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

Model Number MS9662

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Hyperglycemia (1905); Unspecified Infection (1930); Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

Lilly case id: (b)(6).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp) and with additional information from initial reporter via psp, concerned a (b)(6) year-old (b)(6) male patient.Medical history included a cerebral infarction and a thigh amputation.Concomitant medications included metformin, acarbose, and an unspecified medication referred to as "jinqijiangtangpian", all for unspecified indications.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) via reusable pen (humapen ergo ii), subcutaneously, (b)(4) units three times each day, for the treatment of diabetes mellitus starting in 2012.On an unspecified date, he had legs arterial occlusion.He underwent an unspecified legs suture surgery as corrective treatment.Also on an unspecified date, he experienced blood glucose increased and fever, and because of those events he was hospitalized on (b)(6) 2016.Further information regarding laboratory tests findings was not provided.The cause of fever was diagnosed as a leg infection, with his highest body temperature recorded at 39 to 40 degrees celsius.By (b)(6) 2016 he continued hospitalized.On an unspecified date, there was a product complaint against the humapen ergo ii (pc: (b)(4); lot number: 1201d06).By (b)(6) 2016, the events of leg infection and leg arterial occlusion were recovering.The outcome of the remaining events was not reported.Insulin lispro treatment was continued.The user of the device and his/ her training status was not provided.The device model duration of use and the suspect device duration of use were not reported.The action taken with the suspect device was not provided.If device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting consumer did not know if the events of leg infection and blood glucose increased were related to the insulin lispro and did not provide an assessment of relatedness regarding the remaining events.No follow-up would be pursued as the reporter refused to be contacted and treating physician contact details were not provided.Update 10-nov-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory requirements.The product complaint information was added to the case.Update 18-nov-2016: additional information received on 16-nov-2016 and on 18-nov-2016 from initial reporter via psp were processed at the same time.Recoded the event of fever to leg infection and added new non-serious event of leg arterial occlusion.Narrative was updated accordingly.Upon review of initial information, coded metformin and acarbose as concomitant medications.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a male patient reported the injection button of his humapen luxura device could not be pushed down completely when injecting.The patient experienced increased blood glucose levels.The investigation of the returned device (batch 1201d06, manufactured january 2012) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp) and with additional information from the affiliate and the initial reporter via psp, concerned a (b)(6) asian male patient.Medical history included a cerebral infarction and a thigh amputation.Concomitant medications included metformin, acarbose, and an unspecified medication referred to as jinqijiangtangpian, all for unspecified indications.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) via reusable pen (humapen luxura burgundy), subcutaneously, 14 units three times each day, for the treatment of diabetes mellitus starting in 2012.On an unspecified date, he had legs arterial occlusion.He underwent an unspecified legs suture surgery as corrective treatment.Also on an unspecified date, he experienced blood glucose increased and fever, and because of those events he was hospitalized on (b)(6) 2016.Further information regarding laboratory tests findings was not provided.The cause of fever was diagnosed as a leg infection, with his highest body temperature recorded at 39 to 40 degrees celsius.By (b)(6) 2016 he continued hospitalized.On an unspecified date, there was a product complaint against the luxura burgundy (product complaint (b)(4); lot number: 1201b06).By (b)(6) 2016, the events of leg infection and leg arterial occlusion were recovering.The outcome of the remaining events was not reported.Insulin lispro treatment was continued.The user of the device and his/ her training status was not provided.The device model duration of use and the suspect device duration of use were not reported.The device was returned on 02dec2016, and no malfunction was found.The reporting consumer did not know if the events of leg infection and blood glucose increased were related to the insulin lispro and did not provide an assessment of relatedness regarding the remaining events.No follow-up would be pursued as the reporter refused to be contacted and treating physician contact details were not provided.Update 10-nov-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory requirements.The product complaint information was added to the case.Update 18-nov-2016: additional information received on 16-nov-2016 and on 18-nov-2016 from initial reporter via psp were processed at the same time.Recoded the event of fever to leg infection and added new non-serious event of leg arterial occlusion.Narrative was updated accordingly.Upon review of initial information, coded metformin and acarbose as concomitant medications.Update 02-dec-2016: additional information received on 02-dec-2016 from global product complaint database updated the lot number from 1201d06 to 1201b06 for product complaint (b)(4) which updated the device to a humapen luxura burgundy.The return date of the device was added, and the european and canadian required device reporting elements were updated.The product tab for humapen and the narrative were updated.Update 16-dec-2016: additional information received on 09nov2016 from affiliate.Product complaint reference number was received however it was already processed and present in narrative.No new adverse event information was received.Update 21dec2016: additional information received on 21dec2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; updated the malfunction field to no; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6124575
• MDR Text Key: 60794847
• Report Number: 1819470-2016-00298
• 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: 01/13/2017

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?: Yes
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1201B06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2012
• 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
• Treatment: ACARBOSE; INSULIN LISPRO; METFORMIN
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR