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

Model Number UNKNOWN

Device Problems Positioning Failure (1158); Mechanical Problem (1384)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

There was no reported complaint for this device and its return is not expected.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2016-00312, since there is more than one device implicated.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of asian origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injection (humulin 70/30 iu300) cartridge via reusable pen (humapen ergo unknown body type), 20u in the morning and 18u evening daily, subcutaneously for the treatment of diabetes mellitus beginning in 2004.On an unreported date in 2012, the humapen ergo had an unspecified malfunction ((b)(4)/ lot unknown) and was replaced with a humapen ergo ii.Sometime in 2012 he was hospitalized to adjust his blood glucose and after half month he was discharged.In (b)(6) 2016, the injection screw would not move out on his humapen ergo ii ((b)(4)/lot 0803d06.On (b)(6) 2016 he was hospitalized to adjust his blood glucose again and would be discharged from the hospital on (b)(6) 2016.Additional information regarding corrective treatment was not provided.Outcome of the evens was unknown.Human insulin isophane suspension 70%/ human insulin 30% treatment status was ongoing.The operator of the devices and his/her training status was unknown.The general device duration of use for the first device was approximately eight years, from 2004 to 2012 and the suspect device duration of use was eight years.The action taken with the suspect device was not provided and its return was not expected.The general device duration of use for the second device was approximately four years, beginning in 2012 and the suspect device duration of use was four years.The device remained in use, and would not be returned.The reporting consume did not know if the events were related to human insulin isophane suspension 70%/ human insulin 30% treatment and did not provide an assessment of relatedness for the suspect devices.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Update 18-nov-2016: upon review of original source information from (b)(6) 2016 to update the 1st suspect device to a humapen ergo unknown body type; added the product complaint information and product complaint numbers to the case; updated the causality for the devices; updated the narrative; and completed the medwatch and european and canadian required device reporting elements.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a male patient reported his humapen ergo device malfunctioned.He experienced abnormal 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 used the device for approximately 8 years.The user manual states the humapen ergo has been designed to be used for up to 3 years after first use.In addition, the user manual 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.It is unknown if this is relevant to the event of abnormal blood glucose levels.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of asian origin.Medical history and concomitant medications were not reported.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injection (humulin 70/30 iu300) cartridge via reusable pen (humapen ergo unknown body type), 20u in the morning and 18u evening daily, subcutaneously for the treatment of diabetes mellitus beginning in 2004.On an unreported date in 2012, the humapen ergo had an unspecified malfunction (product complaint (b)(4)/ lot unknown) and was replaced with a humapen ergo ii.Sometime in 2012 he was hospitalized to adjust his blood glucose and after half month he was discharged.In (b)(6) 2016, the injection screw would not move out on his humapen ergo ii (product complaint (b)(4)/lot 0803d06.On (b)(6) 2016 he was hospitalized to adjust his blood glucose again and would be discharged from the hospital on (b)(6) 2016.Additional information regarding corrective treatment was not provided.Outcome of the evens was unknown.Human insulin isophane suspension 70%/ human insulin 30% treatment status was ongoing.The operator of the devices and his/her training status was unknown.The general device duration of use for the first device was approximately eight years, from 2004 to 2012 and the suspect device duration of use was eight years.The device was not returned.The general device duration of use for the second device was approximately four years, beginning in 2012 and the suspect device duration of use was four years.The device was not returned.The reporting consume did not know if the events were related to human insulin isophane suspension 70%/ human insulin 30% treatment and did not provide an assessment of relatedness for the suspect devices.No follow-up would be requested since the reporter refused to provide more information.Treating physician contact details not provided.Update 18-nov-2016: upon review of original source information from 14-nov-2016 to update the 1st suspect device to a humapen ergo unknown body type; added the product complaint information and product complaint numbers to the case; updated the causality for the devices; updated the narrative; and completed the medwatch and european and canadian required device reporting elements.Update 14-dec-2016: additional information received on 13-dec-2016 from the global product complaint database added the device specific safety summary and manufactured date for the humapen ergo ii; added the device was not returned; updated the improper use and storage to yes; updated the medwatch and european and canadian required device reporting elements; and update the narrative.Update 15-dec-2016: additional information received on 17-nov-2016 from the product complaint database added no new information to the case.Update 15dec2016: additional information received on 14dec2016 from the global product complaint database added the device specific safety summary for the humapen ergo unknown body type; added the device was not returned; updated the improper use and storage to yes; updated the medwatch and european and canadian required device reporting elements; and update the narrative.

• 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-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: 6147525
• MDR Text Key: 61539143
• Report Number: 1819470-2016-00311
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2016
• 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
• Treatment: INSULIN HUMAN
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 70