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

Model Number MS9699

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case reported by a consumer via a patient support program (psp), concerned a 68-year-old female patient of an unknown origin.Medical history included diabetes mellitus for 30 years.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) cartridge via a reusable pen (humapen savvio gray) at an unknown dose, route and frequency for the treatment of diabetes mellitus beginning on an unknown date in 2007.On an unknown date, after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, she experienced that her vison had weakness, so she preferred pen over syringe.She had savvio pen that was not working (batch 1311v05, pc 6186319 when pressing on pen to administer the dose, the pen got broken into parts she used another pen to administer the dose (from other unspecified manufacture), another pen got broken too, she used the same pen and the same insulin type with her husband, she starting to withdraw the insulin from cartridge.As of information received on 29-oct-2022, she was going to perform amputation of two fingers due to diabetes.The event of diabetes mellitus was considered as serious by the company due to medically significant reason.Information about corrective treatment was unknown.Outcome of the event wrong patient received product was unknown.Outcome of the remaining events were not recovered.Status of insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The operator of the humapen savvio gray device was patient husband and his training status were unknown.The general model humapen savvio gray device duration and the suspect humapen savvio gray device duration were unknown.The suspect device status was unknown and its return was expected.The reporting consumer related the event withdrawing insulin from cartridge by syringe to the insulin lispro protamine suspension 75%/insulin lispro 25% therapy and the savvio device.The reporting consumer did not know the relatedness of the remaining events to the the insulin lispro protamine suspension 75%/insulin lispro 25% therapy and the savvio gray device.Update 03-nov-2022: this case was initially determined to be non-serious.Additional information received from the initial reporter on 29-oct-2022 via psp upgraded the case to serious.Added serious event diabetes mellitus and suspect device humapen savvio gray.Updated causality statement and narrative with new information.Edit 14nov2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

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.

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 21dec2022 in the b.5.Field.No further follow-up is planned.Evaluation summary the patient's husband reported that her hp savvio device was not working.When the reporter was pressing on pen to administer the dose, the pen broke into parts.Patient uses the same pen and the same insulin type with her husband.Patient starting to withdraw the insulin from cartridge, but the reporter stated that she couldn't use syringe due to vision weakness.Patient experienced diabetes mellitus(dm).Device not returned to the manufacturer for investigation (batch 1311v05, manufactured nov2013).Hence, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.Total number of complaints received for batch 1311v05 is within the established batch threshold and the batch is not atypical.All hp savvio devices are assessed for injection screw travel at the end of the manufacturing process, ensuring device functionality with high probability.Likely patient used the device beyond its approved use life.Core instructions stated hp ergo ii has been designed to be used for up to 3 years after first use.The reporter and the patient had vision issues, including that the patient could not see the calibration of the injection pen clearly.The core instructions for use state that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.The user reported that he and the patient used the same insulin pen.The core instructions stated,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.The user reported that the patient withdrew the insulin from the cartridge with a syringe.There is evidence of improper use.The user and patient used the device while visually impaired, likely used the device beyond its approved use life, shared the same injection pen with another individual, and withdrew the insulin with a syringe.It is unknown if these misuses are relevant to the event of dm.

Event Description

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This solicited case reported by a consumer via a patient support program (psp), concerned a 68-year-old female patient of an unknown origin.Medical history included diabetes mellitus for 30 years.Concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) cartridge via a reusable pen (humapen savvio gray) at an unknown dose, route and frequency for the treatment of diabetes mellitus beginning on an unknown date in 2007.On an unknown date, after starting insulin lispro protamine suspension 75%/insulin lispro 25% therapy, she experienced that her vison had weakness, so she preferred pen over syringe.She had savvio pen that was not working (batch 1311v05, pc (b)(4) when pressing on pen to administer the dose, the pen got broken into parts she used another pen to administer the dose (from other unspecified manufacture), another pen got broken too, she used the same pen and the same insulin type with her husband, she starting to withdraw the insulin from cartridge.As of information received on 29-oct-2022, she was going to perform amputation of two fingers due to diabetes.The event of diabetes mellitus was considered as serious by the company due to medically significant reason.Information about corrective treatment was unknown.Outcome of the event wrong patient received product was unknown.Outcome of the remaining events were not recovered.There was evidence of improper use of device as the device was used beyond its approved use life, shared the same injection pen with another individual, and withdrew the insulin with a syringe.Status of insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The operator of the humapen savvio gray device was patient husband and his training status were unknown.The general model humapen savvio gray device duration and the suspect humapen savvio gray device duration were unknown.The suspect device status was unknown and device was not returned to manufacturer.The reporting consumer related the event withdrawing insulin from cartridge by syringe to the insulin lispro protamine suspension 75%/insulin lispro 25% therapy and the savvio device.The reporting consumer did not know the relatedness of the remaining events to the the insulin lispro protamine suspension 75%/insulin lispro 25% therapy and the savvio gray device.Update 03-nov-2022: this case was initially determined to be non-serious.Additional information received from the initial reporter on 29-oct-2022 via psp upgraded the case to serious.Added serious event diabetes mellitus and suspect device humapen savvio gray.Updated causality statement and narrative with new information.Edit 14nov2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 21dec2022: additional information received on 20dec2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for pc (b)(4) associated with lot number 1311v05 of humapen savvio (gray).Updated improper use and storage from no to yes, date of manufacturer, device return status to not returned to manufacturer.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): 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: 15855537
• MDR Text Key: 304220308
• Report Number: 1819470-2022-00086
• 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: 01/03/2023

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: Other
• Device Model Number: MS9699
• Device Lot Number: 1311V05
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2013
• 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: 68 YR
• Patient Sex: Female