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

Model Number MS9695

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Fall (1848); Hyperglycemia (1905); Hypoglycemia (1912); Nausea (1970); Overdose (1988); Seizures (2063); Malaise (2359); Loss of consciousness (2418)

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)(6).This report is associated with product compliant: pending.This spontaneous case, reported by a consumer, who contacted the company to report an adverse event, concerned a female patient of unknown age and origin.Medical history was not provided.Concomitant medication included insulin glargine for unknown indication.The patient received insulin lispro (rdna origin) (humalog 100u/ml) cartridge via reusable pens including a humapen savvio.Dosage regimen, route of administration, indication for use and start date were not provided.On an unspecified date, she took one extra unit and her blood glucose level went down to four (units not provided), she passed out on the floor because she took too much insulin.Reportedly, her reactions were extreme when she got less or more insulin.On an unspecified date, she was convulsing because her glucose was so low, crashed into a table, fell over the floor and started screaming; someone heard her and gave her something to eat.As a result she was bruised.The events of hypoglycemic seizure and hypoglycemic unconsciousness were considered serious due to its medical significance.The patient could not remember if she had taken her insulin lispro or not.Reportedly, in other occasions her reactions were terrible and frightening that she gets so high, nauseous and so sick (as reported).For the patient humapen savvio was a terrible pen, she had also tried timesulin but it did not work for her.Information regarding corrective treatment, outcome of the events and insulin lispro treatment status was not provided.The operator of the humapen savvio and her/his training status was not provided.The humapen savvio model and suspect humapen savvio duration of use was not reported.The action taken with the suspect device was not provided.The reporting consumer considered the events nausea and malaise were not related to insulin lispro therapy, and did not provide an opinion of relatedness between the remaining events and insulin lispro treatment or the humapen savvio.This case was cross-referenced to the following case: (b))(6).(same reporter) updated (b)(6) 2017: 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 update statement dated 29aug2017.No further follow-up is planned.Evaluation summary: a female patient experienced hypoglycemic seizure and hypoglycemic unconsciousness while using a humapen savvio device.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 compliant: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and product complaint (pc), concerned a female patient of unknown age and origin.Medical history was not provided.Concomitant medication included insulin glargine for unknown indication.The patient received insulin lispro (rdna origin) (humalog 100u/ml) cartridge via reusable pens including a humapen savvio (blue).Dosage regimen, route of administration, indication for use and start date were not provided.On an unspecified date, she took one extra unit and her blood glucose level went down to four (units not provided), she passed out on the floor because she took too much insulin.Reportedly, her reactions were extreme when she got less or more insulin.On an unspecified date, she was convulsing because her glucose was so low, crashed into a table, fell over the floor and started screaming; someone heard her and gave her something to eat.As a result, she bruised.The events of hypoglycemic seizure and hypoglycemic unconsciousness were considered serious due to its medical significance.The hypoglycemic seizure and hypoglycemic unconsciousness reportedly occurred while using her humapen savvio (blue) device (pc: (b)(4) batch: unknown).In addition, she could not remember if she had taken her insulin lispro or not.Reportedly, in other occasions her reactions were terrible and frightening that she got so high, nauseous and so sick (as reported).For the patient noted that the humapen savvio was a terrible pen and she had also tried timesulin but it did not work for her.Information regarding corrective treatment, outcome of the events, and insulin lispro treatment status was not provided.The operator of the humapen savvio and her/his training status was not provided.The humapen savvio model and suspect humapen savvio duration of use was not reported.The action taken with the suspect device was not provided.The humapen savvio was not returned to the manufacturer.The reporting consumer considered the events nausea and malaise were not related to insulin lispro therapy, and did not provide an opinion of relatedness between the remaining events and insulin lispro treatment or the humapen savvio.This case was cross-referenced to the following case: (b)(4) (same reporter).Updated 28jul2017: updated medwatch fields for expedited device reporting.No new information added.Edit 14-aug-2017: information received from the responsible complaint personnel on 14-aug-2017.The suspect device was changed from humapen savvio unknown color to humapen savvio blue.Product complaint (b)(4) was processed and added to the narrative.No further changes made in the case.Update 29aug2017: additional information received on 27aug2017 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 (blue) device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (BLUE)
• 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: 6786431
• MDR Text Key: 82477331
• Report Number: 1819470-2017-00140
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2017
• 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): Other