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

Model Number	N/A
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Event verbatim [preferred term] (related symptoms if any separated by commas).High blood sugar [blood glucose increased].Pen not delivering insulin [device failure].Case description: this serious spontaneous case from the united states was reported by a consumer as "high blood sugar" beginning in (b)(6) 2017 and "pen not delivering insulin" beginning in (b)(6) 2017, and concerned a (b)(6) male patient who was treated with novopen echo (insulin delivery device) from 2017 and ongoing due to "type 1 diabetes mellitus".Medical history included type 1 diabetes mellitus (duration unknown).It was reported by patient's father that in (b)(6) 2017, the patient developed high blood sugars over 500 mg/dl due to the pen not delivering insulin.Action taken to novopen echo was reported as no change.The outcome for the event "high blood sugar" was not recovered.The outcome for the event "pen not delivering insulin" was not reported.
Event or Problem Description
Case description: investigation result: name: novopen¿ echo¿, batch number: fvga926-1 the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed.Nothing abnormal was found.Since last submission, the case has been updated with the following: investigation result added.Company/manufacturer's comment added narrative updated accordingly.Company/manufacturer's comment: 15-nov-2017: as the device novopen echo 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).Evaluation summary: novopen echo, batch number: fvga926-1 the product was not returned for examination.No abnormalities relating to the observed problem were found.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: 7029450
• Report Number: 9681821-2017-00055
• Device Sequence Number: 1005017
• Product Code: FMF
• UDI-Device Identifier: 00301691854591
• UDI-Public: 00301691854591
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: FVGA926-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 12/05/2017
• 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: Other
• Patient Age: 9 YR