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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Diabetic ketoacidosis [diabetic ketoacidosis], needle was malfunctioning as large amount of insulin trickles down the skin [device malfunction].Case description: this serious spontaneous regulatory authority case reported via fda (us food and drug administration), usa from the united states was reported by a pharmacist as "diabetic ketoacidosis" with an unspecified onset date, "needle was malfunctioning as large amount of insulin trickles down the skin" 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".Medical history included diabetes mellitus (type and duration not reported).On an unspecified date, the patient experienced diabetic ketoacidosis and was on the third admission to hospital for diabetic ketoacidosis.The reporter informed that the needle might be malfunctioning as large amount of insulin trickles down the skin, but no puncture wound was visible on the patient's skin despite able to hear depress and click and red flag.The batch number was available.Action taken to novofine 8mm (30g) autocover was not reported.The outcome for the event "diabetic ketoacidosis" was not reported.The outcome for the event "needle was malfunctioning as large amount of insulin trickles down the skin" was not reported.Investigation results: name: novofine autocover 30g 100 needles, batch number: 19a12u the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Microscopic examination performed.A visual examination of the reference product was performed.The needles were tested for flow with measure threads.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle.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/retain sample of the batch in question.Manufacturer comment: on 08-aug-2019: as the device (novofine 8mm (30g) autocover) 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 argus case (b)(4).Evaluation summary: name: novofine autocover 30g 100 needles, batch number: 19a12u.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Microscopic examination performed.A visual examination of the reference product was performed.The needles were tested for flow with measure threads.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle.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/retain sample of the batch in question.
Event or Problem Description
Case description: concomitant products included - levemir flexpen (insulin detemir) solution for injection,.0024 mol/l, toujeo (insulin glargine), lantus (insulin glargine), humalog (insulin lispro).On an unspecified date, the patient experienced hyperglycaemia and was on the third admission to hospital for diabetic ketoacidosis.The reporter informed that the needle might be malfunctioning as large amount of insulin trickles down the skin, but no puncture wound was visible on the patient's skin despite able to hear depress and click and red flag.Patient reported of using new needle for each injection and was removing the needle from the device after injection.On an unspecified date, the type of pen needles was changed and the patient recovered from the events.Action taken to novofine 8mm (30g) autocover was product discontinued.The outcome for the event "diabetic ketoacidosis" was recovered.The outcome for the event "needle was malfunctioning as large amount of insulin trickles down the skin" was not reported.Since last submission the case has been updated with the following: -new concomitant medications added.-the outcome for the event " diabetic ketoacidosis" was updated to "recovered" -reporter's causality was updated to "probable".-action taken to novofine 8mm (30g) autocover was updated to "product discontinued" -narrative updated accordingly.Continued: evaluation summary: name: novofine autocover 30g 100 needles, batch number: 19a12u.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Microscopic examination performed.A visual examination of the reference product was performed.The needles were tested for flow with measure threads.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle.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/retain 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: 8875206
• Report Number: 9681822-2019-00004
• Device Sequence Number: 2742683
• Product Code: FMI
• UDI-Device Identifier: 00301691852757
• UDI-Public: 00301691852757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2019

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: Other
• Device Expiration Date: 12/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 185275
• Device Lot Number: 19A12U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HUMALOG (INSULIN LISPRO); LANTUS (INSULIN GLARGINE); LEVEMIR FLEXPEN (INSULIN DETEMIR); TOUJEO (INSULIN GLARGINE)
• Outcome Attributed to Adverse Event: Hospitalization; Other