NOVOFINE
Report
- Report Number
- 9681821-2022-00082
- Event Type
- Injury
- Date Received
- October 31, 2022
- Report Date
- October 4, 2022
- Manufacturer
- NOVO NORDISK A/S
- Product Code
- FMI
- PMA / PMN Number
- K861686
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- 003
Narratives
EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). HYPERGLYCEMIA [HYPERGLYCAEMIA]. PEN CANNOT DELIVER: GAP BETWEEN RUBBER PLATE AND PISTON ROD [DEVICE FAILURE]. GIT DISTURBANCE [GASTROINTESTINAL DISORDER]. VOMITING [VOMITING]. HYPOTENSION [HYPOTENSION]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM EGYPT WAS REPORTED BY A CONSUMER AS "HYPERGLYCEMIA(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE, "PEN CANNOT DELIVER: GAP BETWEEN RUBBER PLATE AND PISTON ROD(DEVICE FAILURE)" WITH AN UNSPECIFIED ONSET DATE, "GIT DISTURBANCE(GASTROINTESTINAL DISORDER)" WITH AN UNSPECIFIED ONSET DATE, "VOMITING(VOMITING)" WITH AN UNSPECIFIED ONSET DATE, "HYPOTENSION(HYPOTENSION)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 16 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH TRESIBA FLEXTOUCH U100 (INSULIN DEGLUDEC 100 IU/ML) FROM UNKNOWN START DATE AND ONGOING FOR "TYPE 1 DIABETES MELLITUS", NOVOFINE,UNSPECIFIED (NEEDLE) FROM UNKNOWN START DATE FOR "TYPE 1 DIABETES MELLITUS", NOVORAPID PENFILL (INSULIN ASPART) SOLUTION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - 70 IU, QD, SUBCUTANEOUS) (THERAPY DATES - ONGOING) FROM UNKNOWN START DATE AND ONGOING FOR "TYPE 1 DIABETES MELLITUS." PATIENT'S HEIGHT: 150 CM. PATIENT'S WEIGHT: 51-52 KG. PATIENT'S BMI (BODY MASS INDEX) NOT REPORTED. CURRENT CONDITION: TYPE 1 DIABETES MELLITUS. (SINCE 2011 OR 2012). CONCOMITANT PRODUCTS INCLUDED - NOVOPEN 4(INSULIN DELIVERY DEVICE) N/A. TREATMENT INCLUDED - DANSET(ONDANSETRON HYDROCHLORIDE). IT WAS REPORTED THAT THE PATIENT STARTED USING NOVORAPID PENFILS AND TRESIBA SINCE (B)(6) 2022. ON AN UNSPECIFIED DATE, THE PATIENT SUFFERED HYPERGLYCEMIA SINCE 4 DAYS (FBG WAS 380-440 MG/DL 4 DAYS AGO), AND 164 MG/DL (FBG). ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED. THE PATIENT DIDN'T USE OUR INSULIN DURING HOSPITALIZATION (TOOK SALINE SOLUTION). ON (B)(6) 2022, THE PATIENT WAS DISCHARGED. ON AN UNSPECIFIED DATE, THE PATIENT SUFFERED FROM VOMITING, GIT DISTURBANCE , TOOK DANCET 8 AND THEN AGAIN DANCET 4 THE NEXT DAY(INJECTIONS) TO TREAT IT. THE PATIENT HAD HYPOTENSION (IT WAS 60/90 MM/HG). CAUSALITY FOR THE ABOVE EVENTS WERE REPORTED AS NEEDLE. THE PATIENT WAS ASKED TO RETURN THE COUNTER TO 0 AND INSERT NEW NEEDLE AND ADJUST THE COUNTER TO 4 U. THE PATIENT SAID THAT THE PEN INJECTED INSULIN NORMALLY. THE PATIENT DOESN'T SUFFER ANY OTHER MEDICAL HISTORY DISEASES AND SHE DOESN'T TAKE ANY CONCOMITANTS BESIDE INSULIN. BATCH NUMBERS: TRESIBA FLEXTOUCH U100: MP5A930. NOVOFINE , UNSPECIFIED NEEDLE: UNKNOWN. NOVORAPID PENFILL: LR7BH31. ACTION TAKEN TO TRESIBA FLEXTOUCH U100 WAS NOT REPORTED. ACTION TAKEN TO NOVORAPID PENFILL WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "HYPERGLYCEMIA(HYPERGLYCEMIA)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "PEN CANNOT DELIVER: GAP BETWEEN RUBBER PLATE AND PISTON ROD(DEVICE FAILURE)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "GIT DISTURBANCE(GASTROINTESTINAL DISORDER)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "VOMITING(VOMITING)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "HYPOTENSION(HYPOTENSION)" WAS RECOVERED. PRELIMINARY MANUFACTURER'S COMMENT: ON (B)(6) 2022: CONSIDERING THAT TRESIBA FLEXTOUCH FUNCTIONS NORMALLY WITH NEW NEEDLE, REPORTED EVENTS COULD BE RELATED TO BLOCKED NEEDLE. THE SUSPECTED FAULTY DEVICE AND NEEDLE HAS NOT BEEN RETURNED TO NOVO NORDISK FOR EVALUATION. NO CONCLUSION IS REACHED.
CASE DESCRIPTION: IT WAS REPORTED THAT PEN CANNOT DELIVER: GAP BETWEEN RUBBER PLATE AND PISTON ROD. THE PATIENT WAS ASKED TO RETURN THE COUNTER TO 0 AND INSERT NEW NEEDLE AND ADJUST THE COUNTER TO 4 U. THE PATIENT SAID THAT THE PEN INJECTED INSULIN NORMALLY. INVESTIGATION RESULTS: NAME: TRESIBA FLEXTOUCH (U100), BATCH NUMBER: MP5A930. THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. NAME: NOVORAPID PENFILL 3 ML 100IU/ML, BATCH NUMBER: LR7BH31 THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. A REFERENCE SAMPLE WAS EXAMINED MACROSCOPICALLY AND ANALYSED CHEMICALLY. THE REFERENCE SAMPLE WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DURING INVESTIGATION NO IRREGULARITIES RELATED TO THE COMPLAINT WAS DETECTED ON A REFERENCE/RESERVE SAMPLE OF THE BATCH IN QUESTION. NAME: NOVOFINE, 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 RESULTS UPDATED -B,C,D,G CODES UPDATED -RELEVANT FIELDS IN EU/CA TAB AND DEVICE ADDENDUM UPDATED -NARRATIVE UPDATED ACCORDINGLY BATCH NUMBERS: TRESIBA FLEXTOUCH U100: MP5A930 NOVOFINE , UNSPECIFIED NEEDLE: UNKNOWN NOVORAPID PENFILL: LR7BH31 ACTION TAKEN TO TRESIBA FLEXTOUCH U100 WAS NOT REPORTED. ACTION TAKEN TO NOVORAPID PENFILL WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "HYPERGLYCEMIA(HYPERGLYCEMIA)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "PEN CANNOT DELIVER: GAP BETWEEN RUBBER PLATE AND PISTON ROD(DEVICE FAILURE)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "GIT DISTURBANCE(GASTROINTESTINAL DISORDER)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "VOMITING(VOMITING)" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENT "HYPOTENSION(HYPOTENSION)" WAS RECOVERED. FINAL MANUFACTURER'S COMMENT: 07-DEC-2022: THE SUSPECTED FAULTY DEVICE (TRESIBA FLEXTOUCH) AND NOVOFINE NEEDLE 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 NOVOFINE AND TRESIBA FLEXTOUCH. CONSIDERING THAT TRESIBA FLEXTOUCH FUNCTIONS NORMALLY WITH NEW NEEDLE, REPORTED EVENTS (HYPERGLYCAEMIA) COULD BE RELATED TO INCORRECT HANDLING OF THE DEVICE LIKE NEEDLE RE-USAGE AND STORING THE DEVICE WITH NEEDLE ATTACHED. H3 CONTINUED: EVALUATION SUMMARY NAME: NOVOFINE, 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.
CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM EGYPT WAS REPORTED BY A CONSUMER AS "HYPERGLYCEMIA(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE, "PEN CANNOT DELIVER: GAP BETWEEN RUBBER PLATE AND PISTON ROD(DEVICE FAILURE)" WITH AN UNSPECIFIED ONSET DATE, "GIT DISTURBANCE(GASTROINTESTINAL DISORDER)" WITH AN UNSPECIFIED ONSET DATE, "VOMITING(VOMITING)" WITH AN UNSPECIFIED ONSET DATE, "HYPOTENSION(HYPOTENSION)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 16 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH TRESIBA FLEXTOUCH U100 (INSULIN DEGLUDEC 100 IU/ML) SOLUTION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - 42 IU, QD, SUBCUTANEOUS) (THERAPY DATES - ONGOING) FROM UNKNOWN START DATE AND ONGOING FOR "TYPE 1 DIABETES MELLITUS"; NOVOFINE, UNSPECIFIED (NEEDLE) FROM UNKNOWN START DATE FOR "TYPE 1 DIABETES MELLITUS"; NOVORAPID PENFILL (INSULIN ASPART) SOLUTION FOR INJECTION, 100 IU/ML (DOSE, FREQUENCY & ROUTE USED - 70 IU, QD, SUBCUTANEOUS) (THERAPY DATES - ONGOING) FROM UNKNOWN START DATE AND ONGOING FOR "TYPE 1 DIABETES MELLITUS", ON 01-NOV-2022 THE FOLLOWING HAS BEEN CORRECTED: SUSPECT PRODUCTS ADDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462439 | NOVOFINE | NEEDLE | FMI | NOVO NORDISK A/S | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Female | Hospitalization | NOVOPEN 4 (INSULIN DELIVERY DEVICE) |