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

Model Number MS9557

Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a (b)(6) asian male patient.Medical history and concomitant medications were not provided.The patient received insulin human (rdna origin) injections (humulin 100u/ml) via reusable pen, (humapen ergo ii), 17 units in the morning, 13 units at night, two times a day (bid) subcutaneously for the treatment of type 1 diabetes mellitus from an approximate year in 2001 (10-20 years) ago.He started humapen ergo ii approximately in 2015 which was considered as an improper use.On an unknown date, while on insulin human treatment, his humapen ergo ii was partly shelled, degummed and fell off, the insulin injection pen had been used for a few years and there was a little insulin left on the needle after injection ((b)(4) and batch number- 1410d01) and he had high blood glucose (values, units and reference range not provided) and due to which he was hospitalized on an unknown date in 2015.He also had eyes issue (specific situation was not provided) due to which he was hospitalized on an unknown date in (b)(6) 2021.Information regarding corrective treatment, outcome of events and status of insulin human treatment was not provided.The operator of the humapen ergo ii and his/her training status were not provided.The general model humapen ergo ii duration of use was not provided and the suspect humapen ergo ii duration of use was approximately six years as it was started approximately in 2015.The action taken with the suspect humapen ergo ii was not reported and its return status was not expected.The reporting consumer did not provide relatedness of events with insulin human and humapen ergo ii.Update 27oct2021: additional information received on 25oct2021 from global product complaint database.Changed the lot number from unknown to 1410d01 for product complaint (b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Edit 04nov2021: updated medwatch and european and (b)(6) (eu/(b)(6)) 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 23nov2021 in the b.5.Field.No further follow-up is planned.Evaluation summary a male patient reported that his humapen ergo ii device "was partly shelled, degummed and fell off, the insulin injection pen had been used for a few years and there was a little insulin left on the needle after injection." the patient experienced increased blood glucose.The investigation of the returned device (batch 1410d01, manufactured october 2014) found cracks on the pen body and the soft touch was partly de-bonded, 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.The patient reported that the device had been used for six years.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.The core instructions for use also states to always carry a spare insulin pen in case your pen is lost or damaged.There is evidence of improper use.The patient used the device beyond the recommended use period.This misuse is 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 case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a 42-year-old asian male patient.Medical history and concomitant medications were not provided.The patient received insulin human (rdna origin) injections (humulin 100u/ml) via reusable pen, (humapen ergo ii), 17 units in the morning, 13 units at night, two times a day (bid) subcutaneously for the treatment of type 1 diabetes mellitus from an approximate year in 2001 (10-20 years) ago.He started humapen ergo ii approximately in 2015 which was considered as an improper use as use was used approximately 6 years.On an unknown date, while on insulin human treatment, his humapen ergo ii was partly shelled, degummed and fell off, the insulin injection pen had been used for a few years and there was a little insulin left on the needle after injection (pc number- (b)(4) and batch number- 1410d01) and he had high blood glucose (values, units and reference range not provided) and due to which he was hospitalized on an unknown date in 2015.He also had eyes issue (specific situation was not provided) due to which he was hospitalized on an unknown date in (b)(6) 2021.Information regarding corrective treatment, outcome of events and status of insulin human treatment was not provided.The operator of the humapen ergo ii and his/her training status were not provided.The general model humapen ergo ii duration of use was not provided and the suspect humapen ergo ii duration of use was approximately six years as it was started approximately in 2015.It was returned to manufacturer on 25oct2021.The reporting consumer did not provide relatedness of events with insulin human and humapen ergo ii.Update 27oct2021: additional information received on 25oct2021 from global product complaint database.Changed the lot number from unknown to 1410d01 for product complaint(b)(4) relating to the humapen ergo ii device.Corresponding fields and narrative updated accordingly.Edit 04nov2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 19nov2021: additional information received on 17nov2021 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, and device return status to returned to manufacturer; and added date of manufacture and date returned to manufacturer for the suspect device associated with (b)(4) relating to the humapen ergo ii 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: 12759776
• MDR Text Key: 281919109
• Report Number: 1819470-2021-00151
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1410D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian