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

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).High blood sugar 30mmol/l [blood glucose increased].Piston rod has fell off and insulin was not coming out [device failure].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "high blood sugar 30mmol/l" with an unspecified onset date, "piston rod has fell off and insulin was not coming out" with an unspecified onset date, and concerned a female patient (age not reported) who was treated with insulin (name unspecified) from unknown start date for unknown indication and with novopen 4 silver (insulin delivery device) from unknown start date as device therapy.Patient's height, weight and bmi not reported.Medical history was not provided.It was reported that the piston rod had fell off.She realized that the insulin was not coming out.Patient did not receive her dose and her blood sugar readings were up to 30mmol/l.Patient would return the pen for investigation but she informed it was not a manufacturing defect.She used the pen for about 6months.Action taken to insulin and novopen 4 was not reported.The outcome for the event "high blood sugar 30mmol/l" was not reported.The outcome for the event "piston rod has fell off and insulin was not coming out" was not reported.No further information available.

Event Description

Case description: investigation result: name: novopen® 4 silver, batch: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following: -investigation result, -manufacturer comment added.Manufacturer comment: update 05-jan-2017: as the novopen 4 silver has not been returned to novo nordisk (b)(4) for investigation and only very limited information regarding the handling of suspected device available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in (b)(4).Evaluation summary: no investigation was possible, because neither sample nor batch number was available.

• 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: novoprod novo nordisk inc. ; p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 6198617
• MDR Text Key: 63105601
• Report Number: 9681821-2016-00043
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• 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: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• 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
• Patient Outcome(s): Other