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

Model Number	N/A
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(related symptoms if any separated by commas), blood sugar over 400-500 mg/dl [blood glucose increased], pen needing to be primed up to 5 times before any insulin comes out of the pen [device difficult to use], blood sugars not able to get under 400-500 mg/dl due to particular batch [product quality issue].Case description: this serious spontaneous case from the (b)(6) was reported by a consumer as "blood sugar over 400-500 mg/dl(blood glucose increased)" beginning on (b)(6) 2020, "pen needing to be primed up to 5 times before any insulin comes out of the pen(device difficult to use)" beginning on (b)(6) 2020, "blood sugars not able to get under 400-500 mg/dl due to particular batch(product lot specific issue)" beginning on (b)(6) 2020, and concerned a (b)(6) female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", novolog penfill (insulin aspart) from (b)(6) 2020 and ongoing for "type 1 diabetes mellitus" (dose and frequency sliding scale).The patient's height, weight and body mass index (bmi): not reported.Dosage regimens: novopen echo: novolog penfill: (b)(6) 2020 to not reported (dosage regimen ongoing).Current condition: type 1 diabetes mellitus (duration : not reported).On (b)(6) 2020, the patient had blood sugar over 400-500 mg/dl.Patient's mother reported the patient receiving therapy with novolog penfill cartridges and novopen echo was unable to get the blood sugars under 400-500 mg/dl.The mother reported being unable to get the blood sugar under 400 mg/dl when the patient was home, but the patient's blood sugar was fine during school.The mother reported the blood sugars were high with the particular batch and that she would need to prime the novopen echo up to 5 times before any insulin would come out of the pen.Batch numbers of novopen echo is jvgr852-7.Batch numbers of novolog penfill is hs67e16.Action taken to novopen echo was not reported.Action taken to novolog penfill was not reported.The outcome for the event "blood sugar over 400-500 mg/dl(blood glucose increased)" was not recovered.The outcome for the event "pen needing to be primed up to 5 times before any insulin comes out of the pen(device issue)" was not reported.The outcome for the event "blood sugars not able to get under 400-500 mg/dl due to particular batch(product lot specific issue)" was not reported.
Event or Problem Description
Case description: the outcome for the event "pen needing to be primed up to 5 times before any insulin comes out of the pen(device difficult to use)" was not reported.Investigation results: name: novopen echo batch number jvgr852-7 the product was not returned for examination.Name: novolog® penfill® 3 ml cartridges 100 units/ml (u-100) - batch hs67e16 the product was not returned for examination.Since last submission the case has been updated with the following information: -investigational results updated.-manufacturer comment updated.-narrative updated accordingly.Manufacturer comment: 19-mar-2020: 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.Considering that blood glucose was fine at school, but not well controlled at home, it could be related to batch of insulin and training of the person who is administering the insulin at home.H3 continued: evaluation summary novopen echo batch number jvgr852-7 the product was not returned for examination.

• Brand Name: NOVOPEN ECHO
• Common Device Name: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 9828718
• Report Number: 9681821-2020-00015
• Device Sequence Number: 743237
• Product Code: FMF
• UDI-Device Identifier: 00301691854591
• UDI-Public: 00301691854591
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: JVGR852-7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: 8 YR