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); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Description of problem or event: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 10jun2019.No further follow-up is planned.Evaluation summary a patient reported that their humapen ergo ii device "was pushed to the end with clicking sound" when injecting.The patient experienced increased blood glucose.The device was not returned for investigation (batch 0712d04, manufactured december 2007).The pen was checked by a diabetes educator; the issue was solved, and the pen was working normally.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.The patient used the device since 2008.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.This is not likely relevant to the event since the device was found to be working normally.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous device case, reported by a consumer who contacted the company, to report adverse events with a product complaint (pc), concerned a (b)(6) female patient.Medical history included being allergic to sulfonamides.Concomitant medications were not reported.The patient received insulin glargine (unknown manufacturer) and human insulin isophane suspension (uslin) via a humapen ergo ii (blue) pen, beginning in 2008.Dosage regimen, route of administration and indication for use were not provided.On an unknown date, after starting insulin glargine and human insulin isophane suspension via a humapen ergo ii, his blood glucose was increased (value, units and reference range were not provided) ((b)(4); lot no 0712d04).He was hospitalized on an unknown date due to the event.He also had copper acidosis.Further information regarding hospitalization, corrective treatment, outcome of the events and status of insulin glargine and human insulin isophane suspension (unknown manufacturers) treatments was not provided.Status of humapen ergo ii was continued.The operator of the humapen ergo ii and his/her training status was not provided.The model duration of use and suspect duration for humapen ergo ii were not reported but was started in 2008.The status of humapen ergo ii was continued and its return status was not provided.The initial reporting consumer did not provide an opinion of relatedness between the events and insulin glargine or human insulin isophane suspension (unknown manufacturers) treatments.The initial reporting consumer did not know if the event of blood glucose was related and did not associate remaining update 24-may-2019: information received form the initial reporter on 15-may-2019, did not contain any significant information.Product complaint was received.No other change was made in the case.Edit 29may2018: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Update 10jun2019: additional information received on 07jun2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and (b)(4) (eu/(b)(4)) device information, and malfunction from unknown to no.Added date of manufacturer for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Upon review, added suspect device age field accordingly and updated gender from female to male in 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8700323
• MDR Text Key: 148178314
• Report Number: 1819470-2019-00104
• 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
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0712D04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2007
• 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: 53 YR
• Patient Weight: 53