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

Model Number MS9557

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Confusion/ Disorientation (2553)

Event Date 06/30/2020

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 spontaneous case reported by a consumer, who contacted the company to report adverse events, concerned a female patient of unknown age and origin.Medical history was not provided.Concomitant medication included voglibose for unknown indication.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix50) cartridge via a insulin injection pen(humapen, unknown from 2008) 16 units twice a day, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.On an unknown dates, sometimes her pre-prandial blood glucose was higher than postprandial (no unit, value or reference range was provided).Her first insulin pen had some issue around 2013 and it was replaced (lot number: unknown, pc number: (b)(4)).From an unknown date in 2013, she started to use humapen ergo ii (blue plastic).On an unknown date in (b)(6) 2020, the injection button of humapen ergo ii was difficult to press.On an unknown date in (b)(6) 2020 her blood glucose control was poor (lot number: 1201d01, pc number: (b)(4)) and she was hospitalized for it.In addition, she had the condition of brain muddled (confusion).Information regarding corrective treatment and outcome of events was unknown.Insulin lispro protamine suspension 50%/ insulin lispro 50% treatment was continued.No follow-up was possible as reporter did not provide consent and no physician contact details were provided.The patient was the operator of the reusable devices and her training status was not provided.The general device model duration of use for the humapen, unknown device was unknown but it started on an unknown date in 2008.The suspect device duration of use for the humapen, unknown device was not provided.The suspect humapen, unknown device associated with pc (b)(4) was replaced in 2013 and its return was not expected.The general device model duration of use for the humapen ergo ii device was unknown.The suspect device duration of use for the humapen ergo ii device was approximately seven year as it started around 2013.The use of humapen ergo ii device associated with pc (b)(4) (lot 1201d01) was continued and its return was expected.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/ insulin lispro 50% whereas did not provide an opinion of relatedness between the events and unknown humapen and humapen ergo ii.Update 20-jul-2020: initial and follow-up information received on 16-jul-2020 was processed together.Edit 22jul2020: updated medwatch fields for expedited device reporting.No new information added.Edit 23-jul-2020: updated report type from solicited to spontaneous in narrative.

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 29jul2020 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that the injection button of her humapen ergo ii was difficult to press.The patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch 1201d01, manufactured january 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.With the guidance of a trained professional, troubleshooting was performed, including priming the device, and the issue was resolved.A complaint history review of the batch did not identify any atypical findings with respect to dose accuracy issues.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.The patient reported the device was used for seven years.The core instructions for use states the humapen ergo ii has been designed to be used for up to three years after first use.There is evidence of improper use.The patient used the device beyond its approved use life.This misuse is not likely relevant to the event of abnormal blood glucose since the device issue was resolved.

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, concerned a female patient of unknown age and origin.Medical history was not provided.Concomitant medication included voglibose for unknown indication.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) (humalog mix50) cartridge via a insulin injection pen(humapen, unknown from 2008) 16 units twice a day, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date.On an unknown dates, sometimes her pre-prandial blood glucose was higher than postprandial (no unit, value or reference range was provided).Her first insulin pen had some issue around 2013 and it was replaced (lot number: unknown, pc number: (b)(4)).From an unknown date in 2013, she started to use humapen ergo ii (blue plastic).On an unknown date in (b)(6) 2020, the injection button of humapen ergo ii was difficult to press.On an unknown date in (b)(6) 2020 her blood glucose control was poor (lot number: 1201d01, pc number: (b)(4)) and she was hospitalized for it.In addition, she had the condition of brain muddled (confusion).Information regarding corrective treatment and outcome of events was unknown.Insulin lispro protamine suspension 50%/ insulin lispro 50% treatment was continued.No follow-up was possible as reporter did not provide consent and no physician contact details were provided.The patient was the operator of the reusable devices and her training status was not provided.The general device model duration of use for the humapen, unknown device was unknown but it started on an unknown date in 2008.The suspect device duration of use for the humapen, unknown device was not provided.The suspect humapen, unknown device associated with (b)(4) was replaced in 2013 and its return was not expected.The general device model duration of use for the humapen ergo ii device was unknown.The suspect device duration of use for the humapen ergo ii device was approximately seven year as it started around 2013.The use of humapen ergo ii device.Which was manufactured in jan2012, associated with (b)(4) (lot 1201d01) was continued and was not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 50%/ insulin lispro 50% whereas did not provide an opinion of relatedness between the events and unknown humapen and humapen ergo ii.Update 20-jul-2020: initial and follow-up information received on 16-jul-2020 was processed together.Edit 22jul2020: updated medwatch fields for expedited device reporting.No new information added.Edit 23-jul-2020: updated report type from solicited to spontaneous in narrative.Update 29jul2020: additional information received on 29jul2020 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to not returned to manufacturer.Added date of manufacturer for (b)(4) associated to lot 1201d01 of 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
• MDR Report Key: 10322355
• MDR Text Key: 208325201
• Report Number: 1819470-2020-00092
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1201D01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization