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

Model Number MS9557

Device Problems Material Too Rigid or Stiff (1544); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Physical Resistance/Sticking (4012)

Patient Problem Hyperglycemia (1905)

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 solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6)-year-old female patient of an unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from a cartridge via a reusable device humapen ergo ii, at an unknown dose and frequency subcutaneously for the treatment of diabetes beginning on an unknown date before 2006.She started humapen ergo ii approximately in 2006 or 2011 (which was considered as improper use).On an unspecified date, (reported as few months from initial receipt date (b)(6) 2021) while taking human insulin isophane suspension 70%/human insulin 30% treatment, her humapen ergo ii was impaired and became heavy while pressing on the injection button to release the dose.Because of this, sometimes she was not sure whether she took accurate dose or not; which made her high blood glucose that reached 500s mg/dl (reference range not provided) (pc unknown, lot 1110d03).She was admitted to the hospital to normalize her blood glucose level before cataract surgery.In addition, she had weak eyesight, and cataract for which she underwent cataract surgery sometime in 2011 or 2013.Information regarding further hospitalization details and corrective treatment for remaining events was not provided.Outcome of the events was not resolved.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The operator of the humapen ergo ii device was unknown and his/her training status was not provided.The general model humapen ergo ii device duration of use was not provided and the suspect humapen ergo ii duration of use was approximately fifteen years as it was started approximately in 2006 or 2011.The action taken with humapen ergo ii was not provided and its return status was expected.The reporting consumer did not relate the events high blood glucose and incorrect dose administered and did not provide any opinion on relatedness assessment between the remaining event and human insulin isophane suspension 70%/human insulin 30% drug.The reporting consumer related the events high blood glucose and incorrect dose administered and did not provide any opinion on relatedness assessment for the remaining event with humapen ergo ii device.Edit 04mar2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.

Event Description

(b)(6).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 73-year-old female patient of an unknown origin.Medical history and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100 u/ml) from a cartridge via a reusable device humapen ergo ii, at an unknown dose and frequency subcutaneously for the treatment of diabetes beginning on an unknown date before 2006.She started humapen ergo ii approximately in 2006 or 2011 (which was considered as improper use).On an unspecified date, (reported as few months from initial receipt date (b)(6) 2021) while taking human insulin isophane suspension 70%/human insulin 30% treatment, her humapen ergo ii was impaired and became heavy while pressing on the injection button to release the dose.Because of this, sometimes she was not sure whether she took accurate dose or not; which made her high blood glucose that reached 500s mg/dl (reference range not provided) (pc unknown, lot 1110d03).She was admitted to the hospital to normalize her blood glucose level before cataract surgery.In addition, she had weak eyesight, and cataract for which she underwent cataract surgery sometime in 2011 or 2013.Information regarding further hospitalization details and corrective treatment for remaining events was not provided.Outcome of the events was not resolved.Human insulin isophane suspension 70%/human insulin 30% treatment was continued.The operator of the humapen ergo ii device was unknown and his/her training status was not provided.The general model humapen ergo ii device duration of use was not provided and the suspect humapen ergo ii duration of use was approximately fifteen years as it was started approximately in 2006 or 2011.The action taken with humapen ergo ii was not provided and it was not returned to the manufacturer.The reporting consumer did not relate the events high blood glucose and incorrect dose administered and did not provide any opinion on relatedness assessment between the remaining event and human insulin isophane suspension 70%/human insulin 30% drug.The reporting consumer related the events high blood glucose and incorrect dose administered and did not provide any opinion on relatedness assessment for the remaining event with humapen ergo ii device.Edit 04mar2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 02apr2021: additional information received on 26mar2021 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields.Added the date of manufacture for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field; new updated and corrected information is referenced within the update statements in b.5.Please refer to statement dated (b)(6) 2021 in the b.5.Field.No further follow up is planned.Evaluation summary a female patient reported that her humapen ergo ii was impaired for a few months and became heavy while pressing on the injection button to release the dose.Because of this, sometimes she was not sure whether she took an accurate dose or not.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1110d03, manufactured october 2011).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review and a batch trend review did not identify any atypical findings with regard to injection force high or 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.The patient reported that she had used the device since 2011.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.In addition, the patient continued to use the device after experiencing the complaint issue.The core instructions for use state if any of the parts of your humapen ergo ii appear broken or damaged, do not use.The core instructions for use also states to always carry a spare insulin pen in case your pen is lost or damaged.The patient also reported visual impairment.The core instructions for use state that the device is not recommended for the visually impaired without the assistance of a sighted individual trained to use it.There is evidence of improper use.The patient used the device beyond its recommended use period and continued to use the device after experiencing the alleged complaint issue.These misuses may be relevant to the event of increased blood glucose.The patient used the device while visually impaired.It is unknown if this misuse is relevant to the complaint or the event of increased blood glucose.

• 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: 11562868
• MDR Text Key: 258893365
• Report Number: 1819470-2021-00040
• 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: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1110D03
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR