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 Cataract (1766); Glaucoma (1875); Retinal Degeneration (2049); Loss of Vision (2139)

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements in describe event or problem.No further follow-up is planned.A male patient reported that his humapen ergo ii device malfunctioned, but after priming could then be used normally.The patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch number 1312d01, manufactured december 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to dose accuracy issues.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 or storage.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) (at the time of the initial report) asian male patient.Medical history included hemiplegia.Concomitant medications calcium hydroxybenzoate and ginaton (as reported), both used for unknown indication.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from cartridge via a reusable device (humapen ergo 2), subcutaneously for the treatment of diabetes mellitus beginning approximately on an unknown date in 2013 or 2014 (conflicting information provided).On an unknown date, after starting of human insulin isophane suspension 70%/human insulin 30% therapy, he subsequently had diabetic macular degeneration, acute glaucoma, slight cataract in both eyes, blindness in the right eye and had a little vision in his left eye.The events of macular degeneration, angle closure glaucoma and blindness were considered as serious due to medically significant reason.On an unknown his blood glucose was not regulated (values and reference range were not reported).Approximately in 2015 or 2016 (conflicting information provided), he was admitted into the hospital to regulate his blood glucose.While he was in the hospital, his physician advised to change into insulin lispro protamine suspension 50%/insulin lispro 50%, 14 or 15 units (conflicting information provided) and on an unknown date the dose was changed to 18 units in the morning and 18 units in night and as on (b)(6) 2018 it was continued.Information regarding hospitalization dates, lab examination findings, corrective treatment and outcome of the events was not reported.It was unknown if human insulin isophane suspension 70%/human insulin 30%, therapy would be restarted.The operator of the humapen ergo 2 and his/her training status were not provided.The general humapen ergo 2 model duration of use was not provided but it started approximately in 2013 or 2014 (conflicting information provided).The humapen ergo 2 was still in use.If humapen ergo 2 was returned, evaluation would be performed to determine if a malfunction had occurred.The reporting consumer was not sure for relatedness of the events with human insulin isophane suspension 70%/human insulin 30% treatment, did not provide relatedness with the humapen ergo 2.Edit 22mar2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 11apr2018: additional information received on 11apr2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated with lot 1312d01 of humapen ergo ii device.Corresponding fields and narrative 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 7426645
• MDR Text Key: 105935200
• Report Number: 1819470-2018-00045
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1312D01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 70