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 Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.This report is associated with 1819470-2018-00088 since there is more than one device implicated.A female patient reported that her humapen luxura device was not injecting insulin and she did not receive the medication for one day.The patient experienced increased 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.The reported batch number, 1209808, was not a valid batch number; however, it is possible the reporter misread the batch number and the actual batch number is 1209b06, which was marketed in (b)(6).Therefore, a complaint history review was performed on 1209b06 and did not identify any atypical findings with regard to pen jam issues.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.The patient also reported that her device was stored in the refrigerator.The device user manual instructs to not to store the device in a refrigerator.There is evidence of improper use.The patient stores the device in a refrigerator.This misuse is not likely relevant to the event of increased blood glucose.

Event Description

(b)(4).This spontaneous case reported by a consumer who contacted the company via a company representative with a product complaint, with additional information from a second consumer reporter, concerned a (b)(6) female patient of unknown origin.Medical history was not provided.Concomitant medication included insulin glargine and clickstar device.Patient received insulin human (rdna origin) regular (humulin) via reusable device, unknown dose, frequency and via of administration, for unknown indication of use, beginning on unknown date.On (b)(6) 2018, unknown time to onset, patient missed a dose because two devices, a humapen luxura burgundy (lot 1306b02/ (b)(4)), a second humapen luxura burgundy ((b)(4)/lot unknown), both of them were used for more than five years, did not inject the medication properly.On (b)(6) 2018, patient was hospitalized due to high blood glucose higher than 580, and it went up to more than 600 (unit not provided) and experienced dry mouth.Patient was discharged on (b)(6) 2018 with blood glucose at 136, bought a humapen savvio (lot 1411v02 / (b)(4)), which also did not inject the medication.Although patient was terrified of the syringe, she started to use it, since the devices were not working.Even with the syringe, patient experienced a blood glucose of 578 (unit not provided).It was also reported the devices were storage on the refrigerator.Corrective treatment and outcome were not informed.Status of insulin human was unknown.Operator of devices was a family member and training status was unknown.The two humapen luxura devices were used for more than five years, and the humapen savvio was used since (b)(6) 2018.Their return is not expected.First consumer reporter stated the high blood glucose was related to the devices issue.No other opinion of relatedness was provided.Update 03may2018: additional information received on 30apr2018.Added initial reporting consumer and patient address.Updated narrative and fields appropriately.Update 04may2018: additional information received on 03may2018 and 04may2018 from a second consumer reporter and from initial reporter.Added second consumer reporter, updated the case to valid, serious case.Added insulin glargine as concomitant medication, added insulin human as suspect drug and humapen savvio as suspect device, updated humapen luxura lot number and body type and added another humapen luxura, added product complain number.Added hospitalization due to high blood glucose, added non serious event of fear of injections.Updated narrative and fields appropriately.Edit 10may2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 24may2018: additional information received on 23may2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/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 1306b02 of a humapen luxura burgundy device.Corresponding fields and narrative updated accordingly.Update 31may2018: additional information received on 25may2018 and 31may2018 from the global product complaint database were processed together.Updated the device specific safety summary (dsss) for the suspect device associated with (b)(4).Entered device specific safety summary (dsss) and updated the medwatch and european and canadian (eu/ca) device fields for the suspect device associated with (b)(4).Corresponding fields and narrative 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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 7557583
• MDR Text Key: 109742383
• Report Number: 1819470-2018-00087
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• 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
• Patient Age: 70 YR