MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO 3ML (GRAY); FOR TREATMENT PURPOSES

Model Number MS9699

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Numbness (2415); Coma (2417)

Event Date 06/30/2019

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.This device was associated with a diabetic hyperglycaemic coma in (b)(6) 2019, breath odour in (b)(6) 2019, and blood glucose increased on (b)(6) 2019.

Event Description

(b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog 100), from cartridge via a reusable device humapen savvio grey, thrice daily (10 units in morning, at lunch time and at night) subcutaneously for the treatment of diabetes mellitus, beginning approximately on (b)(6) 2018.Approximately in (b)(6) 2019, she experienced a hyperglycemic coma associated with recognized mouth odor due to a heavy meal.In (b)(6) 2019, she was admitted in the hospital for 2-3 hours due to the events.The events were resolved on same day and she was discharged from the hospital.Approximately on (b)(6) 2019, her humapen savvio grey got stucked and was unable to release the insulin dose.She missed two days doses however she thought the doses were successfully taken (product complaint number: (b)(4), lot number: 1311v05).Reportedly, she realized that the doses were missed through the high blood glucose level (600 mg/dl) and abdominal ache and leg numbness associated with cracking sound.The event of blood glucose of 600 mg/dl was considered as serious due to its medical significance.Since an unknown date, she started receiving insulin doses using the insulin syringe.She had not recovered from remaining events.Corrective treatment was not provided.Status of insulin lispro treatment was continued.The operator of humapen savvio grey and his/her training status was not provided.The general humapen savvio grey model duration was not provided.The suspect humapen savvio grey duration was approximately 18 months as it was started approximately on (b)(6) 2018.The status of humapen ergo ii was continued and its return was available.The initial reporting consumer did not relate the events with insulin lispro treatment.The initial reporting consumer did not relate the events of hyperglycemic coma and mouth odor and related the remaining events with humapen savvio grey.Edit 18nov2019: updated medwatch fields for expedited device reporting.No new information added.Edit 21nov2019: updated medwatch fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 12-year-old female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog 100), from cartridge via a reusable device humapen savvio grey, thrice daily (10 units in morning, at lunch time and at night) subcutaneously for the treatment of diabetes mellitus, beginning approximately on (b)(6) 2018.Approximately in (b)(6) 2019, she experienced a hyperglycemic coma associated with recognized mouth odor due to a heavy meal.In (b)(6) 2019, she was admitted in the hospital for 2-3 hours due to the events.The events were resolved on same day and she was discharged from the hospital.Approximately on (b)(6) 2019, her humapen savvio grey got stuck and was unable to release the insulin dose.She missed two days doses however she thought the doses were successfully taken (product complaint number: (b)(4), lot number: 1311v05).Reportedly, she realized that the doses were missed through the high blood glucose level (600 mg/dl) and abdominal ache and leg numbness associated with cracking sound.The event of blood glucose of 600 mg/dl was considered as serious due to its medical significance.Since an unknown date, she started receiving insulin doses using the insulin syringe.She had not recovered from remaining events.Corrective treatment was not provided.Status of insulin lispro treatment was continued.The operator of humapen savvio grey and his/her training status was not provided.The general humapen savvio grey model duration was not provided.The suspect humapen savvio grey duration was approximately 18 months as it was started approximately on (b)(6) 2018.The suspect device, which was manufactured in nov2013, was not returned to the manufacturer.The initial reporting consumer did not relate the events with insulin lispro treatment.The initial reporting consumer did not relate the events of hyperglycemic coma and mouth odor and related the remaining events with humapen savvio grey.Edit 18nov2019: updated medwatch fields for expedited device reporting.No new information added.Edit 21nov2019: updated medwatch fields for expedited device reporting.No new information added.Update 13dec2019: additional information received on 12dec2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer.Added date of manufacturer for pc (b)(4)associated with lot 1311v05 of humapen savvio (gray) device.Corresponding fields and narrative updated accordingly.Edit 16-dec-2019: upon review of the initial information received on 02-nov-2019, corrected the date of birth/age of the patient.No other changes were made to the case.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 13dec2019 in the b.5.Field.No further follow-up is planned.This device was associated with a diabetic hyperglycaemic coma in (b)(6) 2019, breath odour in (b)(6) 2019, and blood glucose increased on (b)(6) 2019.Evaluation summary: a female patient reported that her humapen savvio device became stuck and it would not release insulin.She experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1311v05, manufactured november 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to pen jammed.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAY)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 9368231
• MDR Text Key: 179545736
• Report Number: 1819470-2019-00208
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9699
• Device Lot Number: 1311V05
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 12 YR