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

Model Number MS9557

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.

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 product complaint (pc), concerned a female patient of unknown age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25, 100 iu/ml) from a cartridge via a reusable humapen ergo ii device, twice a day (morning: 21 u, night: 14 u), subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.She was using the humapen ergo ii device since an unknown date in 2009 (improper use of device).On an unknown dates sometimes the dose-adjusting bolt of the injection pen of humapen ergo ii device needed to be adjusted by three units, and she might adjust to five units by herself.Sometimes the dose of insulin lispro mix 25 was injected too much, and there was one time that she was sent to the hospital because of the hypoglycemia caused by the excessive dose of insulin lispro mix 25 ((b)(4)/lot number 1405d01).Information regarding corrective treatment and outcome of the events was not provided.Status of insulin lispro mix 25 therapy was unknown.No additional follow up would be attempted as the reporter was not willing to receive telephone follow-up and hcp contact details were not provided.The patient was the operator of the reusable humapen ergo ii device and her training status was not provided.The general reusable humapen ergo ii device model duration of use and suspect reusable humapen ergo ii specific device duration of use was unknown but started in 2009 (improper use of the device).The suspect humapen ergo ii device associated with product complaint (b)(4) was returned to the manufacturer on 13apr2020.The initial reporting consumer did not know if the events were related to insulin lispro mix 25 drug.The initial reporting consumer did not provide relatedness assessment between the events and humapen ergo ii device.Update 21apr2020: additional information received on 07apr2020 by consumer reporter and 20apr2020 from global product complaint database was processed together.Recoded the suspect humapen, unknown device to a humapen ergo ii.Updated the lot number from unknown to 1405d01 and the device return status to returned to manufacturer.Added date returned to manufacturer for the humapen ergo ii device associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.Edit 23apr2020: updated medwatch and (b)(6) fields for expedited device reporting.No new information added.

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 product complaint (pc), concerned a female patient of unknown age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75/insulin lispro 25 (rdna origin) (humalog mix 25, 100 iu/ml) from a cartridge via a reusable humapen ergo ii device, twice a day (morning: 21 u, night: 14 u), subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.On an unknown dates sometimes the dose-adjusting bolt of the injection pen of humapen ergo ii device needed to be adjusted by three units, and she might adjust to five units by herself.Sometimes the dose of insulin lispro mix 25 was injected too much, and there was one time that she was sent to the hospital because of the hypoglycemia caused by the excessive dose of insulin lispro mix 25 (pc (b)(4)/lot number 1405d01).Information regarding corrective treatment and outcome of the events was not provided.Status of insulin lispro mix 25 therapy was unknown.No additional follow up would be attempted as the reporter was not willing to receive telephone follow-up and hcp contact details were not provided.The patient was the operator of the reusable humapen ergo ii device and her training status was not provided.The general reusable humapen ergo ii device model duration of use was not provided and the suspect reusable humapen ergo ii specific device duration of use was approximately six years based on the date of manufacture (conflicting information as device was reportedly used starting in 2009)(improper use of the device).The suspect humapen ergo ii device associated with product complaint (b)(4)was returned to the manufacturer on 13apr2020.The initial reporting consumer did not know if the events were related to insulin lispro mix 25 drug.The initial reporting consumer did not provide relatedness assessment between the events and humapen ergo ii device.Update 21apr2020: additional information received on 07apr2020 by consumer reporter and 20apr2020 from global product complaint database was processed together.Recoded the suspect humapen, unknown device to a humapen ergo ii.Updated the lot number from unknown to 1405d01 and the device return status to returned to manufacturer.Added date returned to manufacturer for the humapen ergo ii device associated with product complaint (b)(4).Corresponding fields and narrative updated accordingly.Edit 23apr2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 11jun2020: additional information received on 11jun2020 from the global product complaint database.Entered the device specific safety summary (dsss).Updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to yes (not cirm).Added the date of manufacture for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.Update 12jun2020: additional information received on 12jun2020 from the global product complaint database.No new information was added.

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 11jun2020 in the b.5.Field.No further follow up is planned.Evaluation summary a female patient reported that "sometimes the dose-adjusting bolt of the injection pen of humapen ergo ii device needed to be adjusted by three units, and she might adjust to five units by herself." the patient experienced hypoglycemia.The investigation of the returned device (batch 1405d01, manufactured may 2014) found the device displayed high injection force caused by unknown foreign material on multiple internal components of the device.In addition, the soft touch was debonded and interfered with the dial/injection button rotation, thus not allowing the dial return to zero without increased injection force.Due to the device damage, no further testing could be conducted.Malfunction confirmed.The soft touch damage is consistent with exposure to an unknown chemical while in the field.The foreign material was introduced in the field, not related to the manufacturing process.The core instructions for use describes the proper care and storage of the device and states "do not use alcohol, hydrogen peroxide, bleach, cover in liquid or apply lubrication such as oil, as this could damage the pen.While the patient reportedly used the device since 2009, based on the amount of time elapsed since the device was manufactured (may 2014), the patient may have used the device for a maximum six years.The user manual states 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 foreign material contamination and damage to the device occurred while in the field (not related to the manufacturing process).This may be relevant to the issue of the patient adjusting her dose and event of hypoglycemia.Additionally, the patient likely used the device beyond its approved use life.It is unknown if this is relevant to the event of hypoglycemia.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis
• MDR Report Key: 9992578
• MDR Text Key: 193414534
• Report Number: 1819470-2020-00040
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1405D01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization