MAUDE Adverse Event Report: ELI LILLY AND COMPANY HP LUXURA, BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problem Break (1069)

Patient Problems Hyperglycemia (1905); Visual Disturbances (2140)

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 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)-year-old asian female patient of (b)(6) nationality.Medical history was none.Concomitant medication included an unspecified traditional (b)(6) medicine for an unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50, 100 u/ml) from a cartridge, via a reusable pen humapen luxura, burgundy, 20u in morning and 18u at night two times a day subcutaneously for the treatment of diabetes mellitus beginning sometime in 2009.She started using humapen luxura, burgundy from 2009.On an unknown date, while on insulin lispro protamine suspension 50%/insulin lispro 50% treatment, she experienced hyperglycemia as her blood glucose was high which was not controlled well (values, units and reference range not provided) due which she was hospitalized on an unknown date.Also, since an unknown date, she had presbyopia because of which she could not see clearly without glasses and could only see 2020.She did not wear glasses.On (b)(6) 2019, the injection screw of humapen luxura, burgundy was cracked (pc# (b)(4), lot#: 0901b01).Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was discontinued on (b)(6) 2019 (unknown reason) and it was unknown whether she would re-start treatment or not.The operator of the humapen luxura, burgundy was the patient and her training status was not provided.The humapen luxura, burgundy model duration of use was not reported but it was started sometime in 2009.The suspect humapen luxura, burgundy duration was approximately 10 years.The action taken with suspect humapen luxura, burgundy and its return status was not provided.The reporting consumer did not know whether the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% treatment or not.No assessment of relatedness was provided for the events with suspect humapen luxura, burgundy edit 25apr2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.

Manufacturer Narrative

B.5.Narrative field: new, updated and corrected information is referenced within the update statements in b.5.Please refer to update.No further follow-up is planned.Evaluation summary a female patient reported that the injection screw of her humapen luxura device was cracked.The patient experienced hyperglycemia.The investigation of the returned device (batch 0901b01, manufactured january 2009) found the injection screw was broken, rendering the device non-functional.Malfunction confirmed.The damage to the injection screw indicates the device was damaged while in the field, as this type of damage would have been detected during the manufacturing inspection process.The core instructions for use state to not use the device if it appears broken or damaged and to contact lilly or a healthcare professional for a replacement pen.The patient reported using the device for approximately 10 years.The core instructions for use state the humapen luxura has been designed to be used for up to 6 years after first use.The patient also reported that she could not see clearly (presbyopia).The core instructions for use state that the device is not recommended for the blind or the visually impaired without the assistance of a sighted individual trained to use the device.There is evidence of improper use.The damage to the device occurred while in the field (not related to the manufacturing process).The patient used the device while visually impaired and used the device beyond the recommended use period.It is unknown if these misuses are relevant to the event of hyperglycemia.

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 56-year-old asian female patient of han nationality.Medical history was none.Concomitant medication included an unspecified traditional chinese medicine for an unknown indication.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50, 100 u/ml) from a cartridge, via a reusable pen humapen luxura burgundy, 20u in morning and 18u at night two times a day subcutaneously for the treatment of diabetes mellitus beginning sometime in 2009.She started using humapen luxura burgundy from 2009.On an unknown date, while on insulin lispro protamine suspension 50%/insulin lispro 50% treatment, she experienced hyperglycemia as her blood glucose was high which was not controlled well (values, units and reference range not provided) due which she was hospitalized on an unknown date.Also, since an unknown date, she had presbyopia because of which she could not see clearly without glasses and could only see 2020.She did not wear glasses.On (b)(6) 2019 the injection screw of humapen luxura burgundy device was cracked (pc: 4711527, lot number: 0901b01).Information regarding further hospitalization details, corrective treatment and outcome of the events was not provided.Insulin lispro protamine suspension 50%/insulin lispro 50% treatment was discontinued on (b)(6) 2019 (unknown reason) and it was unknown whether she would re-start treatment or not.The operator of the humapen luxura burgundy was the patient and her training status was not provided.The humapen luxura burgundy model duration of use was not reported but it was started sometime in 2009.The suspect humapen luxura burgundy duration was approximately 10 years.The suspect humapen luxura, burgundy device associated with pc 4711527 was returned to the manufacturer on 28apr2019.The reporting consumer did not know whether the events were related to insulin lispro protamine suspension 50%/insulin lispro 50% treatment or not.No assessment of relatedness was provided for the events with suspect humapen luxura burgundy device.Edit 25apr2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 03jun2019: additional information received on 03jun2019 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, malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer.Added date of manufacturer and date returned to manufacturer for the suspect humapen luxura burgundy device associated with pc 4711527.Corresponding fields and narrative updated accordingly.

• Brand Name: HP LUXURA, BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8600565
• MDR Text Key: 144838292
• Report Number: 1819470-2019-00086
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Device Lot Number: 0901B01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2019
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 51