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

Model Number MS8929

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Dizziness (2194); Underdose (2542)

Event Date 03/31/2015

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program who contacted the company to report an adverse event, concerns an (b)(6) year old female patient.Medical history not provided.Concomitant medications included metformin and historical medication included human insulin isophane suspension 70%/human insulin 30% (humulin 70/30) from 2007 to 2011.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (humalog mix 25; reusable humapen ergo i) at 20 units in the morning, 8 units at noon and 12 units in the evening for treatment of diabetes mellitus beginning on an unknown date in 2011.On an unknown date in (b)(6) 2015, the patient felt dizzy, blood glucose was high and was hospitalized.Blood glucose values, diagnostic results and treatment measures were not provided.On (b)(6) 2013, her postprandial blood glucose was 16 (normal values not provided).It was reported that sometimes due to the humapen ergo i (lot number 0407a02, product complaint (b)(4)) device failure, the patients injected dosage was not accurate and the injected dose was less than the prescribed dosage.The patient initiated use of the humapen ergo i (lot number 0407a02) in 2007 and had improperly used the device beyond 3 years; from 2007 to 2015.Also on an unknown date in 2010, the metal buckle part of the humapen ergo i was fractured however the patient continued to use the device.At the time of reporting, the patient remained hospitalized for treatment and her discharge was planned for around (b)(6) 2015.Treatment with insulin lispro protamine suspension 75%/insulin lispro 25% continued.It was unknown if the patient was a trained user of the device.The device duration of use was since 2007 and the problem device duration of use was unknown.Return status of the humapen ergo i reusable device was not provided.The reporting consumer related the events of dizziness and blood glucose was high to insulin lispro protamine suspension 75%/insulin lispro 25% and did not provide an opinion of relatedness for the non-serious event of postprandial blood glucose of 16.Update (b)(6) 2015: no new information was received.No updates were made to this case.Update (b)(6) 2015: product complaint number (b)(4) was received on (b)(6) 2015.Processed product complaint number and added it to the narrative.

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.

Manufacturer Narrative

Please refer to update statement dated 01jul2015.No further follow up is planned.Evaluation summary a patient reported that her humapen ergo device had a broken injection screw.She continued to use the device and thought the injected dose was less than the prescribed dose.She experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch 0407a02, manufactured july 2004).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 trends with regard to dose accuracy or broken injection screw.The patient reported that she had used the device since 2007 (8 years), which is beyond its approved use life.The user manual states the device was designed to be used for up to 3 years after first use.Additionally, the user manual states not to use the device if it appears broken or damaged and to contact lilly or your healthcare professional for a replacement pen.There is evidence of improper use.The patient used the device beyond its approved use life.In addition, the patient continued to use the device after it broke.This may be relevant to the complaint of increased blood glucose levels.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program who contacted the company to report an adverse event, concerns (b)(6) year old female patient.Medical history not provided.Concomitant medications included metformin and historical medication included human insulin isophane suspension 70%/human insulin 30% (humulin 70/30) from 2007 to 2011.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (humalog mix 25; reusable humapen ergo teal with clear cartridge holder) at 20 units in the morning, 8 units at noon and 12 units in the evening for treatment of diabetes mellitus beginning on an unknown date in 2011.On an unknown date in (b)(6) 2015, the patient felt dizzy, blood glucose was high and was hospitalized.Blood glucose values, diagnostic results and treatment measures were not provided.On (b)(6) 2013, her postprandial blood glucose was 16 (normal values not provided).It was reported that sometimes due to the humapen ergo teal with clear cartridge holder (lot number 0407a02, (b)(4)) device failure, the patients injected dosage was not accurate and the injected dose was less than the prescribed dosage.The patient initiated use of the humapen ergo teal with clear cartridge holder (lot number 0407a02) in 2007 and had improperly used the device beyond 3 years; from 2007 to 2015.Also on an unknown date in 2010, the metal buckle part of the humapen ergo teal with clear cartridge holder was fractured however the patient continued to use the device.It was clarified during follow up that it was the injection screw that was broken.At the time of reporting, the patient remained hospitalized for treatment and her discharge was planned for around (b)(6) 2015.Treatment with insulin lispro protamine suspension 75%/insulin lispro 25% continued.It was unknown if the patient was a trained user of the device.The device duration of use was since 2007 and the problem device duration of use was unknown.The device was not returned.The reporting consumer related the events of dizziness and blood glucose was high to insulin lispro protamine suspension 75%/insulin lispro 25% and did not provide an opinion of relatedness for the non-serious event of postprandial blood glucose of 16.Update 01jun2015: no new information was received.No updates were made to this case.Update 08jun2015: (b)(4) was received on 05jun2015.Processed product complaint number and added it to the narrative.Update 01jul2015.Additional information received on 30jun2015 from the global product complaint database added the device specific safety summary and manufactured date of the device; updated the device to a humapen ergo teal with clear cartridge holder based on the verified lot number; added that the device was not returned; updated the eu/ca fields and the medwatch fields; and updated the narrative.

• Brand Name: HUMAPEN ERGO, TEAL/CLEAR
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-ORIGEN; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 4840028
• MDR Text Key: 5875833
• Report Number: 1819470-2015-00044
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS8929
• Device Lot Number: 0407A02
• Other Device ID Number: 3342642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2004
• 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: INSULIN LISPRO; METFORMIN
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR