MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO; FOR TREATMENT PURPOSES

Model Number MS8929

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Pain (1994); Numbness (2415); Sweating (2444); Weight Changes (2607)

Event Date 01/31/2012

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 and present a product complaint, concerned a (b)(6), asian, female patient.Medical history and concomitant medications were not reported.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) via reusable pen (humapen ergo), 12-14 units each morning and 6 units each evening, subcutaneously, for the treatment of diabetes mellitus, beginning in 2005.Since 2007 or 2008, her blood glucose levels could never be dropped.Also, she would experience pain in the injection sites (abdomen) after each injection.This could be caused by pen breakdown (product complaint number (b)(4)/lot 0504a03) or her thinness.On unspecified dates, she would experience symptoms of hypoglycemia (head numb, sweating) when going out for a walk at night.In 2012 or 2013, she was hospitalized because of high blood glucose and weight decreased significantly.Because of this, her dosage regimen was changed to 8 units each morning and 4 units each evening.Further information regarding corrective treatment was not provided.Outcome of the events was not provided.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment was ongoing.The user of the humapen ergo and its training status was not provided.The humapen ergo model was nine years and started since 2005.The device continued in use.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy or the device.Update 14sep2016: upon review, the case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting; updated the improper use and storage to yes based on the previously captured duration of use of nine years; and updated the status of the device to continued in use based on the original source.Edit 28-sep-2016: processed pc and added pc number to narrative.

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.Evaluation summary a female patient reported that the injection button on her humapen ergo device was difficult to push down.She experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 0504a03, manufactured april 2005).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 high injection force or dose accuracy.The patient started using the device in 2005.The user manual states the humapen ergo has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the approved use life.It is unknown if is this is relevant to the event of increased blood glucose.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event and present a product complaint, concerned a (b)(6) female patient.Medical history and concomitant medications were not reported.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) via reusable pen (humapen ergo), 12-14 units each morning and 6 units each evening, subcutaneously, for the treatment of diabetes mellitus, beginning in 2005.Since 2007 or 2008, her blood glucose levels could never be dropped.Also, she would experience pain in the injection sites (abdomen) after each injection.This could be caused by pen breakdown (pc (b)(4), batch 0504a03) or her thinness.On unspecified dates, she would experience symptoms of hypoglycemia (head numb, sweating) when going out for a walk at night.In 2012 or 2013, she was hospitalized because of high blood glucose and weight decreased significantly.Because of this, her dosage regimen was changed to 8 units each morning and 4 units each evening.Further information regarding corrective treatment was not provided.Outcome of the events was not provided.Insulin lispro protamine suspension 75%/ insulin lispro 25% treatment was ongoing.The user of the humapen ergo and its training status was not provided.The humapen ergo model was nine years and started since 2005.The device continued in use and its return status was unknown.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy or the device.Update 14sep2016: upon review, the case was opened to update the medwatch and (b)(4) required device reporting elements for regulatory reporting; updated the improper use and storage to yes based on the previously captured duration of use of nine years; and updated the status of the device to continued in use based on the original source.Edit 28-sep-2016: processed pc and added pc number to narrative.Update 11oct2016.Additional information received 11oct2016 from the product complaint safety database.To the device tab added the manufacture date, added the device specific safety summary (dsss), updated (b)(4) device information, updated the device medwatch information, and the narrative was updated accordingly.Updated 20-oct-2016: pc number (b)(4) was received from affiliate on 08-sep-2016.Pc already processed.No further changes were performed to the case.

• Brand Name: HUMAPEN ERGO
• 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: 5987340
• MDR Text Key: 55987396
• Report Number: 1819470-2016-00250
• Device Sequence Number: 1
• Product Code: NSC
• 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: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS8929
• Device Lot Number: 0504A03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2005
• 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): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 35