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

Model Number MS9698

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

Device not returned.Usage concerns resolved, and device was reported to be working properly.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 compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report a product complaint, concerns a female patient of unknown age and ethnicity.No medical history or concomitant medications were provided.The patient received human insulin (rdna origin) nph (humulin n), via humapen savvio (graphite), unknown dose, frequency, route of administration, indication of use and start date.On an unknown date, unknown time after human insulin therapy start, the patient experienced a hypoglycemia and hyperglycemia crisis.During one of the hypoglycemia crisis, which was considered as serious by the company due to medically significant reasons, the patient had to go to the hospital.No further details were provided.On (b)(6) 2019, the patients blood sugar was 500 (units and normal ranges not provided).In addition, it was reported the patients humapen savvio was not working; the patient would press the injection button until the end, but the insulin would not come out.A new needle was attached so that tests in line could proceed and the insulin was normally coming out of the device.No other corrective treatments or laboratorial tests were provided.The patients recovery state was unknown, such as current human insulin therapy status.The patient operated the device and it was unknown if she was trained.This device model had been used for three years, such as the suspected device.Return will not be expected since the product complaint was resolved in line and usage status was unknown.No opinion of relatedness was provided.Edit 18dec2019: upon internal medical review regarding the initial case received on 12dec2019, the hypoglycemia crisis event was conservatively upgraded to serious and the coding for the blood glucose increase changed to hyperglycemia.Narrative and corresponding fields were updated accordingly.Edit 24dec2019: updated medwatch fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report a product complaint, with additional information received from the initial consumer, concerns a female patient of unknown age and ethnicity.No medical history or concomitant medications were provided.The patient received human insulin (rdna origin) nph (humulin n), via humapen savvio (graphite), unknown dose, frequency, route of administration and indication of use, beginning approximately in 2015.On an unknown date, unknown time after human insulin therapy start, the patient experienced a hypoglycemia and hyperglycemia crisis (crises of both hypo and hyperglycemia).On approximately (b)(6) 2019, the patient experienced one of the hypoglycemia crisis, which was considered as serious by the company due to medically significant reasons, and the patient had to go to the hospital.It was reported that the patient was medicated with unknown medications and went out on the same day from the hospital, without being hospitalized.On (b)(6) 2019, the patients blood sugar was 500 (units and normal ranges not provided).Since (b)(6) 2019, the patient had her glycemia increased and due to that, she went to a physician consult, in which the insulin dose was increased and exams were requested to a consult return in (b)(6) 2020.In addition, it was reported the patients humapen savvio was not working; the patient would press the injection button until the end, but the insulin would not come out (pc: (b)(4), lot 1407v06).A new needle was attached so that tests in line could proceed and the insulin was normally coming out of the device.No other additional corrective treatments or laboratorial tests were provided.As of (b)(6) 2020, the patient had recovered from the event of hypoglycemia.No outcome was provided for the event of hyperglycemia.The insulin therapy status was unknown.The patient operated the device and it was unknown if she was trained.This device model had been used for three years, such as the suspected device.Return will not be expected since the product complaint was resolved in line and usage status was unknown.The suspect humapen savvio (graphite) device associated with product complaint (b)(4) was not returned to the manufacturer.No opinion of relatedness was provided.Edit (b)(6) 2019: upon internal medical review regarding the initial case received on (b)(6) 2019, the hypoglycemia crisis event was conservatively upgraded to serious and the coding for the blood glucose increase changed to hyperglycemia.Narrative and corresponding fields were updated accordingly.Edit (b)(6) 2019: updated medwatch fields for expedited device reporting.No new information added.Update 06jan2020: additional information received from the initial reporting consumer on 03jan2020.Added information regarding start date of treatment with human insulin.Updated action taken to dose increased for human insulin treatment.Added onset dates for the event of hypoglycemia.Added recovered outcome for the event of hypoglycemia.Added information regarding corrective treatments.Added information that the patient was not hospitalized.Narrative and corresponding fields were updated accordingly.Update 10jan2020: additional information received on 09jan2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information, and malfunction from unknown to no.Added date of manufacturer for the suspect humapen savvio (graphite) device associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.

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 dated 10jan2020 in the b.5.Field.This is a downgrade report, which no longer meets the criteria for expedited reporting.No further follow-up is planned.Evaluation summary: a female patient reported that her humapen savvio device was not working.The patient pressed the injection button until the end, but the insulin would not come out.In (b)(6) 2019, the patient experienced a serious event of hypoglycemia.On (b)(6) 2019, the patient experienced a non-serious event of hyperglycemia.The device was not returned to the manufacturer for investigation (batch 1407v06, manufactured (b)(6) 2014).Troubleshooting was performed with guidance from a trained professional and the insulin was delivered.A complaint history review of the batch did not identify any atypical findings with regard to dose accuracy issues.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.

• Brand Name: HUMAPEN SAVVIO 3ML (GRAPHITE)
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 9565108
• MDR Text Key: 186608210
• Report Number: 1819470-2019-00230
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9698
• Device Lot Number: 1407V06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other