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

Model Number MS9557

Device Problems Fracture (1260); Failure to Deliver (2338); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hyperglycemia (1905)

Event Date 12/01/2020

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: tr202012000824 this report is associated with product complaint: 5390559 this solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) patient of unknown origin.Medical history was not provided.Concomitant medication included insulin aspart/insulin aspart protamine for unknown indication.The patient received human insulin (rdna origin) regular (humulin regular) from cartridge via reusable pen device (humapen ergo ii) for the treatment of unknown indication beginning on an unknown date.Dosage regimen was not provided.On an unknown date after starting human insulin therapy, there were issues with the reusable device and it would not inject medication (batch lot number: unknown, pc:5390559).On 01-dec-2020, her blood glucose was elevated to 600 (no units, values and ranges were provided).Outcome for the event and information regarding the corrective treatment was unknown.Human insulin therapy was unknown.The patient was the operator of the humapen ergo ii device and her training status was unknown.The general model device duration of use was unknown.The suspect device duration of use for humapen ergo ii was about three years.The suspect device status was unknown and if the device was returned, evaluation would be performed.The reporting consumer did not provide the relatedness between the events and human insulin treatment or with the humapen ergo ii device.The event of missed dose was due to the issue with the humapen ergo ii device.Edit 09dec2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

Manufacturer Narrative

No further follow-up is planned.Evaluation summary.The daughter of a female patient reported that the patient's humapen ergo ii "stick was broken in the pen." she stated that the "pen didn't give drug and the stick was broken due to forcing." the "stick" is interpreted as the injection screw.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1703d02, manufactured march 2017).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.However, based on the complaint description, the damage to the device occurred in the field (not related to the manufacturing process) due to application of excessive force.A complaint history review and trend review for the batch did not identify any atypical findings with regard to device not working issues.A complaint history review for the batch did not identify any atypical findings with regard to broken injection screw issues.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The core instructions for use states 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.There is evidence of improper use.The reporter indicated that force was applied to the device causing the breakage and inability to deliver the dose.This use issue may be relevant to the event of increased blood glucose.

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 57-year-old female patient of unknown origin.Medical history was not provided.Concomitant medication included insulin aspart/insulin aspart protamine for unknown indication.The patient received human insulin (rdna origin) regular (humulin regular) from cartridge via reusable pen device (humapen ergo ii) for the treatment of unknown indication beginning on an unknown date.Dosage regimen was not provided.On an unknown date after starting human insulin therapy, there were issues with the reusable device and it would not inject medication (batch lot number: 1703d02, pc:(b)(4)).On (b)(6) 2020, her blood glucose was elevated to 600 (no units, values and ranges were provided).Outcome for the event and information regarding the corrective treatment was unknown.Human insulin therapy was unknown.The patient was the operator of the humapen ergo ii device and her training status was unknown.The general model device duration of use was unknown.The suspect device duration of use for humapen ergo ii was about three years.The suspect device, which was manufactured in mar2017, status was unknown and was not returned to the manufacturer.The reporting consumer did not provide the relatedness between the events and human insulin treatment or with the humapen ergo ii device.The event of missed dose was due to the issue with the humapen ergo ii device.Edit 09dec2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 03feb2021: additional information received on 03feb2021 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 and storage from no to yes, and device return status to not returned to manufacturer.Added date of manufacturer for pc (b)(4) associated with lot 1703d02 of humapen ergo ii device.Upon review, updated lot from unknown to 1703d02 associated with pc (b)(4) 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
• MDR Report Key: 11003508
• MDR Text Key: 221294501
• Report Number: 1819470-2020-00170
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1703D02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR