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

Model Number MS9557

Device Problem Mechanical Problem (1384)

Patient Problems Bone Fracture(s) (1870); Hyperglycemia (1905); Impaired Healing (2378)

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

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a male patient of an unknown age and origin.Medical history was not provided.Concomitant medications included insulin glargine for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog, 100 u/ml) from a cartridge via a reusable device humapen ergo ii, 25, 26, 28 units twice a day while eating the meal, subcutaneously for the treatment of diabetes mellitus beginning approximately in 2010.He started humapen ergo ii approximately in 2010.On an unknown date while insulin lispro treatment taking he had diabetes mellitus consequences and had slow wound healing and bone fracture (cataclasis) for which he was hospitalized for two months.Also, sometimes the blood glucose was high (values, units and reference range not provided), therefore dose of insulin lispro was increased 31 or 32 once in the morning, at noon and night respectively three times day.Sometime in 2019, the humapen ergo ii pen does not had clicking sound when it was pressed one time until the end which was not controlled and sometimes only clicked one or two sound was heard when injection button was pressed down until the end due to humapen ergo ii issue (pc#: (b)(4); lot#: 0910d02).He used humapen ergo ii for ten year which was considered as improper use.Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided.Insulin lispro treatment was continued.No additional follow-up would be attempted as the reporter refused to be followed up via phone and no physician contact information was provided.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 and the suspect humapen ergo ii duration of use was approximately ten years as it was started approximately in 2010.The patient continued to use the humapen ergo ii and its return status was not reported.The reporting consumer did not provide any opinion on relatedness assessment between the events and insulin lispro drug or with humapen ergo ii device.Update 25-aug-2020: initial information received on (b)(6) 2020 and follow up information received on 21-aug-2020 was processed together.Edit 28aug2020: updated medwatch and (b)(6) fields for expedited device reporting.No new information added.

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 adverse events and a product complaint (pc), concerned a male patient of an unknown age and origin.Medical history was not provided.Concomitant medications included insulin glargine for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog, 100 u/ml) from a cartridge via a reusable device humapen ergo ii, 25, 26, 28 units twice a day while eating the meal, subcutaneously for the treatment of diabetes mellitus beginning approximately in 2010.He started humapen ergo ii approximately in 2010.On an unknown date while insulin lispro treatment taking he had diabetes mellitus consequences and had slow wound healing and bone fracture (cataclasis) for which he was hospitalized for two months.Also, sometimes the blood glucose was high (values, units and reference range not provided), therefore dose of insulin lispro was increased 31 or 32 once in the morning, at noon and night respectively three times day.Sometime in 2019, the humapen ergo ii pen does not had clicking sound when it was pressed one time until the end which was not controlled and sometimes only clicked one or two sound was heard when injection button was pressed down until the end due to humapen ergo ii issue (pc number (b)(4); lot number 0910d02).He used humapen ergo ii for ten year which was considered as improper use.Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided.Insulin lispro treatment was continued.No additional follow-up would be attempted as the reporter refused to be followed up via phone and no physician contact information was provided.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 and the suspect humapen ergo ii duration of use was approximately ten years as it was started approximately in 2010.The patient continued to use the device.The humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not provide any opinion on relatedness assessment between the events and insulin lispro drug or with humapen ergo ii device.Update (b)(6) 2020: initial information received on (b)(6) 2020 and follow up information received on (b)(6) 2020 was processed together.Edit (b)(6) 2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update (b)(6) 2020: additional information received on (b)(6)2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information for the humapen ergo ii device associated with product complaint (b)(4) which was not was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.Edit (b)(6) 2020: updated medwatch fields for expedited device reporting and added contact log according.No new information added.

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 (b)(6) 2020 in the b.5.Field.No further followup is planned.Evaluation summary: a male patient's family reported that sometime in 2019, patient's humapen ergo ii device "does not had clicking sound when it was pressed one time until the end which was not controlled and sometimes only clicked one or two sound was heard when injection button was pressed down until the end." the patient experienced inadequate control of diabetes mellitus.The device was not returned to the manufacturer for investigation (batch 0910d02, manufactured (b)(6) 2009).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.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 reported the device was used since 2010 (10 years).The core instructions for use states the humapen ergo ii has been designed to be used for up to three years after first use.In addition, the patient reportedly continued to use the device.The core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use.There is evidence of improper use.The patient used the device beyond its approved use life and continued to use the device after experiencing the alleged complaint issue.It is unknown if these use issues are relevant to the event of inadequate control of diabetes mellitus.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 10476461
• MDR Text Key: 210162842
• Report Number: 1819470-2020-00113
• 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,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 0910D02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization