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

Model Number MS9699

Device Problem Material Separation (1562)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Date 10/03/2019

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 compliant: pending.This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unknown origin.Medical history included diabetes mellitus, undergone a vertebral column surgery, for vertebrae number 4 and 5.Concomitant medications included glimepiride and metformin hydrochloride for diabetes mellitus, captopril/hydrochlorothiazide for hypertension, benfotiamine/cyanocobalamin/pyridoxine hydrochloride for neuro-strengthening, unspecified vitamins for bone strengthening and unspecified analgesics for bone ache.The patient received insulin lispro (rdna origin) (humalog, 100 u/ml) via a prefilled kwikpen, 60 u morning and 40 u at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date approximately in 2014 (five years ago).Approximately in 2017 (1.5 to 2 years ago) the treating physician advised to replace kwikpen by humapen savvio (gray).Since an unknown date in 2019 (few months ago), he was diagnosed with a cartilage slip in one of the neck vertebrae, which lead to symptoms as arm numbness, loss of sensation, and body tingles.He was scheduled to undergo a neck surgery after an orthopedic consult.The event of cartilage slip in neck vertebrae and loss of sensation were considered as serious by company due to their medically significance.Approximately on (b)(6) 2019, the humapen savvio (gray) injection button had been separated from the pen, leading to inability to use the pen and he had missed all of the week doses (pc# unknown, lot# 1311v55), and the blood glucose level went to a high level, around 650 mg/dl.The event of blood glucose increased was considered as serious by company due to its medically significance.Information regarding corrective treatment was not provided.Outcome of the events was not recovered.Status of insulin lispro therapy was ongoing.The operator of the reusable humapen savvio (gray) device and his/her training status was not provided.The general reusable humapen savvio (gray) device model duration of use and suspect reusable device duration of use was approximately two years (started in 2017).The action taken with status of suspect reusable humapen savvio (gray) device was unknown.The status of suspect reusable humapen savvio (gray) device was ongoing and the return of suspect reusable humapen savvio (gray) device was expected.The initial reporting consumer did not consider the events of missed dose and blood glucose increased related to insulin lispro drug but considered them related to humapen savvio (gray) device.The initial reporting consumer did not consider the reaming events related to insulin lispro drug and humapen savvio (gray) device.Edit 17-oct-2019: upon review of the initial information, changed one mention of the device in narrative from humapen ergo ii to humapen savvio (gray).No new information was added to the case.Edit 22oct2019: updated medwatch fields for expedited device reporting.No new information added.

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 41-year-old male patient of unknown origin.Medical history included diabetes mellitus, undergone a vertebral column surgery, for vertebrae number 4 and 5.Concomitant medications included glimepiride and metformin hydrochloride for diabetes mellitus, captopril/hydrochlorothiazide for hypertension, benfotiamine/cyanocobalamin/pyridoxine hydrochloride for neuro-strengthening, unspecified vitamins for bone strengthening and unspecified analgesics for bone ache.The patient received insulin lispro (rdna origin) (humalog, 100 u/ml) via a prefilled kwikpen, 60 u morning and 40 u at night, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date approximately in 2014 (five years ago).Approximately in in 2017 (1.5 to 2 years ago) the treating physician advised to replace kwikpen by humapen savvio (gray).Since an unknown date in 2019 (few months ago), he was diagnosed with a cartilage slip in one of the neck vertebrae, which lead to symptoms as arm numbness, loss of sensation, and body tingles.He was scheduled to undergo a neck surgery after an orthopedic consult.The event of cartilage slip in neck vertebrae and loss of sensation were considered as serious by company due to their medically significance.Approximately on (b)(6) 2019, the humapen savvio (gray) injection button had been separated from the pen, leading to inability to use the pen and he had missed all of the week doses and the blood glucose level went to a high level, around 650 mg/dl (pc (b)(4)/lot number 1311v05 reported as 1311v55).The event of blood glucose increased was considered as serious by company due to its medically significance.Information regarding corrective treatment was not provided.Outcome of the events was not recovered.Status of insulin lispro therapy was ongoing.The operator of the reusable humapen savvio (gray) device and his/her training status was not provided.The general reusable humapen savvio (gray) device model duration of use and suspect reusable device duration of use was approximately two years (started in 2017).The suspect device was not returned to the manufacturer.The initial reporting consumer did not consider the events of missed dose and blood glucose increased related to insulin lispro drug but considered them related to humapen savvio (gray) device.The initial reporting consumer did not consider the reaming events related to insulin lispro drug and humapen savvio (gray) device.Edit 17-oct-2019: upon review of the initial information, changed one mention of the device in narrative from humapen ergo ii to humapen savvio (gray).No new information was added to the case.Edit 22oct2019: updated medwatch fields for expedited device reporting.No new information added.Update 06nov2019: additional information received on 06nov2019 from global product complaint database.Changed the lot number from 1311v55 to 1311v05 for product complaint (b)(4)relating to the humapen savvio (gray).Corresponding fields and narrative updated accordingly.Update 12nov2019: additional information received on 12nov2019 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 for pc (b)(4)associated with lot 1311v05 (reported as 1311v55) of humapen savvio (gray) device.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(s) dated 12nov2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported the injection button of his humapen savvio device had been separated from the pen, leading to the inability to use the pen and missing all of the week's doses.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch reported as 1311v55, which is not a valid batch number).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A review of similar batch numbers identified batch 1311v05 as the likely batch involved in this complaint.A complaint history review of the batch did not identify any atypical findings with respect to known injection button detachment related manufacturing issues, for which manufacturing controls had already been implemented.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The core instructions for use state to always carry a spare insulin pen in case your pen is lost or damaged.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: 9261309
• MDR Text Key: 184499758
• Report Number: 1819470-2019-00193
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• 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: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR