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

Model Number MS9698

Device Problem Break (1069)

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a female patient reported that the injection screw of her humapen savvio device was broken.She experienced decreased blood glucose and coma.The device was not returned to the manufacturer for investigation (batch 1212v07, manufactured december 2012).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 injection screw broken or dose accuracy issues.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.

Event Description

Lilly case id: (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) (at the time of initial report) female patient of unknown ethnicity.Medical history included gastrointestinal disorder (git).Concomitant medication included unspecified medications for gastrointestinal disorder.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humalog 75/25) cartridge, via a reusable pen (humapen savvio graphite), at 35 international units before breakfast and 25 international units before dinner, twice daily, subcutaneously, for diabetes mellitus, beginning approximately sometime in 2004 (reported as 10-15 years ago).On unknown dates while on human insulin 70/30 treatment, she had repeated coma about four times and the most recent one was on approximately (b)(6) 2019 and had low blood glucose levels (values, units and normal reference range not provided).The events of blood glucose decreased and coma were considered as serious due to medically significant reason.She preferred using the humapen savvio graphite device than syringe as syringe was more painful for her.On (b)(6) 2019, her blood glucose value was 130 mg/dl (normal reference range not provided).She was hypertensive and was taking unspecified medication for treatment.She mentioned that the humapen savvio graphite screw was broken and the humapen savvio graphite was not working /black part was not working properly for two months (pc number: (b)(4) and lot number: 1212v07).Information regarding the additional corrective treatment was not provided.As of (b)(6) 2019, her glucose level was normal, she got recovered with sequellae from the repeated coma and the other outcomes for remaining events were not reported.Human insulin 70/30 treatment was continued.The patient was the operator of the device and her training status was not provided.The general model humapen savvio graphite duration was approximately 15 years (started approximately in 2004) and the suspect device duration of use associated with (b)(4) was not provided.The suspect device, which was manufactured in dec2012, was not returned to the manufacturer.The reporting consumer did not relate the event of repeated coma while did not provide relatedness for the remaining events with human insulin 70/30 treatment.The reporting consumer related the event of repeated coma while did not provide relatedness for the remaining events with its humapen savvio graphite device.Edit 21-nov-2019: upon review of information received on (b)(6) 2019, as determined causality for both listed serious events was changed to yes.No other changes were done.Edit 09dec2019: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 10dec2019: additional information received on 10dec2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information, improper use and storage from yes to no, and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 1212v07 of humapen savvio (graphite) device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAPHITE)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 9450799
• MDR Text Key: 187244050
• Report Number: 1819470-2019-00214
• 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
• Report Date: 12/11/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9698
• Device Lot Number: 1212V07
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR