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

Model Number MS9699

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems Hypoglycemia (1912); Coma (2417)

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 solicited retrospective maternal case, reported by a consumer via patient support program (psp), concerned a (b)(6) female patient of unknown origin.Medical and obstetrical history included pregnancy and diabetic (since 2006).Further maternal high-risk behaviors were none.Concomitant medications were not provided.The patient received human insulin isophane suspension (rdna origin) injections (humulin n) from cartridge, via a reusable pen (humapen savvio gray), at unknown dose, unknown dosing frequency, via unknown route of administration, for treatment of diabetes, beginning on an unknown date.On an unknown date approximately in 2016, she started to use humapen savvio gray.The date of her last menstrual period and estimate due date (edd) were not provided.No prenatal tests were reported.She received human insulin isophane suspension at conception and during the first trimester of the pregnancy.On an unknown date, while on human insulin isophane suspension, it was not suitable for her during pregnancy as she was suffering from hypoglycemic coma.On an unknown date approximately in 2019, she discontinued human insulin isophane suspension therapy.On an unknown date, she was shifted to another type of insulin.Approximately on (b)(6) 2020, she delivered a full term infant (gender was not provided).Information regarding weight, length and apgar scores was not provided.No complications for the fetus were reported.She always take care of her blood glucose level, also his hba1c always within 5-5.5 mg/dl even while she was pregnant.On an unknown date, humapen got impaired as the injection button became heavy upon pressing and upon releasing the dose not like it was at first (pc: (b)(4); lot number: 1308v07).The event of hypoglycemic coma was considered as serious by the company due to medical significant reason.Information regarding corrective treatment and outcome of events was not provided.On an unknown date in 2019, human insulin isophane suspension therapy was discontinued.Patient was the operator of humapen savvio gray and her training status was not provided.The general model humapen savvio gray duration of use was not provided and the suspect humapen savvio gray duration of use was approximately three years as it was started approximately in 2016.Suspect humapen savvio gray was continued and its return was not expected.The reporting consumer did not provide relatedness assessment of the events with human insulin isophane suspension drug and suspect humapen savvio gray device.Update 28-dec-2021: all the information received on 25-dec-2021 were processed together.Update 03-jan-2022: information was received from the affiliate, regarding follow-up attempt on 29-dec-2021, via psp.The reporter was called but was not connected.No follow-up information was obtained and no changes were made to the case.Update 11-jan-2022: information received from responsible complaint personnel (rcp) on 07-jan-2022 only included product complaint (pc) number which was processed accordingly.No other medically significant changes were made to the case.Edit 12-jan-2022: updated medwatch and (b)(6) fields for expedited device reporting.No new information added.

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 31jan2022 in the b.5.Field.No further follow-up is planned evaluation summary a female patient reported that her humapen savvio device "got impaired as the injection button became heavy upon pressing and upon releasing the dose not like it was at first." she experienced hypoglycemic coma.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 batch complaint threshold review did not identify any atypical findings with regard to the dose accuracy issues.The total number of complaints received for batch 1308v07 is within the established batch threshold and the batch is not atypical.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality 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 complaint: (b)(4).This solicited retrospective maternal case, reported by a consumer via patient support program (psp), concerned a 32-years-old female patient of unknown origin.Medical and obstetrical history included pregnancy and diabetic (since 2006).Further maternal high-risk behaviors were none.Concomitant medications were not provided.The patient received human insulin isophane suspension (rdna origin) injections (humulin n) from cartridge, via a reusable pen (humapen savvio gray), at unknown dose, unknown dosing frequency, via unknown route of administration, for treatment of diabetes, beginning on an unknown date.On an unknown date approximately in 2016, she started to use humapen savvio gray.The date of her last menstrual period and estimate due date (edd) were not provided.No prenatal tests were reported.She received human insulin isophane suspension at conception and during the first trimester of the pregnancy.On an unknown date, while on human insulin isophane suspension, it was not suitable for her during pregnancy as she was suffering from hypoglycemic coma.On an unknown date approximately in 2019, she discontinued human insulin isophane suspension therapy.On an unknown date, she was shifted to another type of insulin.Approximately on (b)(6) 2020, she delivered a full term infant (gender was not provided).Information regarding weight, length and apgar scores was not provided.No complications for the fetus were reported.She always take care of her blood glucose level, also his hba1c always within 5-5.5 mg/dl even while she was pregnant.On an unknown date, humapen got impaired as the injection button became heavy upon pressing and upon releasing the dose not like it was at first (pc: 5840198; lot number: 1308v07).The event of hypoglycemic coma was considered as serious by the company due to medical significant reason.Information regarding corrective treatment and outcome of events was not provided.On an unknown date in 2019, human insulin isophane suspension therapy was discontinued.Patient was the operator of humapen savvio gray and her training status was not provided.The general model humapen savvio gray duration of use was not provided and the suspect humapen savvio gray duration of use was approximately three years as it was started approximately in 2016.Suspect humapen savvio gray was continued and its return was not expected.The reporting consumer did not provide relatedness assessment of the events with human insulin isophane suspension drug and suspect humapen savvio gray device.Update 28-dec-2021: all the information received on 25-dec-2021 were processed together.Update 03-jan-2022: information was received from the affiliate, regarding follow-up attempt on 29-dec-2021, via psp.The reporter was called but was not connected.No follow-up information was obtained and no changes were made to the case.Update 11-jan-2022: information received from responsible complaint personnel (rcp) on 07-jan-2022 only included product complaint (pc) number which was processed accordingly.No other medically significant changes were made to the case.Edit 12jan2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 14-jan-2022: information received on 11-jan-2021 from a physician in response of a medical questionnaire did not include new medical significant information as health care professional (hcp) was not aware of the case.No changes were made to the case.Update 17-jan-2022: information received from responsible complaint personnel (rcp) on 11-jan-2022 only included pc number which was already processed in the case.No other medically significant changes were made to the case.Update 31jan2022: additional information received on 27jan2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for the suspect humapen savvio (gray) (lot number: 1308v07) device associated with product complaint 5840198.The device return status was updated as not returned to manufacturer and added date of manufacture for the device.Corresponding fields and narrative updated accordingly.Edit 02feb2022: the case was unlocked to perform minor edits (uncheck product problems) in medwatch fields.

• 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): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 13260455
• MDR Text Key: 289057474
• Report Number: 1819470-2021-00186
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• 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: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2013
• 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: 32 YR
• Patient Sex: Female