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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

No further follow up is planned.Evaluation summary the patient experienced blood glucose fluctuations while using a humapen savvio (lot unknown).There was no product complaint for the device and it was not returned for investigation there was evidence of improper use of the device.It was reported that the patient changed the needle of the humapen every week and thus reused needles, and had reduced eyesight.This is likely not relevant given that there was no product complaint relative to pen function.The device user manual indicates a new needle should be used with each injection and that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) caucasian female patient.Medical history included diabetes for 20 years, hypertensive and hyperthyroidism.Concomitant medications included three unspecified medications for hypertension, hypothyroidism and cough.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30) via reusable pen (humapen savvio) 38 iu daily, divided on three doses, one with each meal, subcutaneously for the treatment of diabetes mellitus beginning in 2009.Sometime while taking human insulin 70/30, she suffered from her eyes because her sight had been reduced and she also had unspecified problems with her nerves, bones and leg nerves.On an unknown date, she experienced fluctuation in her blood sugar and she suffered from coma every day, because her random blood sugar (rbs) decreased to 20-35-40 mg/dl and sometimes, after that, her rbs was on 400 mg/dl.It was also reported that when she ate sweets and normal food, her blood sugar (bs) remained low, but when she ate only normal food her blood sugar level increased.On an unknown date, her bs was on 270 mg/dl, then she took human insulin 70/30, her bs decreased to 30 mg/dl and she ate something sugary to increase.Her hba1c was on 8-9.On (b)(6) 2016, her fasting blood sugar (fbs) after waking up was on 126 mg/dl and after one hour, it was on 163 mg/dl.The patient was not recovered from the events.Human insulin 70/30 treatment was continued and she was changing the needle of her humapen savvio every week.Information regarding corrective treatment was not provided, but her treating physician advised her to increase her insulin dose if her bs was increased and decrease her insulin dose levels if her bs was decreased.The patient was the operator of the humapen savvio and her training status was not provided.The humapen savvio model duration of use and the suspect device duration of use were not provided.There was no reported complaint for this humapen savvio.The device was not returned.The reporting consumer did not provide an assessment of relatedness between the events and human insulin 70/30 or humapen savvio.Update 01jul2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 07jul2016: additional information received on 07jul2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• 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 IN 46285
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5779054
• MDR Text Key: 49133145
• Report Number: 1819470-2016-00167
• 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
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 07/08/2016
• 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
• Patient Age: 40 YR
• Patient Weight: 77