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

Model Number MS9699

Device Problem Infusion or Flow Problem (2964)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912); Inflammation (1932); Coma (2417)

Event Date 12/31/2019

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.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer via patient support program (psp), concerned a (b)(6) year-old female patient of unknown ethnicity.Medical history included thyroid gland disorders.Concomitant medications included amlodipine besilate / hydrochlorothiazide / olmesartan medoxomil for hypertension, levothyroxine sodium for thyroid gland disorders and other unspecified medication for gastric disorders and gallbladder inflammation.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) via reusable pen (humapen savvio gray) from 30 to 40 international units (iu) in the morning and 15 to 20 iu each evening, subcutaneously, for diabetes mellitus beginning approximately in 2016.In (b)(6) 2019, she was hospitalized due to a diabetic coma from a low blood glucose level (no values, units or reference ranges provided).After her blood glucose level returned to normal and recovered from the events she was discharged.No more details of corrective treatment or laboratory tests done while hospitalized were provided.Additionally, since (b)(6) 2019, she had been experiencing difficulty to inject insulin with her humapen savvio, the injection button sometimes got stuck and she was not sure if she was taking the right dose, and since then, her blood glucose levels were in the range of 400 mg/dl (product complaint (b)(4)/lot number 1308v07).On unspecified dates, she began to experience gastric disorders, gallbladder inflammation and, she experienced hypertension for a year but it was controlled.The outcome of remaining event was not resolved.Insulin lispro protamine suspension 75%/ insulin lispro 25% therapy status was ongoing.The patient was the operator of the device, but her training status was not provided.The general model duration of use was approximately of four years, but the suspect device model duration of use was unknown.Information regarding improper use of the device, improper storage, device status or action taken was not provided.The reporting consumer assessed the events as not related to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy, but assessed the events wrong dose, blood glucose increased and diabetic coma as related to the device.Also, she assessed the event gastric disorder to taking a lot of unspecified medications.Edit 25feb2020: updated medwatch fields for expedited device reporting.No new information added.Edit 06mar2020: added product complaint number to narrative for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a 57-year-old female patient of unknown ethnicity.Medical history included thyroid gland disorders.Concomitant medications included amlodipine besilate / hydrochlorothiazide / olmesartan medoxomil for hypertension, levothyroxine sodium for thyroid gland disorders and other unspecified medication for gastric disorders and gallbladder inflammation.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) via reusable humapen savvio (gray) from 30 to 40 international units (iu) in the morning and 15 to 20 iu each evening, subcutaneously, for diabetes mellitus beginning approximately in 2016.In (b)(6) 2019, she was hospitalized due to a diabetic coma from a low blood glucose level (no values, units or reference ranges provided).After her blood glucose level returned to normal and recovered from the events she was discharged (within the same day).No more details of corrective treatment or laboratory tests done while hospitalized were provided.Additionally, since (b)(6) 2019, she had been experiencing difficulty to inject insulin with her humapen savvio, the injection button sometimes got stuck and was difficult to press (product complaint (b)(4) /lot number 1308v07).She was not sure if she was taking the right dose, and since then, her blood glucose levels were in the range of 400 mg/dl.On unspecified dates, she began to experience gastric disorders, gallbladder inflammation and, she experienced hypertension for a year but it was controlled.The outcome of remaining event was not resolved.Insulin lispro protamine suspension 75%/ insulin lispro 25% therapy status was ongoing.The patient was the operator of the device, but her training status was not provided.The general model duration of use was approximately of four years, but the suspect device model duration of use was unknown.Information regarding improper use of the device, improper storage, device status or action taken was not provided.The suspect humapen savvio (gray) device associated to product complaint (b)(4) was not returned to the manufacturer.The reporting consumer assessed the events as not related to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy, but assessed the events wrong dose, blood glucose increased and diabetic coma as related to the device.Also, she assessed the event gastric disorder to taking a lot of unspecified medications.Edit 25feb2020: updated medwatch fields for expedited device reporting.No new information added.Edit 06mar2020: added product complaint number to narrative for expedited device reporting.No new information added.Update 11mar2020: additional information received on 11mar2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer for the suspect humapen savvio (gray) device associated to product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

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 dated 11mar2020 in the b.5.Field.No further follow-up is planned.Evaluation summary.A female patient reported that the injection button of humapen savvio device sometimes got stuck and she was not sure if she was taking the right dose.She experienced serious events of diabetic coma and decreased blood glucose and a non-serious event of increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1308v07, manufactured august 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 or dose accuracy.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: 9799426
• MDR Text Key: 188252433
• Report Number: 1819470-2020-00020
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9699
• Device Lot Number: 1308V07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR