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

Model Number MS9662

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Description of problem or event: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 08may2019.No further follow-up is planned.Evaluation summary: a patient reported that the injection button of their humapen luxura device could not be pushed down.The patient experienced abnormal blood glucose.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient reported he began 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.There is evidence of improper use.The patient used the device beyond the recommended use period.It is unknown if this is relevant to the event of abnormal blood glucose.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer to report adverse events and product complaint (pc), concerned a patient of unspecified age, gender and origin.Medical history was unknown and concomitant medications were not provided.The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30, 100iu/ml) via cartridge, at unknown dose and frequency, for the treatment of diabetes mellitus, beginning on an unknown date, using humapen luxura burgundy beginning approximately in 2009.On an unknown date, after starting human insulin isophane suspension 70%/ human insulin 30%, patient was hospitalized every year due to unspecified reason.On an unknown date, possibly blood sugar of patient was not controlled.On an unknown date, humapen luxura burgundy injection button could not be pushed down (pc (b)(4), lot number unknown).Around (b)(6) 2019, patient was hospitalized for blood sugar control and physical examination.Information regarding corrective treatment, outcome of event and status of human insulin isophane suspension 70%/ human insulin 30% treatment was not reported.Follow-up cannot be pursued with hcp as contact details are not available and reporter did not provide consent to be contacted.The operator of the humapen luxura burgundy and his/her training status was not provided.The general humapen luxura burgundy duration of use was not reported.The suspect humapen luxura burgundy duration of use was approximately ten years.The suspect humapen luxura burgundy device associated with product compliant (b)(4) was not returned to the manufacturer.The reporting consumer did not know the opinion of relatedness between event and human insulin isophane suspension 70%/ human insulin 30% or humapen luxura burgundy.Update 01may2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Update 08may2019: additional information received on 07may2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and (b)(4) (eu/(b)(4)) device information for the suspect humapen luxura burgundy device associated with product compliant (b)(4).Corresponding fields and narrative updated accordingly.Upon review, added suspect device age to the device age field.

• 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; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8621444
• MDR Text Key: 145484606
• Report Number: 1819470-2019-00090
• 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
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9662
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization