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

Model Number MS9662

Device Problems Component Missing (2306); Failure to Deliver (2338)

Patient Problems Fall (1848); Headache (1880); Hearing Impairment (1881); Hemorrhage/Bleeding (1888); Hyperglycemia (1905); Visual Impairment (2138); Dizziness (2194); Injury (2348); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.Evaluation summary: a male patient reported a piece (unspecified) of his humapen luxura device was missing and the device was not delivering insulin.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number 1307b06, manufactured july 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to device not working 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 reported that he stored the device in refrigerator.The core instructions for use states to not to store the device in a refrigerator.The patient also reported he had a vision problem.The core instructions for use state that the device is not recommended for the blind or the visually impaired without the assistance of a sighted individual trained to use the device.There is evidence of improper use and storage.The patient stored the device in the refrigerator.It is unknown if this is relevant to the device not delivering insulin.The patient used the device while visually impaired.It is unknown if this is relevant to the event of increased 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 who contacted the company to report adverse events, concerns a (b)(6) years old male patient of unspecified origin.Medical history included hearing impairment and a prostatic disorder (unspecified) in 2018.Concomitant medication included gabapentin for diabetic neuropathy.The patient received insulin glargine (basaglar), daily, 20 iu, unknown route of administration and indication, beginning on an unknown date in (b)(6) 2018 or (b)(6) 2018, via humapen luxura (reported as brown/burgundy) device.On an unknown date, patients humapen luxura stopped working reported as due to the part that regulates the liquid.Upon follow up it was reported that a unspecified piece of the pen was missing (pc (b)(4)/lot 1307b06).It was also mentioned that some time ago, unknown time after starting insulin glargine, patient experienced a retinal bleeding.It was also reporter that patient had a vision problem for a while and patient's doctor reported that every time his diabetes increased from 400 to 450 his eye would get worse; also, that your glycemia stays around 300, 400, 450 (no units provided).These events were considered serious by the company due to their medical significance.A retinal surgery was schedule for (b)(6) 2019.It was also reported that patient's problem was in the head, like a pressure and dizziness.On an unknown date the patient fell, cut his tongue and his hearing impairment worsened.Patient also did not feel his hands and his feet.Lastly, it was reported that patient always stored the device inside the refrigerator, wrapped in a paper so that it did not freeze (as reported).It was also informed that the insulin remained always inside the device, therefore, inside the refrigerator as well.No information regarding corrective treatment, events outcome or therapy status was provided.The patient operated the device and it was unknown if he was trained.The general device use length was not provided.The suspect device duration of use was reported as since 2016 or 2017 (unspecified); two or three years.The suspect device, which was manufactured in jul2013, was not returned to the manufacturer.No relatedness opinion was provided regarding the events and the drug.Update 17apr2019: source documents from 12apr2019 and 15apr2019 were processed as initial case.Edit 18apr2019: patient's country was updated.No other change was performed.Update 23apr2019: additional information was received on 16apr2019 from the initial reporter via call center.Added reporters alternate phone number; added non-serious event of product storage error.Updated devices improper use or storage from no to yes.Narrative and corresponding fields were updated accordingly.Edit 25apr2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Update 03may2019: additional information received on 01may2019 from the global product complaint database.Recoded the suspect device from humapen luxura unknown body type to a humapen luxura (burgundy) device.Entered device specific safety summary (dsss).Updated the medwatch/european and (b)(4) (eu/(b)(4)) device information and device return status to not returned to manufacturer.Added date of manufacturer for pc (b)(4) associated with lot 1307b06 associated with humapen luxura device.Corresponding fields and narrative updated accordingly.Upon internal review, updated device age field from unknown to 3 years.

• Brand Name: HP 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: 8592846
• MDR Text Key: 144667257
• Report Number: 1819470-2019-00081
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Device Lot Number: 1307B06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 80 YR