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 Problems Syncope (1610); Fainting (1847); Hypoglycemia (1912); Seizures (2063)

Event Type  Injury  

Manufacturer Narrative

No further follow up is planned.Evaluation summary the male patient reported that it was possible that he received a higher dose of insulin instead of the correct prescribed dose when using a humapen luxura device.He experienced hypoglycemic seizure and unconsciousness.The device was not returned for investigation (batch (b)(4), manufactured july 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of for the batch did not identify any atypical trends with regard to pen jams or dose accuracy.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy.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 an adverse event and a product complaint, concerns a male patient of unknown origin and age ((b)(6)).Medical history included: kidney and heart disorder.Concomitant medications included: synthroid, omeprazole, isosorbide mononitrate, carvedilol, furosemide, simvastatin and unspecified medication called hidrosalina, gincardio, and marevan all for unknown indication.The patient received 50% insulin lispro + 50% npl (humalog mix 50), dose unknown, three times a day, route of administration unknown, indication for use unknown and start date in 2013.Reported as since beginning 50% insulin lispro + 50% npl via humapen luxura burgundy (batch number (b)(4)), the patient experienced three episodes of fainting and syncope due to hypoglycemia (the three episodes of fainting and seizure due to hypoglycemia were considered serious by the company due to its medically significance).It was also stated that the patient possible received a higher dose instead of the correct prescribed dose ((b)(4)/ lot1307b06) or stated as maybe that he had not feeding properly, and due to that he experienced those fainting hypoglycemia and seizure hypoglycemia.The patient did not receive a corrective treatment for blood glucose increased, fainting and seizure and they were not recovered.It was also stated that the sealed cartridge was storage outside the fridge and it was thought that the 50% insulin lispro + 50% npl was not effective once the patient experienced blood sugar increased on unspecified date.Corrective therapy and blood sugar increased outcome was not provided.No laboratory exams were provided.The 50% insulin lispro + 50% npl therapy was ongoing.The patients caregiver was the operator of device and it was unknown if she was a trained user.It was unknown how long the patient had been using this device model and the reported device.There was no improper use and storage for the device.The device was not returned.The reporting consumer related the hypoglycemic unconsciousness, hypoglycemic seizure to the 50% insulin lispro + 50% npl therapy.The reporting consumer did not provide a relatedness opinion between the remaining events and 50% insulin lispro + 50% npl therapy.Edit on 06may2016.Upon internal review, it was corrected the hypoglycemic unconsciousness event from unlisted to listed on uspi label.Field was updated accordingly.Update 09may2016: additional information received on 05may2016 from the initial reporter.Added the device type in the case.Field and narrative were updated accordingly.Edit on 09may2016: upon internal review it was updated eu ca information according to the device model.Fields were updated accordingly.Edit on 10may2016: upon internal review, since there was no improper use and storage for the device, the improper use or storage field was changed from yes to no.Fields and narrative were updated accordingly.Update 21jun2016: additional information received on 21jun2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added that the device was not returned; 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; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5750499
• MDR Text Key: 48198838
• Report Number: 1819470-2016-00118
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1307B06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• 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 MIX 50
• Patient Outcome(s): Other
• Patient Weight: 70