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

Model Number MS9698

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint concerned a (b)(6) years-old (at the time of initial report) male patient of unknown origin.Medical history included diabetes mellitus diagnosed in 2002.Concomitant medications included human insulin, metformin, insulin detemir and dulaglutide all for an unknown indication.The patient received insulin lispro (rdna origin) (humalog 100u/ml) from cartridge formulation, subcutaneously, through a reusable device humapen savvio (graphite), for treatment of dm2 (type ii diabetes mellitus), beginning approximately in 2016 or 2017 (as reported 4-5 years ago).Dosage regimen was not provided.In (b)(6) 2020, after starting insulin lispro, his diabetes got aggravated, he had problems in eyes due to this, he had blood in eyes and he was hospitalized due to this blood in eye and diabetes aggravated.A surgery was performed and without wearing glasses, his vision was only 30%.The event of vision only 30 percent was considered serious due to its medical significance.On an unknown date, because the cartridge holder of his humapen savvio was loose and when inserting a new cartridge it falls off.The humapen savvio still released insulin but he was afraid of using it because he was unsure if it releases the correct dosage (pc number (b)(4) , lot number 1702v03).Outcome of events blood in eye and diabetes got aggravated were resolved while outcome of remaining event was unknown.Further information regarding corrective treatment and outcome of remaining event unknown.Therapy status of insulin lispro was not provided.The user of the humapen savvio was patient and his training status was not provided.The general humapen savvio model duration of use was unknown and suspect humapen savvio duration of use was approximately 15 months.The action taken with the suspect humapen savvio was not provided and its return was not expected.The reporting consumer did not relate the events blood in eye and diabetes got aggravated with insulin lispro treatment and did not provide relatedness of remaining event with insulin lispro.Reporting consumer did not provide relatedness of events with suspect humapen savvio.Edit 04-feb-2021: upon review of the information received on 21-jan-2021, corrected the partial onset date of event diabetes mellitus aggravation.Edit 04feb2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint concerned a 55-years-old (at the time of initial report) male patient of unknown origin.Medical history included diabetes mellitus diagnosed in 2002.Concomitant medications included human insulin, metformin, insulin detemir and dulaglutide all for an unknown indication.The patient received insulin lispro (rdna origin) (humalog 100u/ml) from cartridge formulation, subcutaneously, through a reusable device humapen savvio (graphite), for treatment of dm2 (type ii diabetes mellitus), beginning approximately in 2016 or 2017 (as reported 4-5 years ago).Dosage regimen was not provided.In (b)(6) 2020, after starting insulin lispro, his diabetes got aggravated, he had problems in eyes due to this, he had blood in eyes and he was hospitalized due to this blood in eye and diabetes aggravated.A surgery was performed and without wearing glasses, his vision was only 30%.The event of vision only 30 percent was considered serious due to its medical significance.On an unknown date, because the cartridge holder of his humapen savvio was loose and when inserting a new cartridge it falls off.The humapen savvio still released insulin but he was afraid of using it because he was unsure if it releases the correct dosage (pc number (b)(4), lot number 1702v03).Outcome of events blood in eye and diabetes got aggravated were resolved while outcome of remaining event was unknown.Further information regarding corrective treatment and outcome of remaining event unknown.Therapy status of insulin lispro was not provided.The user of the humapen savvio was patient and his training status was not provided.The general humapen savvio model duration of use was unknown and suspect humapen savvio duration of use was approximately 15 months.The action taken with the suspect humapen savvio was not provided and was returned to the manufacturer on 08feb2021.The reporting consumer did not relate the events blood in eye and diabetes got aggravated with insulin lispro treatment and did not provide relatedness of remaining event with insulin lispro.Reporting consumer did not provide relatedness of events with suspect humapen savvio.Edit 04-feb-2021: upon review of the information received on 21-jan-2021, corrected the partial onset date of event diabetes mellitus aggravation.Edit 04feb2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 21mar2021: additional information received on 15mar2021 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields, improper use and storage from no to yes, malfunction from unknown to yes, and device return status to returned to manufacturer.Added the date of manufacture and date returned to manufacturer for the suspect device associated with pc (b)(4).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 statement dated 21mar2021 in the b.5.Field.No further follow up is planned.Evaluation summary: a male patient reported the cartridge holder of his humapen savvio device was loose, and when inserting a new cartridge, it falls off.He was unsure if the device released the correct dosage.The patient experienced diabetes mellitus inadequate control.Initial assessment of the returned device associated with this complaint found the cartridge holder remained attached and the device functioned normally.Additional investigation of the returned device (batch 1702v03, manufactured february 2017) by the manufacturing site found the cartridge holder did not attach securely to the device, and found the housing collar was damaged due to foreign material (waxy residue) on the housing collar.The damage in the housing collar is consistent with exposure to foreign material containing fatty acids.Malfunction confirmed.Both the housing collar damage and the foreign material contamination occurred in the field (not a manufacturing related issue).The core instructions for use provides adequate care and storage directions.It states, "do not use alcohol, hydrogen peroxide or bleach on the pen body or dose window.Also, do not cover in liquid or apply lubrication such as oil, as this could damage the pen." the patient reported visual impairment.The core instructions for use states that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The damage to the device due to foreign material contamination occurred while in the field (not related to the manufacturing process).This misuse may be relevant to the event of diabetes mellitus inadequate control.The patient used the device while visually impaired.It is unknown if this misuse is relevant to the event of diabetes mellitus inadequate control.

• 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
• MDR Report Key: 11278772
• MDR Text Key: 233752623
• Report Number: 1819470-2021-00023
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 1702V03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 55 YR