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

Model Number MS9662

Device Problems Break (1069); Crack (1135); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Hyperglycemia (1905); Foreign Body In Patient (2687)

Event Date 01/31/2015

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

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a (b)(6) year old female patient of asian ((b)(6)) origin.Medical history included foreign body behind chest.Family history included mother and younger sister had diabetes.Concomitant medications included acarbose for the treatment of diabetes mellitus.The patient received human insulin (rdna) injections (humulin unspecified type, 100iu/ml) from a cartridge, via a reusable humapen luxura burgundy (red, metal material), twice daily (morning; 12 unit, night; 8-10 unit) subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date approximately in 2002 (as reported from 16 or 17 years ago).On an unknown date in 2015 (four years ago) blood glucose was high, value was 27 (units and reference range were not provided), she was uncomfortable.Therefore, she had hospitalization (dates for hospitalization were not provided).Following doctor advice on an unknown date in 2015 (four years ago), she changed to use insulin lispro (rdna origin) injections (humalog specific type was unknown), twice daily (morning; 28 unit, night; 20 unit) subcutaneously for the treatment of diabetes mellitus.In the summer (b)(6) , fundus hemorrhage was removed by laser (the specific time was not known), and other information was not known.The event of fundus hemorrhage was considered as serious by company due to its medically significance.Information regarding further corrective treatment was not provided.Outcome of the events was unknown.On (b)(6) 2019, it was noted that the core of the pen was embolized and the core frame was broken, also described the cartridge was detached and the cartridge holder of the humapen was cracked; therefore, the device could not be used (product complaint (b)(4)/lot number 1006b03).It was unknown if human insulin therapy would be restarted.Therapy with insulin lispro was ongoing.The patient was the operator of the humapen luxura burgundy reusable device and her training status was not provided.The general device model duration of use and suspect humapen luxura burgundy device duration of use was 16 years.The status of suspect reusable device was unknown and the return of suspect reusable device was not provided.The reporting consumer did not provide relatedness assessment between the events and human insulin and insulin lispro drugs and humapen luxura burgundy device.Update 04apr2019: product complaints (pc) received on 04apr2019.Product complains processed.No other change was performed in the case.Update 10apr2019: additional information received on 10apr2019 from global product complaint database.Changed the lot number from unknown to 1006b03 for product complaint (b)(4) relating to the humapen luxura burgundy device.Corresponding fields and narrative updated accordingly.Edit 12apr2019: updated medwatch 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 statement dated 06may2019 in the b.5.Field.No further follow up is planned.Evaluation summary: a female patient reported that the cartridge holder of her humapen luxura device was cracked and "the plunger of the cartridge was detached." the patient experienced increased blood glucose.Investigation of the returned device (batch 1006b03, manufactured june 2010) found the cartridge holder was not cracked; however the cartridge holder trim ring silver plating was discolored and peeling, which is evidence of exposure to an unknown chemical while in the field.Additionally, the foot was detached with unknown tool marks present on the nub of the injection screw, caused by excessive force while in the field.Due to the field damage, a functional assessment could not be performed.Malfunction confirmed.The patient reportedly used the current device for 16 years.Based on the manufacturing date, the use period of the pen could not have exceeded 9 years.The core instructions for use state the humapen luxura device has been designed to be used for up to 6 years after first use.In addition, 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.There is evidence of improper use.The damage sustained by the device is consistent with exposure to excessive force and an unknown chemical while in the field (not related to the manufacturing process).In addition, the device was used beyond its approved use life.It is unknown if these use issues are relevant to the event of increased blood glucose.

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned a 52 year old female patient of asian (han) origin.Medical history included foreign body behind chest.Family history included mother and younger sister had diabetes.Concomitant medications included acarbose for the treatment of diabetes mellitus.The patient received human insulin (rdna) injections (humulin unspecified type, 100iu/ml) from a cartridge, via a reusable humapen luxura burgundy (red, metal material), twice daily (morning; 12 unit, night; 8-10 unit) subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date approximately in 2002 (as reported from 16 or 17 years ago).On an unknown date in 2015 (four years ago) blood glucose was high, value was 27 (units and reference range were not provided), she was uncomfortable.Therefore, she had hospitalization (dates for hospitalization were not provided).Following doctor advice on an unknown date in 2015 (four years ago), she changed to use insulin lispro (rdna origin) injections (humalog specific type was unknown), twice daily (morning; 28 unit, night; 20 unit) subcutaneously for the treatment of diabetes mellitus.In the summer yester, fundus hemorrhage was removed by laser (the specific time was not known), and other information was not known.The event of fundus hemorrhage was considered as serious by company due to its medically significance.Information regarding further corrective treatment was not provided.Outcome of the events was unknown.On (b)(6) 2019, it was noted that the core of the pen was embolized and the core frame was broken, also described the cartridge was detached and the cartridge holder of the humapen was cracked; therefore, the device could not be used (product complaint (b)(4)/lot number 1006b03).It was unknown if human insulin therapy would be restarted.Therapy with insulin lispro was ongoing.The patient was the operator of the humapen luxura burgundy reusable device and her training status was not provided.The general device model duration of use and suspect humapen luxura burgundy device duration of use was 16 years.The status of suspect reusable device was unknown and the suspect reusable device was returned to the manufacturer on 10apr2019.The reporting consumer did not provide relatedness assessment between the events and human insulin and insulin lispro drugs and humapen luxura burgundy device.Update 04apr2019: product complaints (pc) received on 04apr2019.Product complains processed.No other change was performed in the case.Update 10apr2019: additional information received on 10apr2019 from global product complaint database.Changed the lot number from unknown to 1006b03 for product complaint (b)(4) relating to the humapen luxura burgundy device.Corresponding fields and narrative updated accordingly.Edit 12apr2019: updated medwatch fields for expedited device reporting.No new information added.Update 30-apr-2019: information received on 29-apr-2019 from affiliate regarding unsuccessful follow up attempt.Patient had been called for many times but did not answer the phone.No medically significant changes were performed.Update 06may2019: additional information received on 30apr2019 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 yes (not cirm), and device return status to returned to manufacturer.Added the date of manufacture and date returned to manufacturer for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8554937
• MDR Text Key: 143405859
• Report Number: 1819470-2019-00065
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1006B03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 55