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

Model Number MS9557

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670); Mechanical Jam (2983); Mechanics Altered (2984)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

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 56-year-old female patient of unknown origin.Medical history included cataract and was hospitalized for cataract.Concomitant medication included acarbose, blood activating and stasis-eliminating drug.The patient received human insulin (rdna) (rdna origin) (humulin series) cartridge) via reusable pen device (humapen ergo ii), at an unknown dose and frequency via subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date, her preexisting cataract possibly worsened, after using insulin human she had three cataract operation and third time she had laser surgery on her eyes.After the treatment, the eyes had improved, and her vision was good.She needed to wait 30 minutes then she could eat meals, it was relatively troublesome, therefore she followed the doctors advice to change to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) from cartridge via reusable pen device (humapen ergo ii), morning 24 units, noon 5 units, night 20 units three times a day, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date, she experienced issue with the first humapen ergo ll insulin leaked from the pen (batch unknown, pc (b)(4)).On an unknown date, she experienced that her diabetes mellitus was not controlled, and she had high blood glucose (no units and reference range provided) and was often hospitalized due to diabetes mellitus and high blood glucose.On an unknown date, she had uric acidosis and was hospitalized to treat twice due to uric acidosis.On an unknown date, she had wrist fracture due to which she had been hospitalized on (b)(6) 2022.On (b)(6) 2022, or (b)(6) 2022, with the second pen, it was found that the ergoll injection button could not pressed and sometimes the injection button could be pressed but it was difficult to press it (batch 1105d02, (b)(4)).At the time of report she was not discharge from the hospital and she prepared to be discharged and back home on (b)(6) 2022.It was reported that she stored the pen with needle attached and could not prime the pen was considered as improper use.Information about remaining corrective treatment, further hospitalization details was unknown.Outcome of the events cataract possible worsened and uric acidosis was recovering.Outcome of the remaining events was unknown.Status of human insulin was unknown and insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The patient was the operator of the humapen ergo ii devices and her training status was not provided.The general model device duration and the suspect humapen ergo ii devices duration of use was not provided.Action taken with the suspect humapen ergo ii devices was not and its return status was not provided.The reporting consumer did not know if the events were related to the insulin human and insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not provide an opinion of relatedness of the events to the humapen ergo ii devices.Edit 16sep2022: 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.This report is associated with 1819470-2022-00072 since there is more than one device implicated.

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 56-year-old female patient of unknown origin.Medical history included cataract and was hospitalized for cataract.Concomitant medication included acarbose, blood activating and stasis-eliminating drug.The patient received human insulin (rdna) (rdna origin) (humulin series) cartridge) via reusable pen device (humapen ergo ii), at an unknown dose and frequency via subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date, her preexisting cataract possibly worsened, after using insulin human she had three cataract operation and third time she had laser surgery on her eyes.After the treatment, the eyes had improved, and her vision was good.She needed to wait 30 minutes then she could eat meals, it was relatively troublesome, therefore she followed the doctors advice to change to insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) from cartridge via reusable pen device (humapen ergo ii), morning 24 units, noon 5 units, night 20 units three times a day, subcutaneously for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date, she experienced issue with the first humapen ergo ll insulin leaked from the pen (batch unknown, (b)(4).On an unknown date, she experienced that her diabetes mellitus was not controlled, and she had high blood glucose (no units and reference range provided) and was often hospitalized due to diabetes mellitus and high blood glucose.On an unknown date, she had uric acidosis and was hospitalized to treat twice due to uric acidosis.On an unknown date, she had wrist fracture due to which she had been hospitalized on (b)(6) 2022.On (b)(6) 2022, with the second pen, it was found that the ergoll injection button could not pressed and sometimes the injection button could be pressed but it was difficult to press it (batch 1105d02, (b)(4).At the time of report she was not discharge from the hospital and she prepared to be discharged and back home on (b)(6) 2022.It was reported that she stored the pen with needle attached and could not prime the pen was considered as improper use.Information about remaining corrective treatment, further hospitalization details was unknown.Outcome of the events cataract possible worsened and uric acidosis was recovering.Outcome of the remaining events was unknown.Status of human insulin was unknown and insulin lispro protamine suspension 75%/insulin lispro 25% was ongoing.The patient was the operator of the humapen ergo ii devices and her training status was not provided.The general model device duration and the suspect humapen ergo ii devices duration of use was not provided.Action taken with the suspect humapen ergo ii devices was not and its return status was not provided.The reporting consumer did not know if the events were related to the insulin human and insulin lispro protamine suspension 75%/insulin lispro 25% therapy and did not provide an opinion of relatedness of the events to the humapen ergo ii devices.Edit 16sep2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 19oct2022: additional information received on 13oct2022 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 associated with (b)(4).Updated malfunction from unknown to yes, and device return status to returned to manufacturer; and added date of manufacture and date returned to manufacturer for the suspect humapen ergo ii associated with (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 19oct2022 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2022-00072 since there is more than one device implicated.Evaluation summary: a female patient reported that the injection button of her humapen ergo ii device "could not pressed and sometimes the injection button could be pressed but it was difficult to press it." the patient experienced inadequate control of diabetes mellitus.The investigation of the returned device (batch 1105d02, manufactured may 2011) found foreign material on multiple internal components of the device, which caused mechanical difficulties that prevented the device from functioning as designed.In addition, the investigation found glue-like foreign material on the dial and lens of the device, and the soft touch was partly de-bonded with evidence of excessive force observed.Malfunction confirmed.The foreign material contamination occurred in the field and was not related to the manufacturing process.The core instructions for use states that the injection button may become harder to push if the inside of the pen gets dirty with insulin, food, drink or other materials.Following the care and storage instructions should help prevent this.The patient stored the pen with the needle attached.The core instructions for use state to not store the pen with the needle attached.While it is unknown how long the patient used the device, based on the amount of time elapsed since the device was manufactured (may 2011), it is likely the patient used it beyond its approved use life.The core instructions for use state the humapen ergo has been designed to be used for up to 3 years after first use.There is evidence of improper use and storage.The patient stored the pen with the needle attached and likely used the device beyond its approved use life.It is unknown if these misuses are relevant to the event of inadequate control of diabetes mellitus.

• 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
• MDR Report Key: 15439894
• MDR Text Key: 300070711
• Report Number: 1819470-2022-00073
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1105D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2011
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian