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

Model Number MS9557

Device Problems Fluid/Blood Leak (1250); Inaccurate Delivery (2339)

Patient Problems High Blood Pressure/ Hypertension (1908); Diabetic Ketoacidosis (2364)

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 report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned an asian female patient of unknown age.Medical history included heart disease, hypertension, cervical spondylosis, cerebral infarction, high blood lipids, and other 14 unknown diseases.Drug adverse reaction history, family drug reaction concomitant medications were not reported.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25 100 u) from a cartridge via a reusable pen (humapen ergo ii)12 units three times daily, divided in 4 each morning, 4 at noon and 4 each evening subcutaneously for the treatment of diabetes mellitus beginning in (b)(6) 2015.Around (b)(6) 2016, patient bought humapen ergo ii and she found that when injection, there was leakage on the needles, after injection of insulin; there were lot of liquid on needles.She doubted if insulin was not injected into body.(lot 1506d02, pc 3634855).From (b)(6) 2016 she was hospitalized due to heart disease, high blood pressure and diabetes in the hospital.From (b)(6) 2016, patient was hospitalized again due to heart disease, high blood pressure and diabetes.Information regarding corrective treatments and outcome of the events were not provided.Insulin lispro protamine suspension 75%/ insulin lispro 25% was continued.The user of the humapen ergo ii and his/her training status was not provided.The humapen ergo ii model duration of use was not provided but started since (b)(6) 2016.If device is returned, evaluation will be performed.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% and did not provide a relatedness assessment for humapen ergo ii.Update 26apr2016: upon review, this case was opened to update the medwatch and complete the european and canadian required device reporting elements for regulatory reporting.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements.No further follow up is planned.Evaluation summary: a consumer reported on behalf of the patient the humapen ergo ii device leaked from the needle after the injection.The patient suspected the insulin was not injected; she was hospitalized for diabetes.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured june 2015).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 leaking after injection or dose accuracy.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, which ensures dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned an asian female patient of unknown age.Medical history included heart disease, hypertension, cervical spondylosis, cerebral infarction, high blood lipids, and other 14 unknown diseases.Drug adverse reaction history, family drug reaction concomitant medications were not reported.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25 100 u) from a cartridge via a reusable pen (humapen ergo ii)12 units three times daily, divided in 4 each morning, 4 at noon and 4 each evening subcutaneously for the treatment of diabetes mellitus beginning in (b)(6) 2015.Around (b)(6) 2016, patient bought humapen ergo ii and she found that when injection, there was leakage on the needles, after injection of insulin; there were lot of liquid on needles.She doubted if insulin was not injected into body.(lot 1506d02, pc 3634855).From (b)(6) 2016 she was hospitalized due to heart disease, high blood pressure and diabetes in the hospital.From (b)(6) 2016, patient was hospitalized again due to heart disease, high blood pressure and diabetes.Information regarding corrective treatments and outcome of the events were not provided.Insulin lispro protamine suspension 75%/ insulin lispro 25% was continued.The user of the humapen ergo ii and his/her training status was not provided.The humapen ergo ii model duration of use was not provided but started since (b)(6) 2016.The device was not returned.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% and did not provide a relatedness assessment for humapen ergo ii.Update 26-apr-2016: upon review, this case was opened to update the medwatch and complete the european and canadian required device reporting elements for regulatory reporting.Edit 18-may-2016: (b)(4) were received on (b)(6) 2016 and processed on (b)(6) 2016.No changed were done to the case.Update 24may2016: additional information received on 23may2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; 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: 5620311
• MDR Text Key: 44119648
• Report Number: 1819470-2016-00105
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1506D02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2015
• 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 Weight: 50