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

Model Number	N/A
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Codes	Unspecified Infection (1930); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	11/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Infection.Acute diabetic ketosis complicated by an infection.Echo pen not delivering his medication (possibly a calibration issue).[device issue].I was on vacation and do not know if the insulin was stored correctly.Case description: this serious spontaneous case from the united states was reported by a general physician as "acute diabetic ketosis ", " infection", "novoecho pen did not deliver insulin, maybe the calibration stopped working", "i was on vacation and do not know if the insulin was stored correctly" all beginning on (b)(6) 2016, and concerned a (b)(6) male patient who was treated with levemir (insulin detemir) from 2014 and ongoing due to "type 1 diabetes mellitus", novolog penfill (fast acting insulin aspart) from unknown start date and ongoing due to "type 1 diabetes mellitus" and novopen echo (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus".Patient's height, weight and body mass index (bmi) were not reported.Medical history included type 1 diabetes mellitus (duration not reported).Treatment drugs included dextrose (glucose) and saline (sodium chloride).It was reported that the patient was on vacation during end of(b)(6) 2016 and he experienced high blood glucose levels.The patient felt that echopen was not delivering medication (possibly a calibration issue) and also mentioned that insulin was incorrectly stored while he was on vacation.It was reported that on (b)(6) 2016, the patient was hospitalized with blood glucose levels of 600 mg/dl for two night and 3 days.While the patient was in hospital, he was diagnosed with acute diabetic ketosis complicated by an infection.The patient was treated with intravenous dextrose and saline with insulin.Action taken to levemir was reported as no change.Action taken to novolog penfill was reported as no change.Action taken to novopen echo was not reported.On (b)(6) 2016 the outcome for the event "acute diabetic ketosis " was reported as recovered.The outcome for the event "novolog echo pen did not deliver insulin, maybe the calibration stopped working" was not reported.The outcome for the event "i was on vacation and do not know if the insulin was stored correctly" was not reported the outcome for the event "infection" was reported as not reported reporter comment: although the patient felt that the high blood sugars were due to using novolog and levemir, he also stated that it could have been due to an infection, having diabetes for such a long time, the echopen not delivering his medication (possibly a calibration issue), or due to possible incorrect storage temperature of his insulin while on vacation.
Event or Problem Description
Case description: investigation results: name: novopen echo.Batch number: ev40038.The product was not returned for examination.The batch documentation and non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.Since last submission the case was updated with the following information: - suspect device expiration date added.- investigation results were added.- manufacturer comment added.Manufacturer comment: received 03-mar-2017: as the novoecho pen has not been returned to novo nordisk a/s for investigation and only very 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).Continued: evaluation summary: name: levemir®, 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.Name: novolog® penfill® 3 ml cartridges 100 units/ml (u-100), 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.Name: novopen® echo®, batch number: ev40038.(b)(4): the product was not returned for examination.If possible, please forward the reported product(s) for further investigations.The complaint has been registered in the novo nordisk complaint handling system.(b)(4): the batch documentation and non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.

• Brand Name: NOVOPEN ECHO
• Common Device Name: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 6286082
• Report Number: 9681821-2017-00005
• Device Sequence Number: 10925265
• Product Code: FMF
• UDI-Device Identifier: 00301691854591
• UDI-Public: 00301691854591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/11/2017
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: EV40038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 77 YR