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

Model Number UNKNOWN

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Coma (2417)

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 spontaneous case, reported by a pharmacist who contacted the company to report adverse events and product complaint, concerned a male patient of an unknown age, and origin.Medical history and concomitant medication were not provided.The patient received human insulin (rdna origin) injections (humulin r 100 units/ml), via a cartridge in a reusable pen (humapen savvio,unknown colour), at an unknown dose, route and frequency for an unknown indication, started on an unknown date.On an unknown date, while on human insulin therapy, his insulin pen was not loading properly (pc (b)(4), lot number unknown).On an unknown date, he had gone to diabetic coma because of not getting his insulin (unspecified reason).The event was considered as serious by the company due to their medical significance.Information regarding the corrective treatment, outcome of the events and the status of human insulin therapy was not provided.The patient was the operator of the humapen savvio device, and his training status was not provided.The general device model duration of use and the suspect device duration of use was not provided.The action taken with the suspect device was not provided and device was available for return.The reporting consumer did not provide the relatedness assessment of the events to the human insulin therapy and humapen savvio device.Edit 09jan2024: updated medwatch and european and canadian (eu/ca) 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 19jan2024 in the b.5.Field.Evaluation summary a pharmacist reported on behalf of a male patient that the patient's humapen savvio was "was not loading properly and that the pen body is faulty." 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 with high probability.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(6) this report is associated with product complaint: (b)(4) this spontaneous case, reported by a pharmacist who contacted the company to report adverse events and product complaint, concerned a male patient of an unknown age, and origin.Medical history and concomitant medication were not provided.The patient received human insulin (rdna origin) injections (humulin r 100 units/ml), via a cartridge in a reusable pen (humapen savvio, unknown colour), at an unknown dose, route and frequency for an unknown indication, started on an unknown date.On an unknown date, while on human insulin therapy, his insulin pen was not loading properly (pc 6877941, lot number unknown).On an unknown date, he had gone to diabetic coma because of not getting his insulin (unspecified reason).The event was considered as serious by the company due to their medical significance.Information regarding the corrective treatment, outcome of the events and the status of human insulin therapy was not provided.Humapen savvio did not return to manufacturer.The patient was the operator of the humapen savvio device, and his training status was not provided.The general device model duration of use and the suspect device duration of use was not provided.The action taken with the suspect device was not provided and device was available for return.The reporting consumer did not provide the relatedness assessment of the events to the human insulin therapy and humapen savvio device.Edit 09jan2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 10-jan-2023: upon internal review of information received on 14-dec-2023, updated device from humapen savvio red to humapen savvio (unknown color) and update pc number.Update 19jan2024: additional information received on 17jan2024 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 device humapen savvio unknown colour associated with (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (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 46285
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis ; 3174332191
• MDR Report Key: 18476250
• MDR Text Key: 332448170
• Report Number: 1819470-2023-00083
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K160668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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: Male