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

Model Number MS9662

Device Problem Failure to Advance (2524)

Patient Problems Blurred Vision (2137); Test Result (2695)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem.Please refer to statement dated 30nov2016 in describe event or problem.Evaluation summary a male patient reported the injection screw of his humapen luxura device "could not move sometimes," and the "injection button could not be pushed down." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured november 2011).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 and dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events, concerned an (b)(6) male patient of unspecified origin.Medical history included athletes foot, cataract surgery and family drug reaction to most drugs.Concomitant medications were not reported.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25) from a cartridge via a reusable pen (humapen luxura burgundy) 20 units in the morning and 18 units at evenings subcutaneously for the treatment of diabetes mellitus; beginning sometime in 2013.On an unknown date, he could not see clearly, it was more severe than before.On (b)(6) 2016, his fasting blood glucose was 20 (no units or reference ranges provided); he was hospitalized.On (b)(6) 2016, he was discharged from the hospital after his blood glucose was stable (no values provided).Date of hospitalization was not reported.By (b)(6) 2016, he was recovering from the fasting blood glucose.On an unreported date, he had a product complaint against the humapen luxura ((b)(4)/ lot 1111b04).Information regarding further corrective treatment was not reported.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy was continued.The user of the humapen luxura burgundy and his training status was not provided.The humapen luxura burgundy model duration started in 2013 and its duration of use was about 3 years.The device was not returned.The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% or with its humapen luxura burgundy.Update 18-nov-2016: upon review, this case was opened to add the medwatch and european and canadian required device reporting elements to the case for regulatory reporting; added the product complaint information and number to the case; and updated the narrative.Update 30nov2016.Follow up received 30nov2016 from the product complaint safety database.On the device tab entered the date of manufacture, entered the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the device medwatch information, and the narrative was 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
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 6147475
• MDR Text Key: 61537310
• Report Number: 1819470-2016-00310
• 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
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1111B04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2011
• 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: HUMALOG
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Weight: 89