MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO, UNKNOWN PEN BODY TYPE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problems Poor Quality Image (1408); Difficult or Delayed Activation (2577); Programming Issue (3014)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer who contacted the company via a patient support program to report an adverse event, concerns a (b)(4) year old male patient.Medical history was not provided.Concomitant medication included acarbose.The patient received human insulin isophane suspension 70%/ human regular insulin 30% (humulin 70/30, unknown formulation) 20-0-16 df, via a reusable humapen ergo i device, for the treatment of type ii diabetes mellitus, beginning in 2005.In mid (b)(6) 2014, approximately nine years after starting treatment, the patient began to experience increased blood glucose.Two months later, on (b)(6) 2014, the patient was hospitalized due to blood glucose not controlled well.The fasting blood glucose was around 13 and postprandial glucose was around 13 to 14 (units not provided).During hospitalization, human insulin isophane suspension 70%/ human regular insulin 30% was increased to 28-0-24 df.Additional treatment included unspecified intravenous and other medications.Currently the patients fasting blood glucose was around 5 to 6 and postprandial glucose was around 6.7 to 11.The patient was still in the hospital at the time of the initial report on (b)(6) 2014.The patient considered he may have had drug resistance for human insulin isophane suspension 70%/ human regular insulin 30% due to its duration of use.The patient also complained that the button of his humapen ergo i was hard to press and the scale numbers on the pen became fuzzy, which caused difficulty in adjusting dosage (lot number not provided, associated 3154467).Additional information was not provided.The increased blood glucose was recovering, no outcome was provided for the insulin resistance.Treatment with human insulin isophane suspension 70%/ human regular insulin 30% continued.The general and problem device duration of use was nine years and it was unknown if the patient was a trained user.It was unknown if the device would be returned.The consumer reporter did not provide an opinion of relatedness.Update (b)(6) 2014: follow-up was received from the initial reporter on (b)(6) 2014.Added new non-serious event of insulin resistance.Updated narrative with new information.Update (b)(6) 2014: upon review of this case on (b)(6) 2014, the case was opened to update the medwatch and eu/ca fields.Update (b)(4) 2014: product complaint #(b)(4) was provided on (b)(4) 2014 and assigned to the case and to the narrative.No other updates made to 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

No further follow up is planned.Evaluation summary: a patient reported that it was difficult to push down the injection button of his humapen ergo device, and the number in the dosage window too blurry to adjust the dosage.He experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The patient had used the device for nine years.The user manual states the humapen ergo has been designed to be used for up to 3 years after first use.The user manual also instructs 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.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer who contacted the company via a patient support program to report an adverse event, concerns a (b)(6) male patient.Medical history was not provided.Concomitant medication included acarbose.The patient received human insulin isophane suspension 70%/ human regular insulin 30% (humulin 70/30, unknown formulation) 20-0-16 df, via a reusable humapen ergo i device, for the treatment of type ii diabetes mellitus, beginning in 2005.In mid (b)(6) 2014, approximately nine years after starting treatment, the patient began to experience increased blood glucose.Two months later, on (b)(6) 2014, the patient was hospitalized due to blood glucose not controlled well.The fasting blood glucose was around 13 and postprandial glucose was around 13 to 14 (units not provided).During hospitalization, human insulin isophane suspension 70%/ human regular insulin 30% was increased to 28-0-24 df.Additional treatment included unspecified intravenous and other medications.Currently the patients fasting blood glucose was around 5 to 6 and postprandial glucose was around 6.7 to 11.The patient was still in the hospital at the time of the initial report on (b)(6) 2014.The patient considered he may have had drug resistance for human insulin isophane suspension 70%/ human regular insulin 30% due to its duration of use.The patient also complained that the button of his humapen ergo i was hard to press and the scale numbers on the pen became fuzzy, which caused difficulty in adjusting dosage (lot number not provided, associated 3154467).Additional information was not provided.The increased blood glucose was recovering, no outcome was provided for the insulin resistance.Treatment with human insulin isophane suspension 70%/ human regular insulin 30% continued.The general and problem device duration of use was nine years and it was unknown if the patient was a trained user.The device was not returned.The consumer reporter did not provide an opinion of relatedness.Update 23oct2014: follow-up was received from the initial reporter on 22oct2014.Added new non-serious event of insulin resistance.Update 29oct2014: upon review of this case on 29oct2014, the case was opened to update the medwatch.Update 31oct2014: product complaint #3154467 was provided on 31oct2014 and assigned to the case and to the narrative.No other updates made to narrative.Update 07nov2014: additional information received on 06nov2014 from the global product complaint database added the device specific safety summary and that the device was not returned; updated the improper use and storage to yes; updated the medwatch.

• Brand Name: HUMAPEN ERGO, UNKNOWN PEN BODY TYPE
• 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: john fredenburg ; lilly corporate center; indianapolis, IN 46285 ; 3172770207
• MDR Report Key: 4229637
• MDR Text Key: 4997130
• Report Number: 1819470-2014-00061
• 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: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Other Device ID Number: 3154467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 HUMAN; ACARBOSE TABLET
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 75