MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO, BURGUNDY/CLEAR; FOR TREATMENT PURPOSES

Model Number MS8930

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 11/30/2016

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 spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned an (b)(6) male patient of unknown origin.Medical history and concomitant medications were not reported.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) via cartridge through a reusable pen (humapen ergo burgundy with clear cartridge holder), 36 units daily, divided in 28 each morning and 8 each evening, for the treatment of diabetes beginning on (b)(6) 2001.On approximately (b)(6) 2016 (reported as a month ago since the report of (b)(6) 2016), when he administered insulin lispro protamine suspension 75%/ insulin lispro 25%, the humapen ergo pulled more insulin than it should ((b)(4) lot 40203).Because of that, he suffered hypoglycemia and almost loss of consciousness.The events of hypoglycemia and semi-consciousness were considered serious due to medical significance.As corrective treatment his wife gave him sugar in order to help elevating the sugar levels.He had recovered from the events.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment was continued.The operator of the humapen ergo was the patient and his training status was unknown.The general duration of use for the humapen ergo model was not provided, but started on (b)(6) 2001.The duration of use for the suspect device was not provided.By (b)(6) 2016, it was unknown if the currently humapen ergo remained in use.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro protamine suspension 75%/ insulin lispro 25% treatment or the humapen ergo, but believed that they were due to the humapen ergo was delivering more insulin than it should.Update 12dec2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: the granddaughter of a male patient reported that his humapen ergo device dispensed more insulin than it was supposed to when it was dialed to 8 units.He experienced decreased blood glucose.The device was not returned to the manufacturer for investigation (batch 40203, manufactured january 2002).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with regard to dose accuracy.While the exact date when the patient started using the device could not be determined, based on the amount of time elapsed since this device was manufactured (2002), it is likely that the patient used it beyond its approved use life.The user manual states the humapen ergo device has been designed to be used for up to 3 years after first use.There is evidence of improper use.Based on the manufacture date, it is likely the patient used the device beyond the recommended use period.It is unknown if is this is relevant to the event of decreased blood glucose.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned an (b)(6) male patient of unknown origin.Medical history and concomitant medications were not reported.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) via cartridge through a reusable pen (humapen ergo burgundy with clear cartridge holder), 36 units daily, divided in 28 each morning and 8 each evening, for the treatment of diabetes beginning on (b)(6) 2001.On approximately (b)(6) 2016 (reported as a month ago since the report of 06-dec-2016), when he administered insulin lispro protamine suspension 75%/ insulin lispro 25%, the humapen ergo pulled more insulin than it should (product complaint (b)(4) lot 40203).Because of that, he suffered hypoglycemia and almost loss of consciousness.The events of hypoglycemia and semi-consciousness were considered serious due to medical significance.As corrective treatment his wife gave him sugar in order to help elevating the sugar levels.He had recovered from the events.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment was continued.The operator of the humapen ergo was the patient and his training status was unknown.The general duration of use for the humapen ergo model was not provided, but started on (b)(6) 2001.The duration of use for the suspect device was reported as three years, but it was manufactured in jan-2002.The device was not returned.The reporting consumer did not provide a relatedness assessment between the events and insulin lispro protamine suspension 75%/ insulin lispro 25% treatment or the humapen ergo, but believed that they were due to the humapen ergo was delivering more insulin than it should.Update 12dec2016: upon review, this case was opened to update the medwatch and (b)(6) required device reporting elements for regulatory reporting.Update 09jan2017: additional information received on 09jan2017 from the global product complaint database added the device specific safety summary and the manufactured date of the device; added the device was not returned; updated the improper use and storage to yes; updated the suspect device duration of use; updated the medwatch and (b)(6) required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN ERGO, BURGUNDY/CLEAR
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6180697
• MDR Text Key: 62604832
• Report Number: 1819470-2016-00331
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K982842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS8930
• Device Lot Number: 40203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2002
• 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: HUMALOG
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 58