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 Problem Missed Dose (2561)

Event Type  Injury  

Manufacturer Narrative

Description of problem or event: narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement(s) dated 29jul2019.No further follow-up is planned.This is a downgrade report, which no longer meets the criteria for expedited reporting.Evaluation summary a patient reported that the injection button of their humapen ergo ii device could not be pushed down and the displayed units did not return to zero.The patient experienced increased blood glucose.The device was not returned for investigation (batch 1810d05, manufactured october 2018).With the guidance of a trained professional; the patient changed the needle and primed the pen, and the issue was resolved.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report a product complaint (pc) and adverse events, concerned a patient of unknown age, gender and ethnicity.Medical history included hospitalizations and historical medications included ganshulin insulin (as reported).Concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog series, 100 u/ml) from cartridge via a reusable device humapen ergo ii (blue, plastic) at an unknown dose, frequency and route for the treatment of diabetes mellitus beginning in (b)(6) after hospitalization.On an unknown date, while taking insulin lispro treatment, the patient blood glucose controlled was not good all time and blood glucose values was high more than 30 (units and reference range were not provided) due to which patient was hospitalized sometime in (b)(6) and at same time on (b)(6) 2019 or (b)(6) 2019.The patient did not injected insulin lispro due to the humapen ergo ii malfunction and injection button of humapen ergo ii could not be pushed down and the displayed units did not return to zero (pc: (b)(4); lot number: 1810d05).Blood glucose would first regulated and after the blood glucose was stable patient would undergo minimally invasive lung surgery (specific condition and reason was not provided).Further also felt sick and brain was not clear or good.Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided.Insulin lispro treatment was ongoing.The operator of the humapen ergo ii was unknown and his/her training status was not provided.The general model humapen ergo ii duration of use was not provided however it was started approximately two months (started in (b)(6) 2019).The suspect device, which was manufactured in oct2018, was not returned to the manufacturer as under the guidance of a trained professional the issue was resolved.The reporting consumer did not provide any opinion on relatedness assessment between the events and insulin lispro treatment.The reporting consumer considered the event of missed dose as related to the humapen ergo ii and did not provide an assessment of relatedness between remaining events and the humapen ergo ii.Edit 23-jul-2019: on review updated seriousness criteria of hospitalization in narrative.Edit 23jul2019: updated medwatch fields for expedited device reporting.No new information added.Update 29jul2019: additional information received on (b)(4) 2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and (b)(4) (eu/(b)(4)) device information, malfunction from unknown to no, and device return status to not returned to manufacturer.Added date of manufacturer for pc (b)(4) associated with lot 1810d05 of humapen ergo ii device.Corresponding fields and narrative updated accordingly.Update 06aug2019: additional information received on (b)(4) 2019 from the global product complaint database.No new information was added.

• 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8875732
• MDR Text Key: 154015713
• Report Number: 1819470-2019-00141
• 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
• Report Date: 08/08/2019

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?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1810D05
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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