MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problems Break (1069); Failure to Deliver (2338)

Patient Problem Complaint, Ill-Defined (2331)

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 26jun2019.No further follow-up is planned.Evaluation summary: a consumer reported on behalf of a male patient that when the injection button is pulled using the patient's humapen luxura hd device it does not go, and when the injection is complete, the dose marker is not lined up with the zero.Therefore, it was believed that the correct dose was not injected.The patient experienced inadequate diabetes control.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 hd 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

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company due to obtain an information, concerns a pediatric male patient of unknown ethnicity.Medical history included type 1 diabetes diagnosed in 2016.Concomitant medications included insulin degludecfor type 1 diabetes.The patient received human insulin (rdna origin) nph (unknown manufacturer) for type 1 diabetes, unknown dose, frequency, route of administration and start date.It was unknown how the insulin nph was administered.In 2017, he started receiving insulin lispro (humalog) for type 1 diabetes, unknown dose, frequency and route of administration.The drug was administered via humapen luxura half-dose pen, however it was unknown if it was injected via this pen since the treatment beginning.On an unknown date, unclear after which of the insulins, the patient was hospitalized due to type 1 diabetes, also reported as the patient was hospitalized because anyone could provide everything the patient needed in his treatment.Furthermore, it was reported that the patient was hospitalized for the same reason several times (the reporter believes he was hospitalized five times) and that the hospitalizations occurred since his diagnosis in 2016.During one of the hospitalizations, the patient received a humapen luxura half-dose pen and at the time of this initial report it was old and the case was broken.When the button is pulled, it is not elevated and the 0 did not stay in the red set after injection, therefore, it was believed that the correct dose was not injected (lot number: unknown, product complaint: (b)(4)).In one of the hospitalizations, the patient had to be intubated which was considered life threatening by the company.In (b)(6) 2019, he was hospitalized again due to diabetes.Information regarding relevant lab data, corrective treatments, outcome and discharge dates were not provided.It was unknown who was the device operator at the time of the hospitalization, but the patient aunt was the operator at the time of the report.It was unknown if they were trained.They had used this device model and the reported device for unknown time.It was unknown if the device would be returned.No relatedness opinion was provided regarding the events and human insulin nph and insulin lispro.Update 12jun2019: additional information received on 07jun2019 was processed within initial case entry.Edit 13jun2019: upon internal review, case was unlocked to amend some typos in case narrative.Edit 18jun2019: upon internal review, case was unlocked to update the event coding from type 1 diabetes mellitus to diabetes mellitus inadequate control, the as reported and narrative were also updated to clarify that the patient already have diabetes as diagnosis.Also, insulin human as reported and as determined causality of the correct dose is not injected due to the pen issue was updated to not associated and listedness for this drug was filled.Edit 19jun2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Edit 21jun2019: upon internal review of information received on 06jun2019, recoded the humapen luxura hd (specific model number ms9673 to ms9673a) based on the unknown device lot number.Edit 21jun2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting.No new information added.Update 26jun2019: additional information received on 26jun2019 from the global product complaint database.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 pc (b)(4) associated with lot unknown relating to humapen luxura hd device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• 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; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 8761133
• MDR Text Key: 150142429
• Report Number: 1819470-2019-00117
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• 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; Life Threatening