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

Model Number MS9662

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

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 solicited case, reported by a consumer via a patient support program (psp), concerned a 79-year-old asian male patient.Medical history was not provided.Concomitant medication included metformin and acarbose, both for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) cartridge, via humapen luxura burgundy, unknown dose at unknown frequency, via an unknown route of administration, for treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2018.On an unknown date, while on insulin lispro protamine suspension 75%/insulin lispro 25% treatment, he had high blood glucose (no unit, value or reference range was provided).On (b)(6) 2019, he was hospitalized to regulate blood glucose due to high blood glucose.Also, his humapen luxura burgundy injection button was loose (lot number: 1309b07, pc number: (b)(4)).Information regarding corrective treatment and outcome of the event was unknown.On (b)(6) 2019, he was discharged from the hospital.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was ongoing.The operator of humapen luxura and his/her training status was not provided.The general humapen luxura model duration of use and suspect humapen luxura duration of use was not provided but it was started on an unknown date in (b)(6) 2018.Suspect humapen luxura was ongoing and its return was expected.The initial reporting consumer did not know if the event was related to insulin lispro protamine suspension 75%/insulin lispro 25% therapy.Edit 17jul2019: updated medwatch fields for expedited device reporting.No new information added.Edit 18-jul-2019: updated narrative with device lot and product complaint number, and product complaint description.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 79-year-old asian male patient.Medical history was not provided.Concomitant medication included metformin and acarbose, both for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) cartridge, via humapen luxura (burgundy), unknown dose at unknown frequency, via an unknown route of administration, for treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2018.In early 2019, it was noted that the injection button of his humapen luxura was loose (lot number: 1309b07, pc number: (b)(4).On an unknown date, while on insulin lispro protamine suspension 75%/insulin lispro 25% treatment, he had high blood glucose (no unit, value or reference range was provided).On (b)(6) 2019, he was hospitalized to regulate blood glucose due to high blood glucose.Information regarding corrective treatment and outcome of the event was unknown.On (b)(6) 2019, he was discharged from the hospital.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was ongoing.The operator of humapen luxura and his/her training status was not provided.The general humapen luxura model duration of use and suspect humapen luxura duration of use was not provided but it was started on an unknown date in (b)(6) 2018; approximately 1 year.The suspect device, which was manufactured in (b)(6) 2013, was not returned to the manufacturer as a diabetic educator determined the needle was clogged and the issue was resolved.The initial reporting consumer did not know if the event was related to insulin lispro protamine suspension 75%/insulin lispro 25% therapy.Edit (b)(6) 2019: updated medwatch fields for expedited device reporting.No new information added.Edit (b)(6) 2019: updated narrative with device lot and product complaint number, and product complaint description.Update (b)(6) 2019: additional information received on (b)(6) 2019 and (b)(6) 2019 from the global product complaint database which were processed together.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 with lot 1309b07 of a humapen luxura (burgundy) device.Corresponding fields and narrative updated accordingly.

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 (b)(6) 2019 in the b.5.Field.No further follow-up is planned.This is a downgrade report, which no longer meets the criteria for expedited reporting.Evaluation summary: a male a patient reported that the injection button of his humapen luxura device was loose.The patient experienced increased blood glucose.The device was not returned for investigation (batch 1309b07, manufactured september 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.A diabetes educator followed up with the patient, determined the needle was clogged, and the issue was resolved.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use or storage.

• 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: 8856615
• MDR Text Key: 153661324
• Report Number: 1819470-2019-00128
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1309B07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 64