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

Model Number N/A

Device Problem Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Injection Site Reaction (4562)

Event Date 11/10/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) high blood sugar up to 29.2 mmol/l.[blood glucose increased] novopen 4 stopped injecting the required dose of the medicine [incorrect dose administered by device] the dose of the medicine leaked out some time after the needle was pulled out from the patient's skin [injection site extravasation] case description: this serious spontaneous case from (b)(6) was reported by a consumer as "high blood sugar up to 29.2 mmol/l.(blood glucose increased)" beginning on (b)(6) 2021, "novopen 4 stopped injecting the required dose of the medicine(incorrect dose administered by device)" with an unspecified onset date, "the dose of the medicine leaked out some time after the needle was pulled out from the patient's skin (injection site extravasation)" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with novopen 4 (insulin delivery device) from 2016 for "type 2 diabetes mellitus".Patient's height, weight and body mass index (bmi) was not reported.Current condition: diabetes mellitus type 2 (type and duration was not reported).Concomitant products included - protaphane hm penfill(insulin human) suspension for injection, 100iu/ml ongoing on an unspecified, patient's novopen 4 was stopped injecting the required dose of the medicine.On (b)(6) 2021, patient's blood sugar was up to 29.2 mmol/l due to the novopen 4 not delivering the required dose of insulin.On (b)(6) 2021 patient's blood sugar was reported 7.3 mmol/l.On an unspecified date, the patient reported that after inserting the needle subcutaneously and pressing push button the dose of the medicine leaked out some time after the needle was pulled out from the skin.Batch number not available action taken to novopen 4 was reported as product discontinued due to adverse event.On (b)(6) 2021 the outcome for the event "high blood sugar up to 29.2 mmol/l.(blood glucose increased)" was recovered.The outcome for the event "novopen 4 stopped injecting the required dose of the medicine(incorrect dose administered by device)" was not yet recovered.The outcome for the event "the dose of the medicine leaked out some time after the needle was pulled out from the patient's skin (injection site extravasation)" was not recovered.No further information available.

Event Description

Case description: dosage regimens: novopen 4: (b)(6) 2016 to (b)(6) 2021; investigation results: product name: novopen® 4 batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission case updated with the following information: - inv result updated.- b, c, d and g coding updated.- narrative was updated accordingly.No further information available.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.Final manufacturer's comment: 24-jan-2022: the suspected device novopen 4 has not been returned to novo nordisk and batch number is also unavailable.Batch trend analysis or reference sample analysis not performed.With limited information regarding the patients handling of the suspected device reported in the case, it is not possible to elucidate a clear root cause for functionality of novopen 4.Type 2 diabetes mellitus is assessed as risk factor for the reported event of blood glucose increased in the patient.H3 continued: evaluation summary name: novopen 4 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.

• Brand Name: NOVOPEN 4
• 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: 12923568
• MDR Text Key: 286648856
• Report Number: 9681821-2021-00084
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: 20-986
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2022
• 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: PROTAPHANE HM PENFILL (INSULIN HUMAN)
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female