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

Model Number MS9557

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 28mar2024 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2024-00014 since there is more than one device implicated.Evaluation summary: a male patient reported that the case for his humapen ergo ii device was broken.He did not report a device malfunction.He experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1903d01, manufactured march 2019) therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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.A complaint history review did not identify any atypical findings with regard to dose accuracy device or case is broken or damaged.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(6) this report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a 65-years-old (at the time of initial report) asian male patient of han nationality.Medical history included complications of diabetes mellitus and hospitalization due to high blood glucose in year 2000.Concomitant medication included insulin glargine used for an unknown indication.The patient received insulin lispro (rdna origin) injection (humalog, 100units/ml) from a cartridge, via a reusable devices humapen unknown device and humapen ergo ii, 14 units each morning, 12 units in the mid-day and 18 units in the evening, three times a day (tid), subcutaneous, for diabetes mellitus, beginning in 2000.He also received human insulin (rdna origin) injection (humulin, 100u/ml) from cartridge via reusable pen humapen ergo ii, 16 units in the morning, noon, and evening, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2003.Approximately since 2003, while on insulin lispro and human insulin therapy, he experienced a high blood glucose and was hospitalized to adjust blood glucose levels ((b)(4), lot unknown) & ((b)(4), lot 1903d01).His pre-prandial blood glucose was 24, his post prandial blood glucose was around 17-18 (units, exact values and reference range was not provided).In 2005, 2006 and 2007 he was subsequently hospitalized each year to adjust his blood glucose.In 2014 or 2015, because of high blood glucose, he was hospitalized and in 2016 or around 2017 (exact details not provided) he was again hospitalized since his blood glucose worsened.This time he received acupuncture treatment, and his dose was insulin lispro was increased to four times a day (qid); in addition to his existing dosage regimen an additional 18 units at nighttime (before bed at 10:00pm) were added to control his glucose overnight.On (b)(6)2023, he experienced issues with one of his humapen ergo ii, that did not work after being pushed down (pc number:(b)(4)/lot number:1908d01).On (b)(6) 2023, the device was returned to manufacturer.Examination of the device components found all were present in the device and correctly oriented.Therefore, the complaint was initially associated with the reportable malfunction of missing drive clutch was not confirmed as this component was present and normal.However, the keys of the anti-back drive (abd) clicker were damaged.This failure mode (damage to the abd clicker) may include loss of abd functionality and inability to properly set a dose.Malfunction confirmed.There was evidence of improper use or storage.The front housing thread damage occurred while in the field (not related to the manufacturing process).As of (b)(6) 2024, his blood glucose was high.Fasting blood glucose in morning was 27 and after meal it was 18 (units and normal range were not provided).His whole body was urticant, his thighs and other body parts were itching terribly all over and were broken by scratching.Further hospitalization details, corrective treatment, discharge date and outcome of rest of the events were not provided.Human insulin and insulin lispro therapy were ongoing.Further follow up was not possible as consent to contact reporter and treating physician was not provided.The operator of the humapen ergo ii and his/her training status was unknown.The device model duration of use and the suspect device duration of use were not reported.The humapen ergo ii was continued and the device was returned to manufacturer for evaluation on 19jun2023.The status of humapen unknown device was not provided and its return was not expected.The status of second humapen ergo ii device was available and the device did not return to manufacturer.The initial reporting consumer did not know if the events reported were related to insulin lispro or human insulin therapy and did not provide any relatedness for the events with suspect humapen devices.Update 28jun2023: additional information received on 20jun2023 from global product complaint database.Updated suspect humapen ergo ii device malfunction from unknown to yes/cirm; updated device returned to manufacturer and return date.Corresponding fields and narrative updated accordingly.Edit 30jun2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 04sep2023: additional information received on 28aug2023 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with (b)(4), lot 1908d01.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to returned to manufacturer.Added date of manufacture for the device and improper use or storage was updated from no to yes and device malfunction type was not considered as cirm.Corresponding fields and narrative updated accordingly.Edit 22nov2023: the case was unlocked to update the corresponding field of device malfunction type as cirm in product tab.No other changes was made to the case.Update 07-mar-2024: additional information was received from the initial reporting consumer on 04-mar-2024.Added details of lab test of blood glucose.Added insulin lispro (humalog u100) as suspect drug and two new suspect devices of humapen unknown device and humapen ergo ii.Added three new episodes of the serious event blood glucose increased with different onset dates and four new non-serious events blood glucose increased (fourth episode), memory impairment, scratch, and itching.Deleted the event of blood glucose abnormal upon confirmation of onset of blood glucose increased.Added relevant details of suspect drug and devices, eu/ca fields and updated causality statement and narrative with new information.Update 28mar2024: additional information received on 25mar2024 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information.Improper use or storage was updated from yes to no for humapen unknown device associated with (b)(4) and humapen ergo ii associated with (b)(4).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 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis, IN 46285 ; 3174332191
• MDR Report Key: 19016800
• MDR Text Key: 339083417
• Report Number: 1819470-2024-00013
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1903D01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian