THE SUSPECTED DEVICE NOVOPEN (SPECIFIC NAME OF THE DEVICE AND BATCH NUMBER UNKNOWN) HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. SINCE BATCH NUMBER OF DEVICE IS NOT AVAILABLE, NO BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS 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. ELDERLY AGE OF THE PATIENT (73 YEARS) AND UNDERLYING DIABETES MELLITUS ARE SIGNIFICANT CONFOUNDING FACTORS FOR THE DEVELOPMENT OF HYPERGLYCAEMIA. H3 CONTINUED: EVALUATION SUMMARY. NAME: NOVOPEN #1, 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 |
|---|---|---|---|---|---|---|---|
| 2088200 | NOVOPEN | INSULIN DELIVERY DEVICE | FMF | NOVO NORDISK A/S | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Other |