MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Partial Blockage (1065); Fracture (1260); Failure to Eject (4010)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Event Description

Hyperglycemic coma [diabetic hyperglycaemic coma], novopen sometimes did not inject the insulin [device malfunction], the dose button during injection became hard [device difficult to use], the cartridge holder was broken at the side of the mechanical part [device breakage], mixtard in use was stored in refrigerator [product storage error].This serious spontaneous case from (b)(6) was reported by a consumer as "hyperglycemic coma (coma hyperglycemic)" with an unspecified onset date, "novopen sometimes did not inject the insulin(device malfunction)" with an unspecified onset date, "the dose button during injection became hard(device difficult to use)" with an unspecified onset date, "the cartridge holder was broken at the side of the mechanical part(device breakage)" with an unspecified onset date, "mixtard in use was stored in refrigerator(improper storage of product in use)" with an unspecified onset date and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", mixtard 30 hm penfill (insulin human) suspension for injection, 100 iu/ml, dose, frequency & route used- #1: 85 iu, qd(dose 60 iu morning- 25 iu night), subcutaneous, regimen #2: twice 10 iu corrective dose then another 10 iu, subcutaneous, jr71r07 02/--/2022, regimen #3: unk, subcutaneous ongoing, jr71r07 02/--/2022 from unknown start date and ongoing for "diabetes mellitus", the patient's height, weight and body mass index were not reported.Current condition: diabetes mellitus, hypertension.Concomitant products included - concor(bisoprolol fumarate).On an unknown date (reported as 15 ot 16 ramadan), the patient experienced coma(hyperglycemic) due to problem with novopen as the pen sometimes did not inject the insulin.2 or 3 days later, the same event repeated so another person helped the patient to take a corrective dose (treatment) from mixtard 30 penfill twice 10 iu and then another 10 iu so the patient recovered and became conscious.On unspecified date (reported as 21 or 22 ramadan), the patient stopped using novopen 4 and used mixtard 30 by syringes.The patient's random blood glucose(rbg) was always above 300 and last 15 days it was above 500 mg/dl.The fasting blood glucose(fbg) was 360mg/dl(during the event) and post prandial blood glucose(ppbg) was 520mg/dl (during the event).The glycosylated hemoglobin(hba1c) was high(results unknown) done 5months ago it was reported that pen sometimes did not inject the insulin although backing of the dose counter to zero and the pressing on the dose button during injection became hard.The cartridge holder was broken at the side of the mechanical part and the two parts of the pen close well.It was reported that patient stored the mixtard 30 penfill in use in refrigerator and novopen 4 was not stored at room temperature.The patient in general reused needles and kept the needle attached to the pen in between injections.The patient was trained by health care professional in the use of novopen 4 and was the operator of the device at the time of event.The patient had not recently changed from another novopen to the current novopen.The patient resuspended the insulin before use.Patient suffered from hyperglycaemia and coma 15 days ago and completely recovered after replacing the pen with syringe.Batch numbers: novopen 4: duk0976, mixtard 30 hm penfill: jr71r07.Action taken to novopen 4 was reported as product discontinued due to ae.Action taken to mixtard 30 hm penfill was not reported.The outcome for the event "hyperglycemic coma (coma hyperglycemic)" was recovered.The outcome for the event "novopen sometimes did not inject the insulin(device malfunction)" was not reported.The outcome for the event "the dose button during injection became hard(device difficult to use)" was not reported.The outcome for the event "the cartridge holder was broken at the side of the mechanical part(device breakage)" was not reported.In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The disassembled medical device will be stored with the same retention period as other complaint samples.Preliminary manufacturer's comment: on 28-may-2021: the suspected device has not been returned to novo nordisk for evaluation.No conclusion is reached.The other confounding factors reported which could have contributed to hyperglycemic coma are improper storage of the insulin and uncontrolled diet.Reporter comment: medical confirmation unavailable within health care professional (hcp) who was contacted, as the patient didn't visit hcp recently so couldn't confirm if adverse event (ae) occurred with the patient or not.Alternative causes related to adverse event: may be due to improper storage of the insulin by the patient,uncontrolled diet, the patient may take the prescribed doses but the hcp didn't confirm the exact cause of ae hyperglycaemic coma with this patient.

Event Description

Case description: investigation result: novopen 4 - batch dug0976.The product was not returned for examination.The batch documentation has been reviewed and found to be normal.Mixtard 30 penfill 3 ml 100iu/ml - batch jr71r07.The product was not returned for examination.A reference sample was examined macroscopically, microscopically and analysed chemically.The results were found to comply with specifications.Since last submission, the case updated with the following information: -investigation result updated.-final report checked.-b, c, d, g codes updated.-manufacturer's comment updated.-narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: the suspected device (novopen 4) has not been returned to novo nordisk a/s for the investigation.The batch trend analysis and reference sample examination revealed nothing abnormal.No abnormalities relating to the observed problem were found.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, uncontrolled diet and improper storage of insulin could have contributed to hyperglycaemia and its complications.Company comment: reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 penfill.H3 continued: evaluation summary: investigation result: novopen 4 - batch dug0976.The product was not returned for examination.The batch documentation has been reviewed and found to be normal.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11968186
• MDR Text Key: 267541544
• Report Number: 9681821-2021-00024
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2016
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: DUG0976
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONCOR (BISOPROLOL FUMARATE) TABLET ONGOING.
• Patient Outcome(s): Life Threatening