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

Model Number MS9557

Device Problems Failure to Deliver (2338); Mechanical Jam (2983); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 04/01/2023

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous device only case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerns a 53-year-old asian male patient of han origin.Medical history and concomitant medications were none.The patient began taking an unspecified insulin (from eli lilly) via a reusable device, humapen ergo ii, 20 units in the morning and 12-13 in the evening; twice a day, by subcutaneous route, for treatment of type i diabetes mellitus, beginning from 2005.On an unspecified date in (b)(6) 2023 the humapen ergo ii injection button was pushed down to the end directly without clicking sounds.Due to this malfunction the pen could not push insulin out.The patient found that his blood glucose was high in the body examination on (b)(6) 2023.It was found that the pre-prandial blood glucose was 21.0-22.0 (unit not provided), the postprandial blood glucose was 18.0-19.0 and 15.0-16.0 (pc number:(b)(4)/ lot number: 1008d01).Later he was hospitalized for regulating blood glucose.Also it was found his blood pressure was on the high side in the examination.The bottom number(diastolic) was 90-100, and the top (systolic) was 142 (unit not provided) and the blood lipid was a little higher.Events were resolving.Treatment measures was not provided.Status of the unspecified insulin was ongoing.Follow up was not possible as the reporter was not willing to be followed up via phone and treating physician name and address was not provided.The user of the suspect device and training status of user not provided.The general device duration of use and the suspect device duration of use was not provided.Action taken with suspect device was not provided but it was available for return.The reporting consumer did not know relatedness for the events with unspecified insulin, and related event of blood glucose increased with humapen ergo ii.Edit 26apr2023: 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 dated 01may2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device "was pushed down to the end directly without clicking sounds and the humapen could not push insulin out." the patient experienced increased blood glucose.The investigation of the returned device (batch 1008d01, manufactured august 2010) found the pen body was cracked and the soft touch was peeled off, with evidence of excessive force observed for both issues.However, the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.Based on the date the device was manufactured (august 2010), the device was likely beyond the recommended use life.The core instructions for use state 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 damage to the device is consistent with damage while in the field and the user likely used the device beyond its recommended use period.These misuses are not likely relevant to the event of increased blood glucose since the device met functional requirements and met dose accuracy and glide (injection) force specifications.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous device only case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerns a 53-year-old asian male patient of han origin.Medical history and concomitant medications were none.The patient began taking an unspecified insulin (from eli lilly) via a reusable device, humapen ergo ii, 20 units in the morning and 12-13 in the evening; twice a day, by subcutaneous route, for treatment of type i diabetes mellitus, beginning from 2005.On an unspecified date in (b)(6) 2023 the humapen ergo ii injection button was pushed down to the end directly without clicking sounds.Due to this malfunction the humapen could not push insulin out.The patient found that his blood glucose was high in the body examination on (b)(6) 2023.It was found that the pre-prandial blood glucose was 21.0-22.0 (unit not provided), the postprandial blood glucose was 18.0-19.0 and 15.0-16.0 (pc number: (b)(4)/ lot number: 1008d01).Later he was hospitalized for regulating blood glucose.Also it was found his blood pressure was on the high side in the examination.The bottom number(diastolic) was 90-100, and the top (systolic) was 142 (unit not provided) and the blood lipid was a little higher.Events were resolving.Treatment measures was not provided.Status of the unspecified insulin was ongoing.Follow up was not possible as the reporter was not willing to be followed up via phone and treating physician name and address was not provided.The user of the suspect device and training status of user not provided.The device was used beyond the recommendation.Action taken with suspect device was not provided.The device was returned to manufacturer on 10apr2023 and device met functional requirements.The reporting consumer did not know relatedness for the events with unspecified insulin, and related event of blood glucose increased with humapen ergo ii.Edit 26apr2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 01may2023: additional information received on 25apr2023 from the global product complaint database.Entered device specific safety summary (dsss) for humapen ergo ii device associated with (b)(4), lot 1008d01.Updated the medwatch fields/ european and canadian (eu/ca) device information and device return status was updated as returned to manufacturer and return date was updated.Added date of manufacturer for the device, device malfunction was updated from unknown to no and device met functional requirements.Also, improper use or storage was updated from no to yes.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
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe 85281
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis 46285 ; 3174334585
• MDR Report Key: 16836465
• MDR Text Key: 314221541
• Report Number: 1819470-2023-00030
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1008D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2010
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian