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

Model Number MS9557

Device Problem No Flow (2991)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Vascular System (Circulation), Impaired (2572)

Event Date 01/31/2013

Event Type  Injury  

Manufacturer Narrative

This is an initial report.A follow-up report will be submitted when the final evaluation is completed.This report is associated with 1819470-2016-00285, 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) female han patient.Medical history included a hospitalization because of heart insufficient blood supply and blood glucose high (no values) in 2007.Concomitant medications were not reported.The patient received human insulin (rdna origin) injections (humulin 100 u/ml) through a cartridge via a reusable pen (humapen ergo ii) subcutaneously for the treatment of diabetes mellitus beginning in 2007.Dose and frequency were not reported.On an unspecified date in 2008 she had hypertension.On an unspecified date in 2013, because of a humapen ergo ii breakdown she did not administer human insulin.The breakdown was described as no insulin "flew out of the humapen" ((b)(4)/ lot 0902d05).On an unspecified date in 2013 she was hospitalized for high blood glucose (no values) and because her whole body had no strength.As a result of the humapen ergo ii breakdown, she discontinued the use of the device, and began using a second humapen ergo ii.In (b)(6) 2016, she again had a complaint that no insulin "flew out of the humapen" ((b)(4)/lot 1112d02).Insulin was released when the device was primed.She was hospitalized for the same reasons again in (b)(6) 2016.As a result of the complaint, the second humapen ergo ii was discontinued in (b)(6) 2016.Information regarding corrective treatment and outcome of the events was not reported.Human insulin treatment was continued.The user of the humapen ergo ii and his/her training status were unknown.The general humapen ergo ii duration of use was of approximately nine years.The suspect humapen ergo ii durations of use were of approximately three years.The first humapen ergo ii was discontinued on 2013 and the second humapen ergo ii was discontinued in (b)(6) 2016.The status of the devices was not provided.The reporting consumer did not know if the events were related to human insulin or the humapen.Update 27oct2016: upon review, the case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting; and added the product complaint numbers and product complaint information to the narrative.Update 31oct2016: additional information received on 31oct2016 from global product complaint database updated the lot number from unknown to 0902d05 for (b)(4); and from unknown to 1112d02 for (b)(4).The product tabs for humapen ergo ii and the narrative were updated.Edit 31-oct-2016: upon review changed description as reported for event of drug dose omission.

Manufacturer Narrative

Narrative - new, updated and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement dated 23nov2016 in describe event or problem.No further follow up is planned.This report is associated with 1819470-2016-00285, since there is more than one device implicated.Evaluation summary a female patient reported no insulin "flew out of the humapen" ergo ii device, and the patient did not administer any insulin.The patient experienced increased blood glucose.The investigation of the returned device (batch 0902d05, manufactured february 2009) found that the device met functional requirements and met dose accuracy glide force specifications.No malfunction was identified.The investigation of the returned device found the body was cracked near the lens / bezel; this damage was consistent with exposure to excessive force while in the field.In addition, the discolored and detached soft touch indicated the device had been exposed to an unknown chemical while in the field.The damage observed to the ergo ii device did not affect the functionality of the device.The user manual describes the proper care and storage of the device and states "do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen." in addition, the user manual instructs the patient to not use the device if it appears broken or damaged and to contact lilly or their healthcare provider for a replacement pen.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability.There is evidence of improper use or storage.The body was cracked near the lens / bezel due to excessive force while in the field (not related to the manufacturing process).In addition, the soft touch was discolored and detached due to exposure to an unknown chemical while in the field (not related to the manufacturing process).

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female han patient.Medical history included a hospitalization because of heart insufficient blood supply and blood glucose high (no values) in 2007.Concomitant medications were not reported.The patient received human insulin (rdna origin) injections (humulin 100 u/ml) through a cartridge via a reusable pen (humapen ergo ii) subcutaneously for the treatment of diabetes mellitus beginning in 2007.Dose and frequency were not reported.On an unspecified date in 2008 she had hypertension.On an unspecified date in 2013, because of a humapen ergo ii breakdown she did not administer human insulin.The breakdown was described as no insulin "flew out of the humapen" ((b)(4)/ lot 0902d05).On an unspecified date in 2013 she was hospitalized for high blood glucose (no values) and because her whole body had no strength.As a result of the humapen ergo ii breakdown, she discontinued the use of the device, and began using a second humapen ergo ii.In (b)(6) 2016, she again had a complaint that no insulin "flew out of the humapen" ((b)(4)/lot 1112d02).Insulin was released when the device was primed.She was hospitalized for the same reasons again in (b)(6) 2016.As a result of the complaint, the second humapen ergo ii was discontinued in (b)(6) 2016.Information regarding corrective treatment and outcome of the events was not reported.Human insulin treatment was continued.The user of the humapen ergo ii and his/her training status were unknown.The general humapen ergo ii duration of use was of approximately nine years.The suspect humapen ergo ii durations of use were of approximately three years.The first humapen ergo ii was discontinued on 2013 and the second humapen ergo ii was discontinued in (b)(6) 2016.The both devices were returned on 31oct2016, and no malfunctions were found.The reporting consumer did not know if the events were related to human insulin or the humapen.Update 27oct2016: upon review, the case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting; and added the product complaint numbers and product complaint information to the narrative.Update 31oct2016: additional information received on 31oct2016 from global product complaint database updated the lot number from unknown to 0902d05 for (b)(4); and from unknown to 1112d02 for (b)(4).The product tabs for humapen ergo ii and the narrative were updated.Edit 31-oct-2016: upon review changed description as reported for event of drug dose omission.Update 22-nov-2016: additional information received from the affiliate on 21-oct-2016 with (b)(4).No adverse event or product information was received.No changes were made.Update 23nov2016: additional information received on 23nov2016 from the global product complaint database added the device specific safety summary, manufactured date, and return date of both devices; updated the malfunction field to no for both devices; updated the improper use and storage to yes for the device associated with (b)(4); updated the medwatch and european and canadian required device reporting elements for both devices; and updated the narrative.

• Brand Name: HUMAPEN ERGO II
• 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: 6078932
• MDR Text Key: 59186659
• Report Number: 1819470-2016-00284
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• 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: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0902D05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2009
• 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: 52 YR
• Patient Weight: 67