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

Model Number MS9699

Device Problems Device Inoperable (1663); Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

Narrative field - new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 21nov2016 in the narrative field.No further follow up is planned.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerns an (b)(6) female patient.The patient had no medical history.Information regarding concomitant medication was not provided.The patient received human insulin (rdna origin) 30% regular 70% nph (humulin 70n/30r) via reusable pen, three doses daily, reported as 14 iu at lunch and the other two dose values were unknown, subcutaneously, for diabetes, beginning on an unknown date reported as more than 20 years from the time of initial report on 08nov2016.In the end of (b)(6) 2016 the patient bought a pen humapen savvio gray (lot number 1406v06) in order to deliver the human insulin.In (b)(6) 2016, unknown time after beginning human insulin 30% regular 70% nph therapy via humapen savvio gray, the pen stopped to work, it was provided that when the patient pressed down the injection button it was jammed (product complaint number 3822752) and the patient sometimes received the dose and sometimes did not receive it (drug dose omission) and due to that on (b)(6) 2016 her diabetes was very high and reached more than 400 mg/dl (no normal range was provided).On (b)(6) 2016 the patient was hospitalized due to the very high glycemia and she was discharged from hospital on (b)(6) 2016 when she recovered from the blood glucose increased.No information about exams and corrective treatment was provided.It was also reported that the patient always reused the needles, she always performed the calibration procedure and stored the pen and human insulin 30% regular 70% nph cartridge in the refrigerator.Treatment with human insulin 30% regular 70% nph was continued.The patient operated the device and she was trained by a physician.The patient had used the reported device for approximately two months and this device model for unknown time.The device was not returned.The reporting consumer related the event of high glycemia to human insulin 30% regular 70% nph therapy.No other opinion of relatedness was provided.Update 11nov2016: upon review, this case was opened to update the medwatch fields for regulatory reporting.Update 21nov2016: additional information received on 21nov2016 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 (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: 6142416
• MDR Text Key: 61356993
• Report Number: 1819470-2016-00300
• 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
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9699
• Device Lot Number: 1406V06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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
• Treatment: HUMULIN
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR
• Patient Weight: 63