MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Fracture (1260); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) increased blood glucose values up to 550 mg/dl [blood glucose increased].Penfill holder was cracked [device breakage].Too little insulin was delivered during injection [device delivery system issue].Case description: this serious spontaneous case from germany was reported by a consumer as "increased blood glucose values up to 550 mg/dl (blood glucose increased)" with an unspecified onset date, "penfill holder was cracked(device cracked)" with an unspecified onset date, "too little insulin was delivered during injection(inaccurate delivery by device)" with an unspecified onset date, and concerned a male patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy", the patient's height, weight and body mass index (bmi) were not reported.Medical history was not provided.A patient reported that he experienced increased blood glucose values up to 550 mg/dl during use of novopen 5.The penfill holder was cracked and therefore too little insulin was delivered during injection.The reporter does not want to provide further information and does not want to receive a reporting form.Batch number of novopen 5: cug2200.The outcome for the event "increased blood glucose values up to 550 mg/dl(blood glucose increased)" was not reported.The outcome for the event "penfill holder was cracked(device cracked)" was not reported.The outcome for the event "too little insulin was delivered during injection(inaccurate delivery by device)" was not reported.(b)(4) case no.(b)(4).No further information was available.

Event Description

Case description: investigation result: novopen® 5, batch number: cug2200.The product was not returned for examination.Since last submission the following has updated in the case: investigation result added.Imdrf code added.Narrative updated accordingly.No further information was available.References included: reference type: e2b company number.Reference id#: de-novoprod-1025709.Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.Reference type: e2b report duplicate.Reference id#: (b)(4).Reference notes: bfarm case no.Final manufacturer's comment: 28-mar-2023: the suspected device novopen 5 has not been returned to novo nordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.No other confounding factors identified.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 5.H3 continued: evaluation summary.Novopen® 5, batch number: cug2200.The product was not returned for examination.

• Brand Name: NOVOPEN 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; 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: 16476276
• MDR Text Key: 310590976
• Report Number: 9681821-2023-00029
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123766
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Model Number: N/A
• Device Lot Number: CUG2200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• 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
• Patient Outcome(s): Other
• Patient Sex: Male