MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hypoglycemic coma [hypoglycaemic coma].Dose counter of novopen most times did not move, piston rod was stuck outside the.Mechanical part [device mechanical issue].Rbgls (random blood glucose levels) are fluctuated [blood glucose fluctuation].Case description: this serious spontaneous case from egypt was reported by a consumer as "hypoglycemic coma(hypoglycemic coma)" with an unspecified onset date, "dose counter of novopen most times did not move, piston rod was stuck outside the mechanical part(device mechanical jam)" with an unspecified onset date, "rbgls (random blood glucose levels) are fluctuated(blood glucose fluctuation)" with an unspecified onset date, and concerned a 76 years old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "diabetes mellitus", mixtard 30 hm penfill (insulin human) (dose, frequency & route used-44 iu, qd (32 iu/morn.And 12 iu/night ), subcutaneous and regimen #2: unk (32 iu/morn and 10 or 8 iu/night), subcutaneous lr7bh18, 02/--/2024) from unknown start date for "diabetes mellitus".Patient's height: 159 cm, patient's weight: 70 kg, patient's bmi: 27.68877810.Current condition: diabetes (type not reported, since 1990), hypertension, hypercholesterolaemia, adjusting of heart beats.Historical drugs: tablets for diabetes (not specified) (non-codable).Concomitant products included - selokenzoc(metoprolol succinate), amlodipine, downsterolin(ezetimibe, simvastatin).On an unknown date patient's rbgl's (random blood glucose levels) were fluctuated (40 mg/dl in case of hypoglycaemia and not exceed 260 mg/dl in case of hyperglycaemia, although her normal rbgls ranged 130-150 mg/dl).On an unknown date patient complained that the dose counter of her novopen 3 most times did not move after adjusting the dose and if so, it moved only for few dose numbers from the adjusted 32 iu.Pen training was offered and during it the piston rod was stuck outside the mechanical part even after confirming that the pen was not kept inside the refrigerator and trying to rotate the piston rod manually.On an unknown date, patient experienced hypoglycemic coma more than one time and could only confirm the date of the last one which was 1 week ago from 05 to 11 pm which was treated only by having molasses and juice without requiring of medical intervention), reported that the improper amount of food taken on breakfast or lunch or longing time to have meal after the dose may contribute the occurrence of hypoglycemia.Batch numbers: novopen 3: tug0326 (non valid), mixtard 30 hm penfill: lr7bh18.Action taken to mixtard 30 hm penfill was reported as dose decreased.The outcome for the event "hypoglycemic coma(hypoglycemic coma)" was recovered.The outcome for the event "dose counter of novopen most times did not move, piston rod was stuck outside the mechanical part(device mechanical jam)" was not reported.The outcome for the event "rbgls (random blood glucose levels) are fluctuated(blood glucose fluctuation)" was not reported.References included: reference type: e2b linked report, reference id#: (b)(4), reference notes: same patient case.

Event Description

Case description: investigation result : name: novopen® 3 batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: mixtard® 30 penfill® 3 ml 100iu/ml, batch number: lr7bh18.The product was not returned for examination.Since last submission, this case has been updated with the following: investigation result added; imdrf code added; relevant fields updated in eu/ca tab; narrative updated accordingly.References included: reference type: e2b linked report; reference id#: (b)(4); reference notes: same patient case.Final manufacturer's comment: 15-may-2023: the suspected device (novopen 3) has not been returned to novo nordisk a/s for the investigation.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 3.Elderly age of the patient (76 years), long-standing diabetes and change in food intake (the improper amount of food taken on breakfast or lunch or longing time to have meal after the dose) are significant confounding factors for the development of hypoglycaemic coma and blood glucose fluctuation.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 hm penfill.Reporter comment: patient's causality for both events are unlikely, but she added that the improper amount of food taken on breakfast or lunch or longing time to have meal after the dose may contribute the occurrence of hypoglycemia.

• Brand Name: NOVOPEN 3
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed,, 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 16520032
• MDR Text Key: 311045805
• Report Number: 9681821-2023-00035
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: 19-938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AMLODIPINE (AMLODIPINE) ONGOING.; DOWNSTEROLIN (EZETIMIBE, SIMVASTATIN) ONGOING.; SELOKENZOC (METOPROLOL SUCCINATE) ONGOING.
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 70 KG