MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN SAVVIO (UNKNOWN COLOR); FOR TREATMENT PURPOSES

Device Problems Excess Flow or Over-Infusion (1311); Mechanical Problem (1384); Misfire (2532)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: pending.This spontaneous case, reported by a pharmacist who contacted the company through a sales representative to report an adverse event and a product complaint (pc), concerned a less than (b)(6) female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog u100/ ml) from cartridge, via a reusable device (humapen savvio).Dose, frequency, route of administration, indication for use and start date were not provided.On an unspecified date, while on insulin lispro, the humapen savvio misfired (as reported) ((b)(4)/ lot number unknown), that caused her a severe hypoglycemia event (values and reference ranges were not provided) which was considered serious for being medically significant.Information regarding corrective treatment, outcome of the event and insulin lispro therapy status was not provided.The operator of the humapen savvio and his/her training status were not provided.The humapen savvio model and reported humapen savvio duration of use were not provided.The action taken with the humapen savvio was not provided.The reporting pharmacist did not provide an assessment of relatedness between the event and insulin lispro therapy but related to the humapen savvio.Edit 01mar2022: updated medwatch 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.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a pharmacist who contacted the company through a sales representative to report an adverse event and a product complaint (pc), concerned a less than 18-year-old female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog u100/ ml) from cartridge, via a reusable device (humapen savvio).Dose, frequency, route of administration, indication for use and start date were not provided.On an unspecified date, while on insulin lispro, the humapen savvio misfired (as reported) ((b)(4) / lot number unknown), that caused her a severe hypoglycemia event (values and reference ranges were not provided) which was considered serious for being medically significant.Information regarding corrective treatment, outcome of the event and insulin lispro therapy status was not provided.The operator of the humapen savvio and his/her training status were not provided.The humapen savvio model and reported humapen savvio duration of use were not provided.The action taken with the humapen savvio was not provided; however, it did not return to manufacturer.The reporting pharmacist did not provide an assessment of relatedness between the event and insulin lispro therapy but related to the humapen savvio.Edit 01mar2022: updated medwatch fields for expedited device reporting.No new information added.Update 22mar2022: additional information received on 17mar2022 from the global product complaint database.Entered the device specific safety summary (dsss); the medwatch and european and canadian (eu/ca) device fields for the suspect humapen savvio device associated with (b)(4), which did not return to manufacturer.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 update statement(s) dated 22mar2022 in the b.5.Field.No further follow-up is planned.Evaluation summary: a pharmacist reported on behalf of a female patient reported that her humapen savvio device "misfired" causing the patient to experience a severe hypoglycemic event.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

• Brand Name: HUMAPEN SAVVIO (UNKNOWN COLOR)
• 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: 13721084
• MDR Text Key: 287275797
• Report Number: 1819470-2022-00021
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female