MAUDE Adverse Event Report: NOVO NORDISK A/S, MS HJOERRING NOVOFINE 8MM (30G)AUTOCOVER; NEEDLE

Model Number	N/A
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/16/2018
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].Novofine 30 autocover needles not releasing enough insulin [incorrect dose administered by device].Novofine 30 autocover needles not releasing enough insulin [device issue].Case description: this serious spontaneous case from the united states was reported by a consumer as "high blood sugar" beginning on (b)(6) 2018, "novofine 30 autocover needles not releasing enough insulin" with an unspecified onset date, novofine 30 autocover needles not releasing enough insulin" with an unspecified onset date and concerned a female patient (age not reported) who was treated with novofine 8mm (30g) autocover (needle) from unknown start date due to "device therapy", a non-novo nordisk suspect product lantus (insulin glargine) from an unknown start date due to an unknown indication (dose and frequency unknown).Patient's height, weight and body mass index was not reported.Medical history was not provided.The patient usually used novofine 30g needles.On an unknown date, the patient started using novofine 8mm (30g) autocover.It was reported that novofine 30 autocover needles did not release enough insulin.On (b)(6) 2018, the patient had high blood glucose of 503 mg/dl.Action taken to novofine 8mm (30g) autocover was not reported.Action taken to lantus was not reported.The outcome for the event "high blood sugar" was not reported.The outcome for the event "novofine 30 autocover needles not releasing enough insulin" was not reported.The outcome for the event "novofine 30 autocover needles not releasing enough insulin" was not reported.Reporter comment: pharmacy gave her novofine autocover, she doesn't like them and doesn't want to use them.Reporter was attributing the high blood sugar of 503 mg/dl to the novofine 30 autocover needles.
Event or Problem Description
Case description: investigational result: product name: novofine autocover 30g 100 needles batch number: 18c13u the product was not returned for examination.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle the needles tested for flow with measure threads.Cl: reference sample on adr/ae was found to be normal during investigation it has not been possible to detect any irregularities related to the complaint on a reference sample of the batch in question.Since last submission, case has been update with the following: - investigational results were updated for novofine autocover 30g 100 needles - manufcaturer's comment updated - narrative updated accordingly.Manufacturer's comment/company comment: 03-oct-2018: as the device novofine 8mm (30g) autocover has not been returned to novo nordisk a/s for investigation and 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 argus case 617169.The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novofine 8mm (30g)autocover.H3 continued: evaluation summary product name: novofine autocover 30g 100 needles batch number: 18c13u the product was not returned for examination.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle the needles tested for flow with measure threads.Cl: reference sample on adr/ae was found to be normal during investigation it has not been possible to detect any irregularities related to the complaint on a reference sample of the batch in question.

• Brand Name: NOVOFINE 8MM (30G)AUTOCOVER
• Common Device Name: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S, MS HJOERRING; hjoerring, ; DA
• MDR Report Key: 7873930
• Report Number: 9681822-2018-00004
• Device Sequence Number: 1909426
• Product Code: FMI
• UDI-Device Identifier: 00301691852979
• UDI-Public: 00301691852979
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050106
• 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): 08/17/2018

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: 02/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 185275
• Device Lot Number: 18C13U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/30/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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