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

Model Number MS9557

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

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, concerned an (b)(6) female patient.Medical history was not provided.Concomitant medications included lacidipine for the treatment of hypertension.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) cartridge via reusable pen (humapen ergo ii), 14 each morning and 14 at night, bid (units were not provided), subcutaneously for the treatment of diabetes, beginning in 2012 or 2013.On an unspecified date, after starting insulin lispro 75/25 treatment, she experienced diabetes complications such as hypertension, coronary heart disease (considered serious for medical significance) and other unspecified diseases.Sometime while taking insulin lispro 75/25, she ate high sugar foods and she would add one unit of her dose by medical prescription for unknown reasons.On (b)(6) 2016, she was hospitalized due to diabetes to regulate blood sugar.On (b)(6) 2016, there was an unspecified product complaint reported for the humapen ergo ii (product complaint pending/ lot 1311d02).Further details about hospitalization were not provided.Information regarding corrective treatment and outcome of the events were unknown.Insulin lispro 75/25 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 and the suspect humapen ergo ii duration of use were not provided.The action taken with the suspect humapen ergo ii was not provided and its return was not expected.The reporting consumer did not know if the events were related to insulin lispro 75/25 and did not provide an assessment of relatedness between the events and humapen ergo ii.The reporter refused to be contacted and did not give permission to contact the treating physician.Update 22sep2016: upon review, this case was opened to update the medwatch fields for regulatory reporting, and to add the product complaint information to the narrative.

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements in describe event or problem.Please refer to update statement dated 26oct2016 in the describe event or problem.No further follow up is planned.Evaluation summary a female patient reported that the injection button on her humapen ergo ii was difficult to press down.A few days prior to this complaint, the patient was hospitalized to regulate her blood sugar (abnormal blood sugar).The device was not returned to the manufacturer for investigation ((b)(4), manufactured november 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.Based on the timeline of when the abnormal blood glucose event and injection button problem occurred, the complaint may or may not be related to the adverse event.A complaint history review of the batch did not identify any atypical trends with regard to dose accuracy.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.The patient reused needles.Needle reuse may be relevant to the event of abnormal blood sugar.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned an (b)(6) female patient.Medical history was not provided.Concomitant medications included lacidipine for the treatment of hypertension.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) (humalog mix25) cartridge via reusable pen (humapen ergo ii), 14 each morning and 14 at night, bid (units were not provided), subcutaneously for the treatment of diabetes, beginning in 2012 or 2013.On an unspecified date, after starting insulin lispro 75/25 treatment, she experienced diabetes complications such as hypertension, coronary heart disease (considered serious for medical significance) and other unspecified diseases.Sometime while taking insulin lispro 75/25, she ate high sugar foods and she would add one unit of her dose by medical prescription for unknown reasons.On (b)(6) 2016, she was hospitalized due to diabetes to regulate blood sugar.On 18sep2016, there was an unspecified product complaint reported for the humapen ergo ii ((b)(4)/ lot 1311d02).Further details about hospitalization were not provided.Information regarding corrective treatment and outcome of the events were unknown.Insulin lispro 75/25 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 and the suspect humapen ergo ii duration of use were not provided.The device was not returned.The reporting consumer did not know if the events were related to insulin lispro 75/25 and did not provide an assessment of relatedness between the events and humapen ergo ii.The reporter refused to be contacted and did not give permission to contact the treating physician.Update 22sep2016: upon review, this case was opened to update the medwatch fields for regulatory reporting, and to add the product complaint information to the narrative.Update 19-oct-2016: additional information received on 19-sep-2016 from local affiliate with pc number.Pc was processed and narrative updated accordingly.Update 26-oct-2016: additional information received on 25-oct-2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; updated the improper use and storage to yes; added that 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: 6012167
• MDR Text Key: 57360272
• Report Number: 1819470-2016-00256
• 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: 09/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1311D02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2013
• 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 LISPRO; LACIDIPINE
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Weight: 55