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

Model Number MS9557

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Dizziness (2194)

Event Date 10/31/2014

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.This report is associated with 1819470-2011-00058, 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) year-old (b)(6) male patient.Medical history was reported as none.Concomitant medications included metformin for unknown indication.The patient received human insulin isophane suspension 70% human insulin 30% (humulin 70/30) from a cartridge via a reusable pen (humapen ergo ii), 30 units in the morning and 15 units in the evening twice a day subcutaneously, for the treatment of diabetes mellitus, beginning in 2008.First humapen ergo ii was used from (b)(6) 2008 to (b)(6) 2016.Second humapen ergo ii was used from 2010 and continued.In (b)(6) 2014, he had high blood pressure caused by cervical, appeared dizziness and unstable blood sugar (fasting blood glucose was 13 and postprandial blood glucose was 20), which resulting in hospitalization.In (b)(6) 2014, he was discharged.By (b)(6) 2016, his blood sugar was still higher, fasting blood glucose was 10 to 13, postprandial blood glucose was 18 to 20.The button of first humapen ergo ii had problem in (b)(6) 2016 (product complaint (b)(4)/lot 1104d02).Button of second humapen ergo ii had problem in (b)(6) 2015 (product complaint (b)(4)/lot 1101d02).The corrective treatment and outcome of all the events were not provided.Human insulin 70/30 therapy was continued.The operator of the humapens ergo ii and his/ her training status were not provided.The general duration of use of the first humapen ergo ii and the duration of use of the first suspect humapen ergo ii were six years.The general duration of use of the second humapen ergo ii and the duration of use of the second suspect humapen ergo ii were four years.If devices were returned, evaluation would be performed.The reporting consumer did not know if the events were related to human insulin 70/30 therapy.Edit (b)(6) 2016: upon internal review case was unlocked via a non-med sig edit to return the case to the correct priority (back to p1 as the case contains a suspect reusable device with a serious indicator).Update (b)(6) 2016: upon review, the case was opened to update the medwatch fields for regulatory reporting; added the product complaints with lot numbers; and updated the narrative.

Manufacturer Narrative

New updated and corrected information is referenced within the update statements.Please refer to statement dated 29mar2016.This report is associated with 1819470-2011-00058, since there is more than one device implicated.Evaluation summary: a male patient reported that the injection button of his humapen ergo ii device could not be pushed down.He experienced increased blood glucose levels.The investigation of the returned device (batch (b)(4), manufactured april 2011) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient reported using the suspect humapen ergo ii device for six years.The humapen ergo ii user manual states the device was designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond its approved use life; however, the extended use is not relevant to this case as the device met dose accuracy and glide (injection) force specifications.

Event Description

(b)(4) this solicited case, reported by a consumer via a patient support program (psp),with additional information from the initial reporter, concerned a (b)(6) chinese male patient.Medical history was reported as none.Concomitant medications included metformin for unknown indication.The patient received human insulin isophane suspension 70% human insulin 30% (humulin 70/30) from a cartridge via a reusable pen (humapen ergo ii), 30 units in the morning and 15 units in the evening twice a day subcutaneously, for the treatment of diabetes mellitus, beginning in 2008.First humapen ergo ii was used from (b)(6) 2008 to (b)(6) 2016.Second humapen ergo ii was used from 2010 and continued.On an unspecified date he had a cervical vertebra compression, which caused in (b)(6) 2014 high blood pressure (no results, baseline results or reference values were provided) and dizziness, he also presented unstable blood sugar with a fasting blood glucose value of 13 (no units, baseline results or reference values were provided) and a postprandial blood glucose value of 20 (no units, baseline results or reference values were provided); therefore he was hospitalized.In (b)(6) 2014, he was discharged.By (b)(6) 2016, his blood sugar was still higher, fasting blood glucose was 10 to 13 (no units, baseline results or reference values were provided), postprandial blood glucose was 18 to 20 (no units, baseline results or reference values were provided).The button of first humapen ergo ii had problem in (b)(6) 2016 ((b)(4)/lot 1104d02).Button of second humapen ergo ii had problem in (b)(6) 2015 ((b)(4)/lot 1101d02).The corrective treatment and outcome of all the events were not provided.Human insulin 30/70 therapy was continued.The operator of the humapens ergo ii and his/ her training status were not provided.The general duration of use of the first humapen ergo ii and the duration of use of the first suspect humapen ergo ii were six years.The general duration of use of the second humapen ergo ii and the duration of use of the second suspect humapen ergo ii were four years.There was evidence of improper use as the devices were used beyond their self life.The devices were returned no malfunctions were found.The reporting consumer did not provide an assessment of relatedness between the event of cervical vertebra compression and human insulin 30/70.The reporting consumer did not know if the events of blood sugar increased were related to human insulin 30/70 but assessed the remaining events as not related to human insulin 30/70 and related them to the cervical vertebra compression.Edit 07-mar-2016: upon internal review case was unlocked via a non-med sig edit to return the case to the correct priority (back to p1 as the case contains a suspect reusable device with a serious indicator).Update 08-mar-2016: upon review, the case was opened to update the medwatch fields for regulatory reporting; added the product complaints with lot numbers; and updated the narrative.Update 16-mar-2016: additional information received from the initial reporter via a psp on 14-mar-2016.Added the non-serious event of cervical vertebra compression.Updated the relatedness opinion for the serious events of dizziness and high blood pressure.Updated narrative with new information.Update 29mar2016.Additional information received 29mar2016 from the product complaint safety database.To the device tabs entered the date of manufacture, changed improper use to yes, malfunction to no, added the device specific safety summaries (dsss), updated the european and canadian (eu/ca) device information, entered the medwatch device information, and the narrative was updated accordingly.

• 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: 5494771
• MDR Text Key: 40206426
• Report Number: 1819470-2016-00057
• 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: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1104D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2011
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 65