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

Model Number MS9662

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

No further follow up is planned.Evaluation summary: the reporter stated the patient used the humapen luxura burgundy since 2009 and ongoing.There was no product complaint for the device and the device was not returned for investigation.There was evidence of improper use of the device.The patient used the humapen luxura burgundy for approximately ten years.The humapen luxura burgundy user manual states to not use the pen for more than six years after the first use.

Event Description

Hold for jordan 4.6 lilly case id: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaints (pc), concerned an asian (b)(6)-years old male patient of (b)(6).Medical history included sulfonamides allergy.Concomitant medication included metformin for an unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25, 100u/ml), via a reusable humapen luxura unknown body type device and a humapen luxura burgundy (red, metal), twice daily (21 in morning, 21 in night) and also provided as (22-24 units in morning and night), subcutaneously, for the treatment of diabetes mellitus, beginning sometime in 2008 or 2009 (conflicting information was provided by the reporter).On an unspecified date in 2015, two humapen luxura (unknown body type) used since 2009 (as of (b)(6) 2019 still in use) did not work properly (lot numbers unknown / pcs (b)(4)); the button for injection was loose.The use of humapen luxura burgundy since 2009 was considered to be an improper use.On unknown date, during insulin lispro protamine suspension 75%/insulin lispro 25%, his blood sugar was increased; therefore, he was hospitalized on unknown date.Since an unknown date from sometime in (b)(6) 2019, his eyes could not see clearly and it was a little blurred and a little fuzzy.Information regarding any corrective treatment was not provided.He had not recovered from the blurred vision event while the remaining event outcome was not reported.Insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of the humapen luxura unknown body type and humapen luxura burgundy and his/ her training status were not provided.The general humapen luxura unknown body type and humapen luxura burgundy devices duration of uses were not provided.Suspects humapen luxura unknown body type devices was approximately 11 years as it was started in 2008 and humapen luxura burgundy devices durations of use was approximately 10 years as it was started in 2009.The use of humapen luxura unknown body type devices was continued and their return was not expected while the use of humapen luxura burgundy was continued and its return status was not provided.The reporting consumer was not sure if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% treatment and did not provide the relatedness opinion between the events and humapen luxura unknown body type and humapen luxura burgundy devices.Update 21-jan-2019: both information received on 17-jan-2019 was processed at the same time.Edit 24-jan-2019: upon review of the information received on 17-jan-2019, the case was re-opened to correct the initial receipt date in narrative.No other changes were made in the case.Edit 01feb2019: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Edit 12-feb-2019: upon review of the initial information and information provided via product complaints (pcs) received on the same date: deleted suspect humapen unknown type.Updated humapen luxura devices to suspect and description to humapen luxura unknown type.Product complaints were reprocessed accordingly.Narrative was updated.Edit 13-feb-2019: upon review of the initial information: updated improper use field for both suspect devices.Updated insulin lispro start date narrative was updated accordingly.Edit 14feb2019: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 22-feb-2019: additional information received on 21-feb-2019 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch/european and (b)(6) (eu/(b)(6)) device information, malfunction from unknown to no, and device return status to not returned to manufacturer for pc (b)(4) and (b)(4) associated with unknown lot numbers of humapen luxura (unknown body type) devices.Corresponding fields and narrative updated accordingly.Upon review, updated device age field from unknown to 11 years.Update 06-dec-2019: additional information received on 04-dec-2019 from the initial reporter via psp.Added; a suspect humapen luxura burgundy device, a non-serious event of blurred vision and a new dosage regimen for insulin lispro 25/75 treatment.Added; ethnicity of patient.Pc# 4971277 was received for humapen luxura burgundy and was rejected with type-ii reason.Updated reported indication for insulin lispro 25/75 as diabetes mellitus, action taken as ongoing, causality statement, device paragraph and narrative with new information.Edit 12dec2019: updated medwatch fields for expedited device reporting.No new information added.Update 23dec2019: entered a device specific safety summary (dsss) for the humapen luxura burgundy.Updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.Corresponding fields and narrative updated accordingly.

• 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: 9512459
• MDR Text Key: 186602580
• Report Number: 1819470-2019-00226
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 0901B02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/23/2019
• 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
• Patient Age: 53 YR
• Patient Weight: 71