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

Model Number MS9557

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 05/31/2022

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 12-year-old female patient of an unknown origin.Medical history included urinary tract infection and diabetes mellitus.Concomitant medications included benfotiamine/cyanocobalamin/pyridoxine hydrochloride and insulin glargine, both for diabetes mellitus and cholecalciferol for vitamins deficiency.The patient received insulin lispro (rdna origin) injection (humalog) from a cartridge via a reusable pen (humapen ergo ii), 13 units daily, via unknown route, for diabetes mellitus, beginning on an unknown date in 2016.Start date of humapen ergo ii was unknown.On an unknown date, she suffered from hyperglycemia sometimes if she did not administer the medications.On an unknown date in (b)(6) 2022, while on insulin lispro therapy, she suffered from numbing all over the body before and during the hyperglycemia and had vomiting due to which she was hospitalized.The health care professional gave her certain doses of insulin lispro and then she was taking 10 units in the morning, 12 units in afternoon and 18 units in the evening of the insulin lispro therapy.She then suffered from urinary tract infection that according to the physician affected the blood glucose level to be 400 to 500 (units not provided) and acetone to 3 (units and reference ranges were not provided) and after the recovery from the urinary tract infection the physician decreased the daily units of insulin lispro to 13 units per day.The event of hypoglycemia was considered as serious by the company due to medically significant reason.On an unknown date in (b)(6) 2022, the cartridge got empty fast as the nearest cartridge used was on (b)(6) 2022 and it got empty on (b)(6) 2022 although the units that she administered was not supposed to empty the cartridge in such duration as she was taking 6 units in morning and 6 units in afternoon and 01 unit at evening and sometimes she might correct the blood glucose level with 2 units.After she administered the insulin lispro dose with humapen ergo ii, she suffered from hypoglycemia as the blood glucose range from 30 to 80 postprandial so she tried to administer the insulin lispro with insulin needle and did not suffer from hypoglycemia.It was thought that the humapen ergo ii was the problem (pc no 6048812 and lot no 1709d02) as it was giving more insulin doses than adjusted which caused hypoglycemia.The outcome of events hypoglycemia, hyperglycemia (both episodes), body numbness and urinary tract infection were resolved, and outcome of remaining events was unknown.Corrective treatment details were not provided.Status of insulin lispro therapy was continued.The operator of the humapen ergo ii was unknown and his/her training status was not provided.The device model and the suspect humapen ergo ii duration of use was not provided.The action taken with the humapen ergo ii was unknown and its return was expected.The initial reporting consumer related the event of hypoglycemia with insulin lispro therapy and with humapen ergo ii.The initial reporting consumer did not relate the events of hyperglycemia (serious event), body numbness and urinary tract infection with insulin lispro therapy and with humapen ergo ii while did not provide the relatedness of remaining events with lispro therapy and with humapen ergo ii.Edit (b)(6) 2022: updated medwatch fields for expedited device reporting.No new information added.

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 dated 01sep2022 in the b.5.Field.Evaluation summary: a caregiver reported the patient's humapen ergo ii was delivering "more doses than adjusted" because the cartridge emptied fast.The patient experienced hypoglycemia.The device was not returned to the manufacturer for investigation (batch 1709d02, manufactured september 2017).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review and batch threshold review did not identify any atypical findings with regards to alleged overdose or dose accuracy issues.This is the first overdose complaint received for this batch.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.

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 12-year-old female patient of an unknown origin.Medical history included urinary tract infection and diabetes mellitus.Concomitant medications included benfotiamine/cyanocobalamin/pyridoxine hydrochloride and insulin glargine, both for diabetes mellitus and cholecalciferol for vitamins deficiency.The patient received insulin lispro (rdna origin) injection (humalog) from a cartridge via a reusable pen (humapen ergo ii), 13 units daily, via unknown route, for diabetes mellitus, beginning on an unknown date in 2016.Start date of humapen ergo ii was unknown.On an unknown date, she suffered from hyperglycemia sometimes if she did not administer the medications.On an unknown date in (b)(6) 2022, while on insulin lispro therapy, she suffered from numbing all over the body before and during the hyperglycemia and had vomiting due to which she was hospitalized.The health care professional gave her certain doses of insulin lispro and then she was taking 10 units in the morning, 12 units in afternoon and 18 units in the evening of the insulin lispro therapy.She then suffered from urinary tract infection that according to the physician affected the blood glucose level to be 400 to 500 (units not provided) and acetone to 3 (units and reference ranges were not provided) and after the recovery from the urinary tract infection the physician decreased the daily units of insulin lispro to 13 units per day.The event of hypoglycemia was considered as serious by the company due to medically significant reason.On an unknown date in (b)(6) 2022, the cartridge got empty fast as the nearest cartridge used was on (b)(6) 2022 and it got empty on (b)(6) 2022 although the units that she administered was not supposed to empty the cartridge in such duration as she was taking 6 units in morning and 6 units in afternoon and 01 unit at evening and sometimes she might correct the blood glucose level with 2 units.After she administered the insulin lispro dose with humapen ergo ii, she suffered from hypoglycemia as the blood glucose range from 30 to 80 postprandial so she tried to administer the insulin lispro with insulin needle and did not suffer from hypoglycemia.It was thought that the humapen ergo ii was the problem (b))(4) and lot no 1709d02) as it was giving more insulin doses than adjusted which caused hypoglycemia.The outcome of events hypoglycemia, hyperglycemia (both episodes), body numbness and urinary tract infection were resolved, and outcome of remaining events was unknown.Corrective treatment details were not provided.Status of insulin lispro therapy was continued.The operator of the humapen ergo ii was unknown and his/her training status was not provided.The device model and the suspect humapen ergo ii duration of use was not provided.The action taken with the humapen ergo ii was unknown and the device was not returned to the manufacturer for investigation.The initial reporting consumer related the event of hypoglycemia with insulin lispro therapy and with humapen ergo ii.The initial reporting consumer did not relate the events of hyperglycemia (serious event), body numbness and urinary tract infection with insulin lispro therapy and with humapen ergo ii while did not provide the relatedness of remaining events with lispro therapy and with humapen ergo ii.Edit 09aug2022: updated medwatch fields for expedited device reporting.No new information added.Update 01sep2022: additional information received on 26aug2022 from the global product complaint database.Entered device specific safety summary (dsss) for humapen luxura burgundy device associated with (b)(4), lot 1709d02.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Added date of manufacture for the 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
• 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: 15217267
• MDR Text Key: 297794332
• Report Number: 1819470-2022-00052
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1709D02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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): Hospitalization; Other
• Patient Age: 12 YR
• Patient Sex: Female