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

Model Number MS9557

Device Problems Difficult to Insert (1316); Fitting Problem (2183); Activation, Positioning or Separation Problem (2906)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a (b)(6) female patient of an unknown origin.Medical history included heart disease, diabetes, blood pressure disease (unspecified), vascular occlusion and blood sugar thinned the vessels.Concomitant medications included unspecified drug for the treatment of heart, diabetes and blood pressure and blood thinner medicine.The patient received human insulin (rdna origin) (humulin r) from a cartridge via a reusable device (humapen ergo ii), eight international units each morning, 10 international units at noon and 10 international units each evening, three times a day (tid), via unknown route, for the treatment of diabetes, beginning on (b)(6) 2021.Approximately since (b)(6) 2021, 33 days after starting human insulin therapy, she experienced trouble using humapen ergo ii.She used one needle but could not insert the second one.After inserting the cartridge into the pen, there was a problem where the cartridge was fixed, and it did not fit inside ((b)(4), lot 1807d04).Her blood sugar went up and down constantly (values, units and reference range not provided).She used another insulin drug at night but experienced some weakness and sugar spikes during the day because human insulin was not applied.Her blood sugar normally was very high 700-800 or 300-400-500s (units and reference range not provided).On an unspecified date, she was planned to have a surgery for her pre-existing condition of vascular occlusion.She needed an open heart surgery as the stent could not be inserted because blood sugar thinned the vessels and she needed to have her sugar controlled.Her blood sugar dropped since starting human insulin.On (b)(6) 2021, night her blood sugar was 162 (units and reference range not provided).Information regarding corrective treatment, outcome of the events and status of human insulin therapy was not provided.Follow up was not possible as consent to contact reporter and treating physician contact details were not provided.The operator of humapen ergo ii was the patient and her training status was not provided.The general and suspect humapen ergo ii device duration of use was approximately 33 days.The action taken with suspect humapen ergo ii device and its return was not provided.The reporting consumer did not provide if the events reported were related to human insulin drug however considered the events as related to the suspect humapen ergo ii device.Update 10-dec-2021: additional information provided by local affiliate on 08-dec-2021.Device batch number was provided and added in database.Narrative was updated accordingly.Update 14dec2021: additional information received on 08dec2021 from global product complaint database reiterated the lot number 1807d04 which was already present and correct in the case.Deleted lot number reason.

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), concerns a 56-years-old female patient of an unknown origin.Medical history included heart disease, diabetes, blood pressure disease (unspecified), vascular occlusion and blood sugar thinned the vessels.Concomitant medications included unspecified drug for the treatment of heart, diabetes and blood pressure and blood thinner medicine.The patient received human insulin (rdna origin) (humulin r) from a cartridge via a reusable device (humapen ergo ii), eight international units each morning, 10 international units at noon and 10 international units each evening, three times a day (tid), via unknown route, for the treatment of diabetes, beginning on (b)(6) 2021.Approximately since (b)(6) 2021, 33 days after starting human insulin therapy, she experienced trouble using humapen ergo ii.She used one needle but could not insert the second one.After inserting the cartridge into the pen, there was a problem where the cartridge was fixed, and it did not fit inside (pc (b)(4), lot 1807d04).Her blood sugar went up and down constantly (values, units and reference range not provided).She used another insulin drug at night but experienced some weakness and sugar spikes during the day because human insulin was not applied.Her blood sugar normally was very high 700-800 or 300-400-500s (units and reference range not provided).On an unspecified date, she was planned to have a surgery for her pre-existing condition of vascular occlusion.She needed an open heart surgery as the stent could not be inserted because blood sugar thinned the vessels and she needed to have her sugar controlled.Her blood sugar dropped since starting human insulin.On (b)(6) 2021, night her blood sugar was 162 (units and reference range not provided).Information regarding corrective treatment, outcome of the events and status of human insulin therapy was not provided.Follow up was not possible as consent to contact reporter and treating physician contact details were not provided.The operator of huma pen ergo ii was the patient and her training status was not provided.The general and suspect humapen ergo ii device duration of use was approximately 33 days.The suspect humapen ergo ii device returned to manufacturer.The reporting consumer did not provide if the events reported were related to human insulin drug however considered the events as related to the suspect humapen ergo ii device.Update 10-dec-2021: additional information provided by local affiliate on 08-dec-2021.Device batch number was provided and added in database.Narrative was updated accordingly.Update 14dec2021: additional information received on 08dec2021 from global product complaint database reiterated the lot number 1807d04 which was already present and correct in the case.Deleted lot number reason.Update 26jan2022: additional information received on 21jan2022 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, and device return status to returned to manufacturer; and added date of manufacture and date returned to manufacturer for the suspect device associated with pc (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 update statement(s) dated 26jan2022 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported she experienced trouble using her humapen ergo ii.She successfully used one needle but could not attach the second needle to the pen.She experienced increased blood glucose.The device (batch 1807d04, manufactured july 2018) was returned to the manufacturer without the cartridge holder.Testing of the device using a designated cartridge holder found the device met functional requirements and met dose accuracy and glide (injection) force specifications.Since the cartridge holder was not returned, it could not be evaluated to investigate the needle attachment issue; however, the patient initially experienced no issue with needle attachment.Malfunction unknown.There is no evidence of improper use or storage.

• 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): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 13014168
• MDR Text Key: 284113155
• Report Number: 1819470-2021-00170
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: 1807D04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2018
• 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: 56 YR
• Patient Sex: Female