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

Model Number MS9699

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Inflammation (1932); Numbness (2415); Coma (2417)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

Description of problem or event: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 07aug2019.No further follow-up is planned.Evaluation summary: a male patient reported the injection screw of his humapen savvio device was not working properly and as a consequence the device dispensed an extra dose of insulin.He experienced hypoglycemic coma during 2018.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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.The patient reported he did not miss any doses as he was using the humapen ergo of his sister.The core user manual states, "do not share your pen or needles as this may risk transmission of infectious agents" and "always carry a spare insulin pen in case your pen is lost or damaged." there is evidence of improper use.The patient used another individual's pen.This is not likely relevant to the event of hypoglycemic coma.

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)-year-old male patient of an unspecified origin.Medical history included a previous use of a humapen savvio on unspecified dates.Concomitant medications included pregabalin, benfotiamine/ cyanocobalamin/ pyridoxine hydrochloride and hydroxocobalamin; all for the treatment of neuropathy.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) suspension via a reusable pen (humapen savvio gray), 30 iu before taking breakfast or lunch, subcutaneously for the treatment of diabetes beginning approximately before 2009.Approximately, since 2015, he was experiencing numbness in his toes, so was prescribed with pregabalin firstly once daily, and then his dose was increased to twice daily.Approximately, since 2016 he was experiencing inflammation in his palm joints.On an unspecified date, but during 2018 reportedly he was hungry, but did not eat anything and took his insulin dose which lead to a low blood glucose associated with coma (no units or values were provided).The patient took a juice and recovered.This event of blood glucose associated with coma was considered as serious by the company due to its medical significance.On an unspecified date, approximately since (b)(6) 2019 he was experiencing high blood glucose levels sometimes reaching 270-280 mg/dl (reference values were not provided).On (b)(6) 2019, it was reported that on an unspecified date the screw of the humapen savvio was not working properly and as a consequence the humapen savvio dispensed an extra dose of insulin (pc: (b)(4)/lot: unknown).The humapen savvio possibly had been used for more than 3 years.Reportedly, he did not miss any doses as he was using the humapen ergo of his sister; he did not have his own spare pen.Information regarding additional corrective treatment was not provided.The outcome of the events of numbness, joint inflammation, and high blood glucose levels was not recovered.He recovered from the event of low blood glucose associated with coma.The outcome of the remaining events was not provided.The treatment with human insulin 70/30 was ongoing.The user of the humapen savvio was the patient but his training status was not provided.The general model duration of use was not provided, but the humapen savvio model had been used for more than 4 years.The duration of use for the humapen savvio considered as suspect was not provided, but at the time of initial report it had been used likely for about 3 or 4 years.The suspect device was not returned to the manufacturer.The reporting consumer considered the event of low blood glucose associated with coma as related to the treatment with human insulin 70/30 and did not provide any other opinion of causality between remaining events and human insulin 70/30 treatment.The reporting consumer considered the event of extra dose of insulin as related to the humapen savvio, did not provide an opinion of causality between event of hunger and the humapen savvio and considered the remaining events as not related to the humapen savvio.Edit 01aug2019: upon review, the reported date for (b)(4) associated with the humapen savvio gray device was added to the case.No other changes were made.Update 07aug2019: additional information received on (b)(4) 2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(4) (eu/(b)(4)) device information, and device return status to not returned to manufacturer for (b)(4) associated to unknown lot of humapen savvio (gray) device.Upon internal review, changed the device age to 4 years.Corresponding fields and narrative updated accordingly.

• 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
• 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: 8879473
• MDR Text Key: 154107903
• Report Number: 1819470-2019-00143
• 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: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9699
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 53 YR