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

Model Number MS9698

Device Problem Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Confusion/ Disorientation (2553)

Event Date 02/06/2020

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 case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old female patient of an unknown origin.Medical history included hypertension.Concomitant medications included unspecified medications for hypertension.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from an unknown formulation via a reusable device humapen savvio (graphite), 50 iu in the morning and 20 iu at night two times a day subcutaneously for the treatment of diabetes mellitus beginning approximately in 2015.He started humapen savvio (graphite) approximately in 2018.On (b)(6) 2020 while on human insulin isophane suspension 70%/human insulin 30% treatment, the screw of the injection pen was stuck and could not release insulin dose (pc#: unknown; lot#: 1310v01) and due to the humapen savvio issue she missed to inject the dose of human insulin isophane suspension 70%/human insulin 30% for five days.On (b)(6) 2020, she had hyperglycemia associated with hallucination and confusion therefore ambulance was called and transferred to the hospital where she stayed for four hours until her blood glucose level was adjusted, however treating physician believed she could have been comatose unless she was transferred to the hospital.Further her blood sugar was elevated due to missed dose.The events hyperglycemia, hallucination and confusion were considered as serious due to medical significance reasons.Since (b)(6) 2020 she started taking human insulin isophane suspension 70%/human insulin 30% doses using the insulin syringe.On (b)(6) 2020 her blood glucose level was return to normal.Information regarding corrective treatment was not provided.Outcome of the events was resolved.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The operator of the humapen savvio (graphite) was unknown and his/her training status was not provided.The general model humapen savvio (graphite) duration of use was not provided and the suspect humapen savvio (graphite) duration of use was approximately two years as it was started approximately in 2018.The humapen savvio (graphite) was discontinued in (b)(6) 2020 and its return status was expected.The reporting consumer did not relate the events to human insulin isophane suspension 70%/human insulin 30% drug.The reporting consumer related the events to the humapen savvio (graphite) device issue.Edit 18feb2020: updated medwatch and european and (b)(6) (eu/(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(s) dated 04mar2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that the injection screw of her humapen savvio device was stuck and could not release insulin.She missed the insulin doses for five days.She experienced hyperglycemia.The device was not returned to the manufacturer for investigation (batch 1310v01, manufactured october 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with respect to device not working.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.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 66-year-old female patient of an unknown origin.Medical history included hypertension.Concomitant medications included unspecified medications for hypertension.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from cartridge formulation via a reusable device humapen savvio (graphite), 50 iu in the morning and 20 iu at night two times a day subcutaneously for the treatment of diabetes mellitus beginning approximately in 2015.He started humapen savvio (graphite) approximately in 2018.On (b)(6) 2020 while on human insulin isophane suspension 70%/human insulin 30% treatment, the screw of the injection pen was stuck and could not release insulin dose (pc: (b)(4); lot: 1310v01) and due to the humapen savvio issue she missed to inject the dose of human insulin isophane suspension 70%/human insulin 30% for five days.On (b)(6) 2020, she had hyperglycemia associated with hallucination and confusion therefore ambulance was called and transferred to the hospital where she stayed for four hours until her blood glucose level was adjusted, however treating physician believed she could have been comatose unless she was transferred to the hospital.Further her blood sugar was elevated due to missed dose.The events hyperglycemia, hallucination and confusion were considered as serious due to medical significance reasons.Since (b)(6) 2020 she started taking human insulin isophane suspension 70%/human insulin 30% doses using the insulin syringe.On (b)(6) 2020 her blood glucose level was return to normal.Information regarding corrective treatment was not provided.Outcome of the events was resolved.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The operator of the humapen savvio (graphite) was unknown and his/her training status was not provided.The general model humapen savvio (graphite) duration of use was not provided and the suspect humapen savvio (graphite) duration of use was approximately two years as it was started approximately in 2018.The humapen savvio (graphite), which was manufactured in oc t2013, was discontinued in 06-feb-2020 and not returned to the manufacturer.The reporting consumer did not relate the events to human insulin isophane suspension 70%/human insulin 30% drug.The reporting consumer related the events to the humapen savvio (graphite) device issue.Edit 18feb2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 19-feb-2020: on review updated product complaint (pc) number ((b)(4)) in narrative.Update 04mar2020: additional information received on 03mar2020 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.Added date of manufacturer for pc (b)(4)associated with 1310v01 lot of a humapen savvio (graphite) device.Updated formulation from unknown to cartridge formulation.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAPHITE)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis, in
• MDR Report Key: 9728965
• MDR Text Key: 185911621
• Report Number: 1819470-2020-00019
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9698
• Device Lot Number: 1310V01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR