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

Model Number MS9699

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

New updated and corrected information is referenced within the update statements in describe event or problem.No further follow up is planned.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a 49 years old male patient of unknown ethnicity.Medical history included vision reduced.Concomitant medications were not provided.The patient received insulin lispro (rdna origin) injection (humalog) cartridge, 10 iu daily, and also insulin glargine injection (basaglar) cartridge, 18 iu daily, both via unknown route of administration, for unknown indication, beginning on an unknown date.On an unspecified date, unknown time after beginning insulin lispro and insulin glargine via humapen savvio gray (lot 1411v01), the injection button was not doing the click sound and the injection screw was not going further ((b)(4) / lot number 1411v01).Due to this, the patients glycemia did not decrease and got higher, up to almost 500, considered serious by the company due to medical significance.The patient was reported to have trouble injecting due to his reduced vision and it was informed that a patient with vision impairment should have help from a trained user for injection.Additional information regarding corrective treatments and outcomes was not provided.It was unknown if insulin lispro and insulin glargine therapies were continued.The device was operated by the patient, however it was unknown if he received training and how long the operator had used the device model.The reported device was in use for over three years.The suspect device was not returned to the manufacturer.The reporting consumer considered the event related to insulin lispro, insulin glargine and to the device.Update 07mar2018: additional information received on 05mar2018 from the initial reporting consumer.No new information was provided.Update 12mar2018: additional information received on 08mar2018 from the initial reporting consumer via psp.Added patient email and phone number.Added vision reduced as medical history.Changed humapen unknown device to humapen savvio.Added humapen savvio lot.Changed humapen savvio improper use from no to yes and operator from unknown to lay user/patient.Changed blood glucose increased to serious event.Updated narrative and corresponding fields accordingly.Edit 15mar2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 16mar2018: upgraded case priority and updated european and canadian (eu/ca) fields.Update 19mar2018: additional information received on 19mar2018 from the initial reporting consumer.Changed humapen savvio preliminary comments to usage concerns resolved, and device was reported to be working properly.Added humapen savvio device age.Added basaglar dosing regimen.Updated narrative and corresponding fields accordingly.Update 22mar2018: additional information received on 21mar2018 from the global product complaint database.Entered device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; added date of manufacturer for the suspect humapen savvio (gray) device associated with pc 4293820.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): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 7399214
• MDR Text Key: 104469057
• Report Number: 1819470-2018-00040
• 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: 04/05/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9699
• Device Lot Number: 1411V01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2014
• 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: 49 YR