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

Model Number MS9694

Device Problem Break (1069)

Patient Problems Missed Dose (2561); No Code Available (3191)

Event Date 02/06/2019

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 report is associated with (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of unspecified origin.Medical history included hypertension (2016).Concomitant medications were not provided.The patient received human insulin isophane suspension (rdna origin) (humulin n, cartridge) via humapen savvio red, 10 iu each in morning and night, subcutaneously for the treatment of diabetes beginning on an unknown date in 2016.She also received human insulin (rdna) (humulin r) via unknown formulation, thrice daily (20 iu in morning, 10 iu before lunch and 15 iu at night), from unknown route for the treatment of diabetes beginning on an unknown date in 2016.On (b)(6) 2019 after starting human insulin isophane suspension and human insulin therapies the cartridge holder of humapen savvio was broken due to which she missed doses of human insulin isophane suspension (b)(4), lot number unknown) and as of (b)(6) 2019 she was still missing them.She went into diabetic coma on (b)(6) 2019.The event of diabetic coma was considered serious due to its medical significance.Previously she also went into diabetic coma every three to four days due to missing her doses (reason unspecified).Corrective treatment was not provided.Outcome of the second episodes of missed dose and diabetic coma (related to product complaint) was not recovered and for the remaining events was not provided.Status of human insulin isophane suspension and human insulin therapies was ongoing.The operator of the humapen savvio red was patient and training status of operator was not provided.The general and suspect humapen savvio red duration of use was two years (approximately).The suspect device was continued and its return was expected.The reporting consumer assessed the events as not related to human insulin isophane suspension therapy and did not provide relatedness assessment between the events and human insulin therapy.The reporting consumer assessed the missed dose due to product complaint was related to humapen savvio red and did not provide relatedness assessment between the remaining events and humapen savvio red.Edit (b)(4) 2019: updated medwatch and european and (b)(6) fields for expedited device reporting.No new information added.No new information added.Edit (b)(4) 2019: upon review of information received regarding product complaint, (b)(4) was updated in narrative.No other changes were done to the case.

Manufacturer Narrative

Event narrative field: new, updated and corrected information is referenced within the update statements in event.Please refer to update statement dated 28feb2019 in the event field.No further follow-up is planned.Evaluation summary: a female patient reported the cartridge holder of her humapen savvio device was broken.Due to this, she missed doses.She experienced diabetic coma.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.The core instructions for use state to always carry a spare insulin pen in case your pen is lost or damaged.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information from the reporting consumer, concerned a 26-year-old female patient of unspecified origin.Medical history included hypertension (2016).Concomitant medications were not provided.The patient received human insulin isophane suspension (rdna origin) (humulin n, cartridge) via a reusable humapen savvio (red) device, 10 iu each in morning and night, subcutaneously for the treatment of diabetes beginning on an unknown date in 2016.She also received human insulin (rdna) (humulin r) via an unknown formulation, thrice daily (20 iu in morning, 10 iu before lunch and 15 iu at night), from unknown route for the treatment of diabetes beginning on an unknown date in 2016.On (b)(6) 2019, after starting human insulin isophane suspension and human insulin therapies the cartridge holder of humapen savvio was broken due to which she missed doses of human insulin isophane suspension (pc number: (b)(6), lot number: unknown) and as of on (b)(6) 2019 she was still missing them.She went into diabetic coma on (b)(6) 2019.The event of diabetic coma was considered serious due to its medical significance.Her blood glucose level was in the range from 200 mg/dl to 300 mg/dl during the diabetic coma (normal reference range was not provided).Previously she also went into diabetic coma every three to four days due to missing her doses (reason unspecified).Corrective treatment was not provided.Outcome of the second episodes of missed dose and diabetic coma (related to product complaint) was not recovered and for the remaining events was not provided.Status of human insulin isophane suspension and human insulin therapies was ongoing.The operator of the humapen savvio (red) device was the patient and training status of operator was not provided.The general and suspect humapen humapen savvio (red) device duration of use was two years (approximately).The suspect device was continued and was not returned to the manufacturer.The reporting consumer assessed the events as not related to human insulin isophane suspension therapy and did not provide relatedness assessment between the events and human insulin therapy.The reporting consumer assessed the missed dose due to product complaint was related to humapen savvio red and did not provide relatedness assessment between the remaining events and humapen savvio red.Edit on 14feb2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 21-feb-2019: upon review of information received regarding product complaint, pc number: (b)(6) was updated in narrative.No other changes were done to the case.Update 28feb2019: additional information received on 28feb2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, and device return status to not returned to manufacturer for (b)(6) associated with an unknown lot of humapen savvio (red) device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN SAVVIO 3ML (RED)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8370308
• MDR Text Key: 137248319
• Report Number: 1819470-2019-00020
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9694
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR