MAUDE Adverse Event Report: NOVO NORDISK A/S, MS HJOERRING NOVOFINE PLUS 4MM (32G); NEEDLE

Model Number	N/A
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Event verbatim [preferred term] (related symptoms if any separated by commas); high blood sugars of 500mg/dl [blood glucose increased]; needle is bending when he injects himself [needle issue]; needle was clogging up [needle issue]; not getting his insulin [device failure].Case description: this serious spontaneous case from the united states was reported by a consumer as "high blood sugars of 500mg/dl" beginning on (b)(6) 2018, "needle is bending when he injects himself" beginning on (b)(6) 2018, "needle was clogging up" beginning on (b)(6) 2018, "not getting his insulin" beginning on (b)(6) 2018, and concerned a (b)(6) years old male patient who was treated with novofine plus 4mm (32g) (needle) from (b)(6) 2018 and ongoing due to "type 2 diabetes mellitus".Patient height, weight and body mass index was not reported.Medical history included type 2 diabetes mellitus, cancer, and diabetic neuropathy.It was reported that patient was using 30 gauge needles (unspecified) which were discontinued on an unknown date.On (b)(6) 2018, the needle was bending or clogging up and not letting insulin get through the patient's skin.The patient had blood glucose of 500mg/dl, due to not getting his insulin.The patient went to the emergency room but was not hospitalised, received more insulin and returned home on an unknown date.Action taken to novofine plus 4mm (32g) was reported as no change.Batch number was available.The outcome for the event "high blood sugars of 500mg/dl" was not recovered.The outcome for the event "needle is bending when he injects himself" was not reported.The outcome for the event "needle was clogging up" was not recovered.The outcome for the event "not getting his insulin" was not reported.Investigation results: name: novofine plus 32g x 4mm, batch number: 17l07n the complaint has been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Microscopic examination performed.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle.The needles tested for flow with measure threads.A visual examination of the back needle of the returned product was performed.An examination of a reference sample showed nothing abnormal.During investigation it has not been possible to detect any irregularities related to the complaint on a reference sample of the batch in question.Manufacturer comment: 18-dec-2018: as the device (novofine plus 4mm) 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: name: novofine plus 32g x 4mm, batch number: 17l07n.The complaint has been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Microscopic examination performed.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle.The needles tested for flow with measure threads.A visual examination of the back needle of the returned product was performed.An examination of a reference sample showed nothing abnormal.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 PLUS 4MM (32G)
• Common Device Name: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S, MS HJOERRING; hjoerring, ; DA
• MDR Report Key: 8211179
• Report Number: 9681822-2019-00001
• Device Sequence Number: 2016185
• Product Code: FMI
• UDI-Device Identifier: 00301691855505
• UDI-Public: 00301691855505
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133738
• 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
• Report Date (Section B): 12/06/2018

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: 11/16/2022
• Device Model Number: N/A
• Device Catalogue Number: 185550
• Device Lot Number: 17L07N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: 75 YR