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

Model Number MS9557

Device Problem Inaccurate Delivery (2339)

Patient Problems Missed Dose (2561); Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

Since the device is not being returned, evaluation for a malfunction is not possible.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 compliant: (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 female patient.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50) from a cartridge via a reusable device humapen ergo ii 10 iu in the morning and 10 iu in the evening twice a day subcutaneously for treatment of diabetes mellitus beginning approximately in 2013 or 2014.On an unknown date while taking insulin lispro protamine suspension 50%/insulin lispro 50% treatment she had unstable blood glucose (values, units and reference range were not provided) and diabetic complications and due to both she was hospitalized on (b)(6) 2019 for eleven days.On (b)(6) 2019 she was discharged from the hospital.On (b)(6) 2019 on physician advice she discontinued insulin lispro protamine suspension 50%/insulin lispro 50% treatment and change to insulin suxiulin.Further injection button of a humapen ergo ii sometimes pushed down two units (pc: 4838266; lot number: 1112d01) she was also using humapen ergo ii with unspecified non-lilly insulin.Information regarding corrective treatment and outcome of the events was not provided.It was unknown if she would re-start insulin lispro protamine suspension 50%/insulin lispro 50% treatment or not.No additional follow-up would be attempted as the reporter refused to be followed up via phone and no physician contact information was provided.The operator of the humapen ergo ii was unknown and his/her training status was 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 2013 or 2014 and at the time of the glucose event it had been used for about five or six years.The suspect humapen ergo ii device was continued and its return status was not expected.The reporting consumer did not know of relatedness assessment between the events and insulin lispro protamine suspension 50%/insulin lispro 50% treatment whereas did not provide any opinion on relatedness assessment between the events and did not provide any opinion on relatedness assessment between the events device.Update (b)(6) 2019: both the information received on 12-aug-2019 was processed together.Edit on (b)(6) 2019: on review updated device paragraph with general model duration used and model duration used.Edit on (b)(6) 2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update (b)(6) 2019: additional information was received from the initial reporting consumer on 29-aug-2019.Added one non-serious event of missed dose.Updated causality statement and narrative with new information.

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 13sep2019 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that while using a humapen ergo ii device, she had diabetic complications in (b)(6) 2019.Subsequently, she began using a non-lilly insulin in the ergo ii device, and reported the injection button "sometimes was pushed down to the end directly" and sometimes "was pushed down to half dose directly, then it was pushed normally." the patient felt the injection button slipped rather than was pushed down.The patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (1112d01, manufactured december 2011).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review did not identify any atypical findings with regard to dose accuracy or uneven injection force issues.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reportedly used the device for five or 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.Regarding using another manufacturer's insulin, the core instructions for use states humapen ergo ii is "for use only with lilly 3 ml insulin cartridges (100 iu/ml or units/ml).Do not use other brands of insulin cartridges." there is evidence of improper use.The patient used the device beyond the recommended use period.It is unknown if this misuse is relevant to the event of abnormal blood glucose.The patient used non-lilly insulin cartridge in the device.This misuse may be relevant to the complaint but it is unknown if this is relevant to the event of abnormal blood glucose.

Event Description

Lilly case id: (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-years-old asian female patient.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50) from a cartridge via a reusable device humapen ergo ii 10 iu in the morning and 10 iu in the evening twice a day subcutaneously for treatment of diabetes mellitus beginning approximately in 2013 or 2014.Since an unknown date, it was noted that the injection button of the humapen ergo ii sometimes pushed down two units.It was further noted, the injection button of humapen ergo ii sometimes was pushed down to the end directly, sometimes the injection button was pushed down to half of the dose directly, then it was pushed normally.She felt the injection button slipped rather than was pushed down (product complaint (b)(4)/lot number 1112d01).She doubted insulin was not injected into body due to humapen ergo ii problems (possible missed dose).On an unknown date while taking insulin lispro protamine suspension 50%/insulin lispro 50% treatment she had unstable blood glucose (values, units and reference range were not provided) and diabetic complications and due to both she was hospitalized on (b)(6) 2019 for eleven days.On (b)(6) 2019 she was discharged from the hospital.On (b)(6) 2019 on physician advice she discontinued insulin lispro protamine suspension 50%/insulin lispro 50% treatment and change to insulin suxiulin.It was noted she was also using humapen ergo ii with unspecified non-lilly insulin.Information regarding corrective treatment and outcome of the events was not provided.It was unknown if she would re-start insulin lispro protamine suspension 50%/insulin lispro 50% treatment or not.No additional follow-up would be attempted as the reporter refused to be followed up via phone and no physician contact information was provided.The operator of the humapen ergo ii was unknown and his/her training status was not provided.The general model duration of use for the humapen ergo ii was not provided and the suspect humapen ergo ii duration of use was approximately six years (as it was started approximately in 2013 or 2014 and at the time of the glucose event it had been used for about five or six years).The suspect humapen ergo ii device associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know of relatedness assessment between the events and insulin lispro protamine suspension 50%/insulin lispro 50% treatment whereas did not provide any opinion on relatedness assessment between the events and did not provide any opinion on relatedness assessment between the events device.The initial reporting consumer did not provide relatedness assessment between the event of missed dose insulin lispro mix 50 drug and humapen ergo ii device.Update 14-aug-2019: both the information received on 12-aug-2019 was processed together.Edit on 28-aug-2019: on review updated device paragraph with general model duration used and model duration used.Edit on 30aug2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 03-sep-2019: additional information was received from the initial reporting consumer on 29-aug-2019.Added one non-serious event of missed dose.Updated causality statement and narrative with new information.Update 13sep2019: additional information received on 12sep2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information, the european and canadian (eu/ca) device information.Added date of manufacturer for the suspect humapen ergo ii device associated with product complaint (b)(4), which was not returned to the manufacturer.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
• MDR Report Key: 8981640
• MDR Text Key: 161409993
• Report Number: 1819470-2019-00155
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1112D01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Weight: 55