HUMAPEN LUXURA HALF-DOSE PEN
Report
- Report Number
- 1819470-2023-00080
- Event Type
- Injury
- Date Received
- December 1, 2023
- Date of Event
- January 31, 2022
- Report Date
- January 4, 2024
- Manufacturer
- ELI LILLY AND COMPANY
- Product Code
- FMF
- UDI-DI
- 00300029673019
- PMA / PMN Number
- K100988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- 003
Narratives
SINCE THE DEVICE IS NOT BEING RETURNED, EVALUATION FOR A MALFUNCTION IS NOT POSSIBLE. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.
B.5. NARRATIVE FIELD: NEW, UPDATED, AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS IN B.5. PLEASE REFER TO UPDATE STATEMENT(S) DATED 20DEC2023 IN THE B.5. FIELD. NO FURTHER FOLLOW-UP IS PLANNED. EVALUATION SUMMARY A CONSUMER REPORTED ON BEHALF OF A PEDIATRIC MALE PATIENT THAT THE INJECTION SCREW OF THE PATIENT'S HUMAPEN LUXURA HD WAS STUCK AND NO INSULIN WAS RELEASED. THE PATIENT EXPERIENCED INCREASED BLOOD GLUCOSE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. ALL HUMAPEN LUXURA HD DEVICES ARE ASSESSED FOR INJECTION SCREW TRAVEL AT THE END OF THE MANUFACTURING PROCESS, THUS ENSURING DEVICE FUNCTIONALITY WITH HIGH PROBABILITY. THE REPORTER STATED THE PEN WAS STORED IN THE REFRIGERATOR WITH THE NEEDLE ATTACHED IN THE SUMMER AND THE PEN NEEDLE IS CHANGED EVERY THREE DAYS. THE CORE INSTRUCTIONS FOR USE STATE TO USE A NEW NEEDLE FOR EACH INJECTION, TO REMOVE THE NEEDLE AFTER EVERY USE, TO NOT STORE THE PEN WITH THE NEEDLE ATTACHED, AND TO NOT TO STORE THE DEVICE IN A REFRIGERATOR. IN ADDITION, THE DEVICE WAS USED SINCE 2018 (5 YEARS). THE CORE INSTRUCTIONS FOR USE STATE THE HUMAPEN LUXURA HD IS DESIGNED TO BE USED FOR UP TO 3 YEARS AFTER FIRST USE. THERE IS EVIDENCE OF IMPROPER USE AND STORAGE. THE USER REUSES NEEDLES AND STORES THE DEVICE IN THE REFRIGERATOR WITH THE NEEDLE ATTACHED. THESE MISUSES MAY BE RELEVANT TO THE COMPLAINT AND THE EVENT OF INCREASED BLOOD GLUCOSE. THE DEVICE WAS USED BEYOND ITS APPROVED USE LIFE. IT IS UNKNOWN IF THIS IS RELEVANT TO THE EVENT OF INCREASED BLOOD GLUCOSE.
LILLY CASE ID: EG202311011909. THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT:(B)(4). THIS SPONTANEOUS CASE REPORTED BY CONSUMERS WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND A PRODUCT COMPLAINT (PC), CONCERNED A 07-YEAR-OLD PAEDIATRIC (AT THE TIME OF INITIAL REPORT) MALE PATIENT OF AN UNKNOWN ORIGIN. MEDICAL HISTORIES INCLUDED ELEVATED BLOOD GLUCOSE LEVEL DUE TO WHICH HE WAS HOSPITALIZED AND DIAGNOSED WITH DIABETES TYPE I IN 2019. CONCOMITANT MEDICATION INCLUDED INSULIN DEGLUDEC USED FOR THE TREATMENT OF DIABETES. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG, 100 U/ML), FROM A CARTRIDGE VIA HUMAPEN LUXURA HALF DOSE (HD) PEN, AT 2 INTERNATIONAL UNITS (IU) IN MORNING, 2 IU AT NOON AND 1 IU IN EVENING, ADMINISTERED SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES TYPE I BEGINNING ON AN UNKNOWN DATE IN 2019. APPROXIMATELY FROM ON AN UNKNOWN DATE IN 2018, HE STARTED USING HUMAPEN LUXURA HD PEN. ON AN UNKNOWN DATE IN 2022, WHILE ON INSULIN LISPRO THERAPY, HE EXPERIENCED HIS BLOOD GLUCOSE LEVEL WAS ELEVATED (EXACT VALUES, UNITS AND REFERENCE RANGES WERE UNKNOWN) DUE TO WHICH HE WAS HOSPITALIZED FOR 10 DAYS. THE DATE OF ADMISSION AND DISCHARGE WAS UNKNOWN. DUE TO ELEVATED BLOOD GLUCOSE LEVEL, THE PHYSICIAN RECOMMENDED TO CHANGE THE DAILY DOSE OF INSULIN LISPRO TO AN UNKNOWN DOSE, AND ALSO PRESCRIBED INSULIN DEGLUDEC. ON AN UNKNOWN DATE IN JUL-2023, THE HUMAPEN LUXURA HD PEN WAS STUCK, AND NO INSULIN WAS RELEASED (PC/LOT NUMBER: 6833258/UNKNOWN). THE DEVICE WAS STORED IN THE REFRIGERATOR ATTACHED TO THE NEEDLE IN SUMMER AND STORED IT IN ROOM TEMPERATURE IN WINTER (IMPROPER USE OR STORAGE). THE NEEDLE OF THE PEN WAS CHANGED IN EVERY THREE TIMES OF USING. ON AN UNKNOWN DATE IN NOV-23, HE SUFFERED FROM DISTURBANCE IN HIS BLOOD GLUCOSE LEVEL, SOMETIMES ELEVATED AND SOMETIMES ELSE DECREASED AS HIS RANDOM BLOOD GLUCOSE WAS UNSTABLE (40MG/DL-300MG/DL) AND HBA1C WAS 9.5MMOL/MOL. FROM ON AN UNKNOWN DATE, HIS VITAMIN D WAS DECREASED (EXACT VALUES, UNITS AND REFERENCE RANGES WERE UNKNOWN) DUE TO WHICH HE RECEIVED V-DROP (AS REPORTED) AS VITAMIN D SUPPLEMENT. FURTHER INFORMATION REGARDING THE CORRECTIVE TREATMENT FOR REMAINING EVENTS WAS UNKNOWN. HE HAD RECOVERED FROM THE EVENT OF BLOOD GLUCOSE INCREASED AND HAD NOT RECOVERED FROM THE EVENTS OF BLOOD GLUCOSE FLUCTUATION AND VITAMIN D DECREASED. INSULIN LISPRO TREATMENT WAS CONTINUED. THE USER OF THE HUMAPEN LUXURA HD PEN WAS THE FATHER OR MOTHER OF THE PATIENT AND HIS/HER TRAINING STATUS WAS NOT PROVIDED. THE HUMAPEN LUXURA HD PEN GENERAL MODEL DURATION OF USE AND THE SUSPECT OF USE WERE NOT REPORTED HOWEVER, IT WAS STARTED ON AN UNKNOWN DATE IN 2018. THE ACTION TAKEN WITH THE SUSPECT HUMAPEN LUXURA HD PEN WAS UNKNOWN AND ITS RETURN WAS NOT EXPECTED. THE INITIAL REPORTING CONSUMER DID NOT KNOW IF THE EVENTS WERE RELATED WITH INSULIN LISPRO TREATMENT. THE REPORTING CONSUMER DID NOT RELATE THE EVENTS WITH HUMAPEN LUXURA HALF DOSE PEN. EDIT (B)(6) 2023: UPON REVIEW OF THE INFORMATION RECEIVED ON (B)(6) 2023, REMOVED THE OUTCOME DETAILS AND RELATEDNESS INFORMATION REGARDING THE DELETED EVENT OF GLYCOSYLATED HAEMOGLOBIN DECREASED. EDIT (B)(6) 2023: UPDATED MEDWATCH AND EUROPEAN AND CANADIAN (EU/CA) FIELDS FOR EXPEDITED DEVICE REPORTING. NO NEW INFORMATION ADDED.
LILLY CASE ID: (B)(6). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: 6833258. THIS SPONTANEOUS CASE REPORTED BY CONSUMERS WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS AND A PRODUCT COMPLAINT (PC), CONCERNED A 07-YEAR-OLD PAEDIATRIC (AT THE TIME OF INITIAL REPORT) MALE PATIENT OF AN UNKNOWN ORIGIN. MEDICAL HISTORIES INCLUDED ELEVATED BLOOD GLUCOSE LEVEL DUE TO WHICH HE WAS HOSPITALIZED AND DIAGNOSED WITH DIABETES TYPE I IN 2019. CONCOMITANT MEDICATION INCLUDED INSULIN DEGLUDEC USED FOR THE TREATMENT OF DIABETES. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG, 100 U/ML), FROM A CARTRIDGE VIA HUMAPEN LUXURA HALF DOSE (HD) PEN, AT 2 INTERNATIONAL UNITS (IU) IN MORNING, 2 IU AT NOON AND 1 IU IN EVENING, ADMINISTERED SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES TYPE I BEGINNING ON AN UNKNOWN DATE IN 2019. APPROXIMATELY FROM ON AN UNKNOWN DATE IN 2018, HE STARTED USING HUMAPEN LUXURA HD PEN. ON AN UNKNOWN DATE IN 2022, WHILE ON INSULIN LISPRO THERAPY, HE EXPERIENCED HIS BLOOD GLUCOSE LEVEL WAS ELEVATED (EXACT VALUES, UNITS AND REFERENCE RANGES WERE UNKNOWN) DUE TO WHICH HE WAS HOSPITALIZED FOR 10 DAYS. THE DATE OF ADMISSION AND DISCHARGE WAS UNKNOWN. DUE TO ELEVATED BLOOD GLUCOSE LEVEL, THE PHYSICIAN RECOMMENDED TO CHANGE THE DAILY DOSE OF INSULIN LISPRO TO AN UNKNOWN DOSE, AND ALSO PRESCRIBED INSULIN DEGLUDEC. ON AN UNKNOWN DATE IN (B)(6) 2023, THE HUMAPEN LUXURA HD PEN WAS STUCK, AND NO INSULIN WAS RELEASED (PC/LOT NUMBER: 6833258/UNKNOWN). THE DEVICE WAS STORED IN THE REFRIGERATOR ATTACHED TO THE NEEDLE IN SUMMER AND STORED IT IN ROOM TEMPERATURE IN WINTER (CONSIDERED IMPROPER USE OR STORAGE). THE NEEDLE OF THE PEN WAS CHANGED IN EVERY THREE TIMES OF USING. ON AN UNKNOWN DATE IN (B)(6) 2023, HE SUFFERED FROM DISTURBANCE IN HIS BLOOD GLUCOSE LEVEL, SOMETIMES ELEVATED AND SOMETIMES ELSE DECREASED AS HIS RANDOM BLOOD GLUCOSE WAS UNSTABLE (40MG/DL-300MG/DL) AND HBA1C WAS 9.5MMOL/MOL. FROM ON AN UNKNOWN DATE, HIS VITAMIN D WAS DECREASED (EXACT VALUES, UNITS AND REFERENCE RANGES WERE UNKNOWN) DUE TO WHICH HE RECEIVED V-DROP (AS REPORTED) AS VITAMIN D SUPPLEMENT. FURTHER INFORMATION REGARDING THE CORRECTIVE TREATMENT FOR REMAINING EVENTS WAS UNKNOWN. HE HAD RECOVERED FROM THE EVENT OF BLOOD GLUCOSE INCREASED AND HAD NOT RECOVERED FROM THE EVENTS OF BLOOD GLUCOSE FLUCTUATION AND VITAMIN D DECREASED. INSULIN LISPRO TREATMENT WAS CONTINUED. THE USER OF THE HUMAPEN LUXURA HD PEN WAS THE FATHER OR MOTHER OF THE PATIENT AND HIS/HER TRAINING STATUS WAS NOT PROVIDED. THE HUMAPEN LUXURA HD PEN GENERAL MODEL DURATION OF USE AND THE SUSPECT OF USE WERE STARTED ON AN UNKNOWN DATE IN 2018. THE SUSPECT HUMAPEN LUXURA HD PEN WAS NOT RETURNED TO THE MANUFACTURER. THE INITIAL REPORTING CONSUMER DID NOT KNOW IF THE EVENTS WERE RELATED WITH INSULIN LISPRO TREATMENT. THE REPORTING CONSUMER DID NOT RELATE THE EVENTS WITH HUMAPEN LUXURA HALF DOSE PEN. EDIT 23-NOV-2023: UPON REVIEW OF THE INFORMATION RECEIVED ON 18-NOV-2023, REMOVED THE OUTCOME DETAILS AND RELATEDNESS INFORMATION REGARDING THE DELETED EVENT OF GLYCOSYLATED HAEMOGLOBIN DECREASED. EDIT 01DEC2023: UPDATED MEDWATCH AND EUROPEAN AND CANADIAN (EU/CA) FIELDS FOR EXPEDITED DEVICE REPORTING. NO NEW INFORMATION ADDED. UPDATE 20DEC2023: ADDITIONAL INFORMATION RECEIVED ON 14DEC2023 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE. ENTERED THE DEVICE SPECIFIC SAFETY SUMMARY (DSSS), THE MEDWATCH, EU/CA FOR THE SUSPECT HUMAPEN LUXURA HALF-DOSE PEN DEVICE ASSOCIATED WITH (B)(4) . CORRESPONDING FIELDS AND NARRATIVE UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1605090 | HUMAPEN LUXURA HALF-DOSE PEN | FOR TREATMENT PURPOSES | FMF | ELI LILLY AND COMPANY | MS9673A | 00300029673019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Male | Hospitalization |