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 Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.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 consumer who contacted company to report an adverse event and a product complaint, concerned a male patient of an unknown age and origin.Medical history was not reported.Concomitant medications included rapid basal insulin via optipen administered for unspecified indication.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) from a cartridge via a reusable pen humapen unknown device, administered subcutaneously.Information regarding dose, dosage frequency, route of administration, indication, and therapy start date was not provided.It was reported that his humapen unknown device was defective and did not work properly(pc number: (b)(4) and lot number: unknown), due to which on an unknown date, he experienced hypoglycemia and was hospitalized.As of (b)(6) 2023 he was discharged from hospital.Information regarding further hospitalization details and the corrective treatment received were not provided.The outcome of event hypoglycemia was resolved.The status of insulin lispro therapy was not provided.Follow-up was not possible as reporter refused contact.The operator of humapen unknown device and his/her training status was not provided.The general humapen model duration of use and the suspect humapen duration of use was unknown.It was unknown if the suspect humapen unknown device was available for return.The initial reporting consumer did not provide the relatedness of the event with insulin lispro and considered the event related with humapen unknown device.Edit 13jun2023: updated medwatch 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 (b)(6) 2023 in the b.5.Field.No further follow-up is planned.Evaluation summary a male patient reported that his humapen savvio device was defective and did not work properly.The patient experienced hypoglycemia.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.

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 company to report an adverse event and a product complaint, concerned a male patient of an unknown age and origin.Medical history was not reported.Concomitant medications included rapid basal insulin via optipen administered for unspecified indication.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) from a cartridge via a reusable pen humapen savvio gray, administered subcutaneously.Information regarding dose, dosage frequency, route of administration, indication, and therapy start date was not provided.It was reported that his humapen savvio gray was defective and did not work properly (pc number: (b)(4) and lot number: unknown), due to which on an unknown date, he experienced hypoglycemia and was hospitalized.As of (b)(6) 2023 he was discharged from hospital.Information regarding further hospitalization details and the corrective treatment received were not provided.The outcome of event hypoglycemia was resolved.The status of insulin lispro therapy was not provided.Follow-up was not possible as reporter refused contact.The operator of humapen savvio gray and his/her training status was not provided.The general humapen model duration of use and the suspect humapen duration of use was unknown.Humapen savvio gray did not return to manufacturer.The initial reporting consumer did not provide the relatedness of the event with insulin lispro and considered the event related with humapen savvio gray.Edit 13jun2023: updated medwatch fields for expedited device reporting.No new information added.Update 27jun2023: additional information received on 21jun2023 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields for the suspect humapen savvio gray device associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 28jun2023: upon internal review updated device model from humapen unknown device to humapen savvio gray.

• 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: catherine cassidy ; lilly corporate center; indianapolis, IN 46285 ; 3174332191
• MDR Report Key: 17192993
• MDR Text Key: 317817481
• Report Number: 1819470-2023-00046
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9699
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2023
• 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): Hospitalization
• Patient Sex: Male