MAUDE Adverse Event Report: ELI LILLY AND COMPANY HP LUXURA, UNKNOWN PEN BODY TYPE; FOR TREATMENT PURPOSES

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Hyperglycemia (1905); Myalgia (2238); Test Result (2695)

Event Type  Injury  

Manufacturer Narrative

There was no reported complaint for this device and its return is not expected.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: pending.This spontaneous case, reported by a consumer, who contacted the company to ask for information, concerns an adult female patient of unknown age and origin.Medical history was not provided.Concomitant medication included: insulin glargine for unknown indication for use.The patient received human insulin (rdna origin) regular (unknown manufacturer), via humapen luxura, unknown body type, 2 iu, when the patient s glycemia was high, unknown route of administration, for type 1 diabetes mellitus, starting in the beginning of 2018.On an unspecified date, unknown time after beginning human insulin, the patient experienced muscular pain in shoulders.She underwent red blood cell sedimentation rate test, which was altered (no values provided), the patient s rheumatoid factor was at 16 (reference range: up to 8; no unit was provided) and she underwent a shoulder ultrasound, which was normal.On unknown date, the patient was diagnosed with arthritis.As corrective treatment, the patient received unspecified antibiotic, ketorolac tromethamine and metamizole sodium.It was also reported that the patient was experiencing difficulty to control her glycemia.On unspecified date, the patient s glycemia was between 270 and 290 (no unit and reference range provided).Due to these events, the patient was hospitalized on (b)(6) 2018.To control the patient's glycemia, the dose of insulin glargine was gradually increased to 60 iu, 70 iu and 80 iu, which was ongoing.Also, when the patient s glycemia exceeded 300, the human insulin r dose was 8 iu daily and if the glycemia was under 300 the dose was 6 iu.The patient also was prescribed metformin as corrective treatment.The patient was discharged from hospital on (b)(6) 2019.The patient s glycemia was more controlled (fasting blood glucose was between 140 and 156 and after lunch it was 190) and the pain in shoulders ceased.Information regarding laboratorial examination, corrective treatments and event outcome was not provided.The human insulin regular therapy status was not provided.Who was the operator of the device and the training status was not provided.This device model and the reported device have been used for unknown period of time (reported to be expired).The device was not expected to return since there was no associated product complaint.The reporting consumer did not provide an opinion of relatedness.Edit (b)(6) 2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

• Brand Name: HP LUXURA, UNKNOWN PEN BODY TYPE
• 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: 8311257
• MDR Text Key: 135351011
• Report Number: 1819470-2019-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: No
• 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