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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 10/09/2015

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) the patient found in coma after about one hour with blood glucose level 34 mg/dl [hypoglycaemic coma].Both pens which were used by patient are damaged [device damage].Administered by mistake 29 u of insulin instead of 19 u [accidental overdose].Spring hides during cartridge insertion and has to push the button several times to move the spring to the cartridge [device malfunction].Case description: this serious spontaneous case from poland was reported by a consumer as "the patient found in coma after about one hour with blood glucose level 34 mg/dl" and "administered by mistake 29 u of insulin instead of 19 u" both beginning on (b)(6) 2015 and "both pens which were used by patient are damaged" and "spring hides during cartridge insertion and has to push the button several times to move the spring to the cartridge" all with an unspecified onset date and concerned a (b)(6) year-old female patient who used two suspect novopens (insulin delivery device) both from unknown start date for about 2 to 3 years and treated with co-suspect insulin (insulin) from unknown start date since 8 to 9 years all for type 2 diabetes mellitus.Patient's height, weight and body mass index: not reported.Medical history included type 2 diabetes mellitus (duration not reported).Recommended insulin dose was 19 u.On (b)(6) 2015 at the morning, the patient had problem with inserting cartridge into the pen.The patient thought that she had inserted the cartridge in correct way, but was not sure as she did not remember further activities.The patient administered insulin by herself.It was reported in the follow up, that probably the patient administered by mistake 29 u of insulin instead of 19 u.The patient was found in coma after about one hour with blood glucose level 34 mg/dl.Units were originally not reported by the reporter; however units in poland usually used for blood glucose levels are mg/dl.It was reported that the patient was hospitalized due to incorrect administration of insulin.It was also reported that both the pens used by the patient were damaged, but it was not clear if the event and incorrect administration was caused by pen damage.Currently patient's test results and health condition were good.Upon further follow up, it was reported that technical complaint concerns mainly the spring in the novopen.The spring hides during cartridge insertion or when the position of cartridge is corrected.The patient had to push the button several times to move the spring to the cartridge and start pushing the piston rod head.The reporter underlined that for elderly people that is a problem as it is uncertain if insulin was administered or not.After 2 weeks of observation, the patient's physician (specialist - diabetologist) recommended discontinuation of insulin administration and instead the patient takes metformin tablets, as the patient lost about 15 kg within recent year (it is about (b)(6) of starting weight) and takes care of diet with a low glycaemic index.Action taken to insulin and both novopens was discontinued.The outcome for the event "the patient found in coma after about one hour with blood glucose level 34 mg/dl" was recovered.The outcome for the event "both pens which were used by patient are damaged" was not reported.The outcome for the event "administered by mistake 29 u of insulin instead of 19 u" was not reported.The outcome for the event "spring hides during cartridge insertion and has to push the button several times to move the spring to the cartridge" was not reported.Investigation results novopen - batch unknown.No investigation was possible, because neither sample nor batch number was available.Novopen - batch unknown.No investigation was possible, because neither sample nor batch number was available.Insulin- batch unknown.No investigation was possible, because neither sample nor batch number was available.Manufacturer's final comment: on (b)(6) 2015: hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.In this case, it was reported that the patient took 29u instead of 19u, which is considered as plausible explanation of the event.As the novopens have not been returned to novo nordisk a/s for investigation and only limited information regarding the handling of suspected device is 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: novopen - batch unknown.No investigation was possible, because neither sample nor batch number was available.

Event Description

Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "the patient found in coma after about one hour with blood glucose level 34mg/dl" and "administered by mistake 29 u of insulin instead of 19 u" both beginning on (b)(6) 2015 and "both pens which were used by patient are damaged" and "spring hides during cartridge insertion and has to push the button several times to move the spring to the cartridge" both with an unspecified onset date and concerned a (b)(6) female patient who used two novopen (insulin delivery device) both from unknown start date for about 2 to 3 years and treated with insulin (insulin) from unknown start date since 8 to 9 years all for type 2 diabetes mellitus.Action taken to insulin and both novopens was reported as product discontinued.Since last submission the case has been updated with the following : - narrative updated accordingly - final manufacturer's comment updated.Manufacturer's final comment: (b)(6) 2015: hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.In this case, it was reported that the patient took 29u instead of 19u, which is considered as plausible explanation of the event.As the novopens have not been returned to novo nordisk a/s for investigation and only limited information regarding the handling of suspected device is 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 argus (b)(4).

• Brand Name: NOVOPEN
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: novoprod novo nordisk inc. ; p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 5302273
• MDR Text Key: 33701057
• Report Number: 9681821-2015-00041
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K861686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/11/2015

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: 185230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• 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): Hospitalization
• Patient Age: 75 YR