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

Model Number MS9557

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 04/18/2023

Event Type  Injury  

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 77-year-old female patient of unknown origin.Medical history was not provided.Concomitant medications included unspecified 7-8 medication and also there were some unspecified insulin medications used concomitantly, all used for unknown indications.The patient received insulin lispro (rdna origin) injections (humalog) from a cartridge, via a reusable pen, humapen ergo ii, 8-12 international units (iu), thrice daily.Route of administration, indication for use and start date were not provided.Since about (b)(6) 2023, after starting insulin lispro, she noticed that the humapen ergo ii was defective, it started with the her glucose level instability.The device did not work properly, further described as when it was pressed the insulin lispro did not go, the insulin was thought to be gone, but it was not (6456909: unknown, lot number: unknown).According to her husband (husband informed to reporting consumer) she could have gone into a coma, her blood glucose level increased seriously a few times, it has reached unmeasurable situations and had risen to 600s (unit not provided).Event of blood glucose level increased seriously was considered to be serious by the reporter due to medically significant reason.Information regarding corrective treatment and outcome of the events was not provided.Treatment status of insulin lispro was not provided.Follow up was not possible as reporting consumer did not give any consent for himself and the patient's physician to be contacted for follow up.The operator of suspect humapen ergo ii and his/her training status was not provided.The model device duration of use was not provided and suspect device duration of use was about six months.The action taken with suspect device was not provided but it was available for return.The reporting consumer did not provide relatedness assessment between the events and insulin lispro treatment but related the events to suspect humapen ergo ii.Update (b)(6) 2023: upon review of information received on (b)(6) 2023, it was confirmed that the correct name of application pen is humapen ergo ii.No changes were made to the case.Update (b)(6) 2023: upon review, by the affiliate of the information received on (b)(6) 2023, deleted the event of coma since the patient did not experience the same.Updated narrative accordingly.Edit (b)(6) 2023: upon internal reviewof information from (b)(6) 2023, this case was reopened and routed to medical review.No further changes made.Update (b)(6) 2023: additional information received on (b)(6) 2023 from the responsible complaint personnel (rcp) did not include new medically significant information, only included a product complaint (pc) number.No changes were made to the case.Edit (b)(6) 2023: added corresponding pc number wich was processed accordingly.Narrative was amended to include the pc information and details.Upon internal reviewof information received on (b)(6) 2023, amended the information included in the eu/ca device information regarding device distributed in the following countries to reflect the current information available.Edit (b)(6) 2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

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.

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 06jun2023 in the b.5.Field.No further follow-up is planned.Evaluation summary the son of a female patient reported that the patient's humapen ergo ii device "did not work properly.When it was pressed the insulin lispro did not go, the insulin was thought to be gone, but it was not." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number unknown).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.There is no evidence of improper use or storage.

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 77-year-old female patient of unknown origin.Medical history was not provided.Concomitant medications included unspecified 7-8 medication and also there were some unspecified insulin medications used concomitantly, all used for unknown indications.The patient received insulin lispro (rdna origin) injections (humalog) from a cartridge, via a reusable pen, humapen ergo ii, 8-12 international units (iu), thrice daily.Route of administration, indication for use and start date were not provided.Since about (b)(6) 2023, after starting insulin lispro, she noticed that the humapen ergo ii was defective, it started with the her glucose level instability.The device did not work properly, further described as when it was pressed the insulin lispro did not go, the insulin was thought to be gone, but it was not (pc number: (b)(4), lot number: unknown).According to her husband (husband informed to reporting consumer) she could have gone into a coma, her blood glucose level increased seriously a few times, it has reached unmeasurable situations and had risen to 600s (unit not provided).Event of blood glucose level increased seriously was considered to be serious by the reporter due to medically significant reason.Information regarding corrective treatment and outcome of the events was not provided.Treatment status of insulin lispro was not provided.Follow up was not possible as reporting consumer did not give any consent for himself and the patient's physician to be contacted for follow up.The operator of suspect humapen ergo ii and respective training status was not provided.The model device duration of use was not provided and suspect device duration of use was about six months.The action taken with suspect device was not provided but it was available for return.The reporting consumer did not provide relatedness assessment between the events and insulin lispro treatment but related the events to suspect humapen ergo ii.Update 01-may-2023: upon review of information received on 25-apr-2023, it was confirmed that the correct name of application pen is humapen ergo ii.No changes were made to the case.Update 03-may-2023: upon review, by the affiliate of the information received on 25-apr-2023, deleted the event of coma since the patient did not experience the same.Updated narrative accordingly.Edit 04-may-2023: upon internal reviewof information from 25-apr-2023, this case was reopened and routed to medical review.No further changes made.Update 08-may-2023: additional information received on 25-apr-2023 from the responsible complaint personnel (rcp) did not include new medically significant information, only included a product complaint (pc) number.No changes were made to the case.Edit 16-may-2023: added corresponding pc number wich was processed accordingly.Narrative was amended to include the pc information and details.Upon internal reviewof information received on 25-apr-2023, amended the information included in the eu/ca device information regarding device distributed in the following countries to reflect the current information available.Edit 18may2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 06jun2023: additional information received on 31may2023 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields for the suspect humapen ergo ii device 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 IN 46285
• Manufacturer (Section G): ELI LILLY AND COMPANY; lilly corporate center; indianapolis
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174224585
• MDR Report Key: 16953868
• MDR Text Key: 315477970
• Report Number: 1819470-2023-00033
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 77 YR
• Patient Sex: Female