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

Model Number MS9662

Device Problem Break (1069)

Patient Problems Hypoglycemia (1912); Pain (1994); Dizziness (2194)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

No further follow up is planned.This report is associated with 1819470-2019-00146 and 1819470-2019-00147, since there is more than one device implicated.Evaluation summary: a female patient reported that the plunger of her humapen luxura device "isn't going in, sometimes it fails and the insulin is not injected." the patient experienced hypoglycemia.The device was not returned for investigation (batch 1207b03, manufactured july 2012).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 injection screw not moving or dose accuracy 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.There is no evidence of improper use or storage.

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 a product complaint, concerns a 70-years-old female patient of unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna), cartridge (humalog) and human insulin (rdna) not specified which type (humulin) both via reusable devices, insulin lispro three times a day and insulin human twice a day, both with unknown dosage, route of administration and indication for use, beginning on an unknown date.On an undisclosed date, unknown time after starting the insulins via humapen luxura burgundy ( lot 1207b03, product complaint (b)(4)), humapen luxura champagne (lot 1210b02, product complaint (b)(4) and humapen luxura hd (lot 1012g01, product complaint (b)(4)) ,unclear which insulin was used with which of the pens, the plunger of pen that was used with insulin lispro did not inject, it did not move.And the tip of the pen that was used with human insulin broke.It was also reported that on (b)(6) 2019, patient ended up on hospital due hypoglycemia (values not provided).The patient was doing her nails and had to run to hospital, where stayed receiving saline solution with tramadol for the treatment of pain from tight to hip that she had as a consequence of hypoglycemia.The patient was not admitted on hospital and leaved at the same day.The hypoglycemia and pain were considered serious by the company due to medically significant reasons.The pain from tight to hip improved after receiving tramadol.Further details about event or laboratories exams were not reported.Information regarding hypoglycemia event outcome was not provided.On an unspecified date, reported as when her glycaemia was under 100 (units and normal ranges not provided) the patient presented dizziness.No further information regarding those events was provided.The treatment status of insulins was unknown.The patient operated the three devices and it was unknown if she was trained.The patient has been using those device models and the reported devices since 2015 or 2016.The devices status or return status were unknown.The reporting consumer did not provide any assessment of relatedness.This case is cross-referenced with the following case: (b)(4)(same patient).Update 24jul2019: additional information received on 19jul2019 from initial reporter was processed within initial case entry.Edit 31jul2019: upon internal review on 31jul2019 of information provided on 19jul2019 added a new suspect humapen unknown device.Update 31jul2019: additional information received on 25jul2019 and 29jul2019 from initial reporter.Updated unspecified humapen suspect devices to humapen luxura burgundy, humapen luxura champagne and humapen luxura hd; added a serious event of pain; added non serious events of blood glucose under 100 and dizziness, updated the serious event of blood glucose abnormal to hypoglycemia and added information of corrective treatments.Correspondent fields and narrative were updated accordingly.Edit 01aug2019: upon internal review of information received on 29jul2019, added information of product complaints and devices lots in narrative.Update 12aug2019: additional information received on 08aug2019 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields and improper use and storage from yes to no; and added the unique device identifier (udi) number and date of manufacture for the suspect device associated with pc (b)(4).Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, and improper use and storage from yes to no; and added the date of manufacture for the suspect device associated with pc (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: 8894239
• MDR Text Key: 155498804
• Report Number: 1819470-2019-00142
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• 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: 1207B03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2012
• 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: 70 YR