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

Model Number MS9699

Device Problems Device Inoperable (1663); Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Underdose (2542)

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

(b)(4).This spontaneous case, reported by a consumer, who contacted the company to report a product complaint and adverse events, concerns a (b)(6) female patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (humalog) cartridge, unknown dose, route, frequency, indication and start date.Since unknown date, unspecified time after beginning treatment with insulin lispro via humapen savvio gray (lot unknown), insulin lispro was not getting out of device, which was not working ((b)(4)), hence insulin lispro had not been injected and, for this reason, patient s glucose was very high.On (b)(6) 2017, blood glucose increased led patient to hospitalization during one week.On (b)(6) 2017, patient was discharged.Information regarding laboratorial exams, corrective treatment and outcome was not provided.As of 15aug2017, insulin lispro had been delivered via syringe.Treatment with insulin lispro was ongoing.It was unknown who operated the device and if the operator was trained.The device model and the reported device had been used for unspecified time.Device return status was unknown and it was discontinued.The reporting consumer did not provide any relatedness opinion between the events and insulin lispro.Update 08sep2017: updated medwatch fields for expedited device reporting.No new information added.

Manufacturer Narrative

New updated and corrected information is referenced within the update statements.Please refer to statement dated 18sep2017.  no further follow up is planned.Evaluation summary: the mother of a female patient reported that her daughter's humapen savvio device was not delivering the insulin.The patient experienced abnormal blood glucose.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 spontaneous case, reported by a consumer, who contacted the company to report a product complaint and adverse events, concerns a (b)(4) female patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (humalog) cartridge, unknown dose, route, frequency, indication and start date.Since unknown date, unspecified time after beginning treatment with insulin lispro via humapen savvio gray, insulin lispro was not getting out of device, which was not working (product complaint (b)(4)/lot unknown), hence insulin lispro had not been injected and, for this reason, the glucose of the patient was very high; actual value was not provided.On (b)(6) 2017, blood glucose increased led patient to hospitalization during one week.On (b)(6) 2017, patient was discharged.Information regarding laboratorial exams, corrective treatment and outcome was not provided.As of (b)(6) 2017, insulin lispro had been delivered via syringe.Treatment with insulin lispro was ongoing.It was unknown who operated the device and if the operator was trained.The device model and the reported device had been used for unspecified time.The suspect device was not returned to the manufacturer and was discontinued.The reporting consumer did not provide any relatedness opinion between the events and insulin lispro; device relatedness not provided.Update 08sep2017: updated medwatch fields for expedited device reporting.No new information added.Update 18sep2017: additional information received on 15sep2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and (b)(6) (eu/(b)(6)) device information and device return status to not returned to manufacturer for the pc (b)(4) associated with the humapen savvio (gray) device.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: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6863260
• MDR Text Key: 86081978
• Report Number: 1819470-2017-00162
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9699
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2017
• 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 Age: 14 YR