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

Model Number N/A

Device Problem No Flow (2991)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Injury (2348); No Code Available (3191)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) grief and suffering [emotional distress], pressure damages to body parts on a constant bases [injury], finding it hard to keep control due to faults via your pens [blood glucose fluctuation], hypos [hypoglycaemia], fault by pen [device issue], high sugar levels [blood glucose increased].Case description: this serious spontaneous regulatory authority case from the (b)(6) was reported by a consumer as "grief and suffering", "pressure damages to body parts on a constant bases ", "finding it hard to keep control due to faults via your pens", "hypos", "high sugar levels" and "fault by pen", all with an unspecified onset date and concerned a (b)(6) male patient who was treated with suspect drug levemir penfill (insulin detemir), suspect drug novorapid penfill (insulin as part) and exposed to suspect device novopen 4 blue (insulin delivery device) (concerning 4 different batches) and suspect device novopen 4 silver (insulin delivery device) (concerning 2 different batches) from unknown start date due to "diabetes mellitus".Medical history included diabetes mellitus in nearly 48 years.Patient's height, weight and bmi were not reported.The patient found it hard to keep his blood glucose in control due to faults with the suspected novo nordisk products.He experienced hypos and high sugars levels.Furthermore, the patient reported that due to his uncontrolled diabetes and issues with novo nordisk products, he experienced grief, suffering and pressure damages to his body parts on constant bases.The patient also experienced nerve damage.The courses of the event, lab tests, treatment of the events, onset and stop dates were not reported.However the patient stated that the mentioned problems have been over 5 years or longer.According to the patient the novopen 4's were jamming up and air was going into him.The novopens 4 jammed up too often over the 5 years.The patient did not know if he received insulin.The patient was also noticing changes, when changing over to a different batch, or there was something else, which was unknown to the patient.The patient was getting them jamming in the middle of injecting too.It was reported that the plastic spirals are not good enough or varied in the productions or there might be slight differences in the insulins delivery which could still make a difference to sugar levers.In addition the patient also complained about novo nordisk levemir and novo rapid flexpen (captured in (b)(4)) with similar issues.The patient was seeing patterns in his blood readings and also reported that he might not receive the insulin.Action taken to levemir penfill was not reported.Action taken to novorapid penfill was not reported.Action taken to novopen 4 blue and silver was reported as product discontinued, as the patient stated, that he had come off novopen 4's.The outcome for the event "grief and suffering" was not reported.The outcome for the event "pressure damages to body parts on a constant bases" was not reported.The outcome for the event "finding it hard to keep control due to faults via your pens" was not reported.The outcome for the event "hypos" was not reported.The outcome for the event "fault by pen" was not reported.The outcome for the event "high sugar levels" was not reported.Linked (b)(4).

Event Description

Case description: no further information is expected, as the patient refused to be contacted.Investigation/results: novopen 4: batch: aug0884, bug1544, cug1200, aug1498, cug0871 and dug0978 - a batch trend report has been created.Nothing abnormal was found.The products were not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.Nothing abnormal was found.No irregularities related to adr "hyperglycemia" and adr "hypoglycemia" were found in the batch record review.Number of novopen 4 supplied in:~ previous 12 months: (b)(4).Last 3 years: (b)(4).Since last submission the case has been updated with the following: investigational result on novopens.Risk assessment and final manufacturer comment.Number of novopen supplied in (b)(4).Narrative updated accordingly.Risk assessment: on (b)(6) 2016: the patient complained that he had troubles with controlling his blood glucose and that his novopen 4 pens jammed over a period of 5 years.The suspected pens have not been returned to novo nordisk for investigation, but the batch numbers for the pens were provided.A batch record review of all suspected batches did not disclose anything abnormal.As limited information on how the patient handled the pens were reported and the pens were not returned for investigation, it is thus not possible to identify a root-cause and perform a proper assessment of the risk.Final manufacturer comment on (b)(6) 2016: in this case, the patient has complaint of several novo nordisk insulin products, both as penfill used together with durable device novopen4 and disposable pens (flexpen - captured in linked case (b)(4) in a period of at least 5 years.Treatment of diabetes depends on different factors such as diet, physical activity and medication.Dosing of insulin is individual and determined in accordance with the needs of the patient.A close blood glucose monitoring is required in order to keep the blood glucose within the acceptable ranges.With current provided information in the case and normal investigation result of the suspected batches, it is not possible to conclude a causal relationship between the suspected products and the reported events.Evaluation summary: aug0884 - novopen 4 inv-(b)(4): a batch trend report has been created.Nothing abnormal was found.The product was not returned for examination.If possible, please forward the sample(s) in question for further investigations.Inv-(b)(4): the batch documentation was reviewed.No irregularities related adr: hyperglycemia and adr: hypoglycemia were found in the batch record review.The batch documentation has been reviewed.Nothing abnormal was found.Bug1544 - novopen 4 inv-(b)(4): a batch trend report has been created.Nothing abnormal was found.The product was not returned for examination.If possible, please forward the sample(s) in question for further investigations.Inv-(b)(4): the batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed.Nothing abnormal was found.Inv-(b)(4): the batch documentation was reviewed.No irregularities related to adr: hyperglycemia and adr: hypoglycemia were found in the batch record review.The batch documentation has been reviewed.Nothing abnormal was found.Dug0978 - novopen 4 inv-(b)(4): a batch trend report has been created.Nothing abnormal was found.The product was not returned for examination.If possible, please forward the sample(s) in question for further investigations.Inv-(b)(4): the batch documentation was reviewed.No irregularities related to adr: hyperglycemia and adr: hypoglycemia were found in the batch record review.The batch documentation has been reviewed.Nothing abnormal was found.Cug1200 - novopen 4 inv-(b)(4): a batch trend report has been created.Nothing abnormal was found.The product was not returned for examination.If possible, please forward the sample(s) in question for further investigations.Inv-(b)(4): the batch documentation was reviewed.No irregularities were found in the batch record review.The batch documentation has been reviewed.Nothing abnormal was found.Aug1498 - novopen 4 inv-(b)(4): a batch trend report has been created.Nothing abnormal was found.The product was not returned for examination.If possible, please forward the sample(s) in question for further investigations.Inv-(b)(4): the batch documentation was reviewed.No irregularities related to adr: hyperglycemia and adr: hypoglycemia were found in the batch record review.The batch documentation has been reviewed.Nothing abnormal was found.Cug0871 - novopen 4 inv-(b)(4): a batch trend report has been created.Nothing abnormal was found.The product was not returned for examination.If possible, please forward the sample(s) in question for further investigations.Inv-(b)(4): the batch documentation was reviewed.No irregularities were found in the batch record review.The batch documentation has been reviewed.Nothing abnormal was found.Unknown - novorapid penfill 3 ml no investigation was possible, be.Cause neither sample nor batch number was available.Unknown - levemir penfil l 3 ml.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; 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: 5569590
• MDR Text Key: 42425885
• Report Number: 9681821-2016-00012
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2016
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: AUG1498
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2011
• 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 Age: 50 YR