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

Model Number	MS9675
Health Effect - Clinical Codes	Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Shaking/Tremors (2515)
Date of Event	03/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further follow-up is planned.Evaluation summary: a female patient reported that when using her humapen luxura hd device she did not believe she received any insulin from the injection.She also reported that she has been using the same luxura hd device for over 3 years.The patient experienced increased blood glucose.Investigation of the returned device (batch 1108g04, manufactured august 2011) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is evidence of improper use.The patient used the device beyond the recommended use period.This may not be relevant to the complaint of increased blood glucose levels.
Event or Problem Description
Lilly case id: (b)(6).This report is associated with product compliant: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a (b)(6)-year-old female patient of unknown origin.Medical history included diabetes diagnosed in 1975.Concomitant medication included insulin detemir for the treatment of type i diabetes.The patient received insulin lispro (rdna origin) injections (humalog) via reusable pen (humapen luxura hd), 12 units for the treatment of type i diabetes.Frequency, route of administration and start therapy date were not provided.On (b)(6) 2018 when she attempted to take 12 units of insulin lispro with her luxura hd pen, she did not believe she received any insulin from the injection; as a result of this missed dose her blood sugar was over 500 (no units provided) for most of the day.She felt light headed and shaky, so she called her health care professional (hcp) and was advised to take 3 units ever three hours until she got her sugar down to 300 (no units provided) and then she could eat and go back to her regular dose schedule.She followed this instruction but her sugar level did not go down and she continued to feel bad; she also tried drinking a lot of water and exercise.Since nothing was working she went to the hospital and was admitted for overnight observation.When she arrived at the hospital her blood pressure was high (no values provided) and her sodium was low (no values provided).By midnight her levels came down and by 9 am of (b)(6) 2018 (next day) they were completely regulated (it was unclear if she was referring to all levels or only to blood sugar levels).It was also reported that she used the luxura hd pen for more than three years and that it was believed that the missed dose was because the cartridge was close to be empty.Information regarding corrective treatments was not provided.She had recovered from the missed dose, of feeling light headed and shaky, the high blood sugar and the low sodium.The outcome of the remaining events was unknown.Insulin lispro treatment status was not provided.The patient was the operator of the humapen luxura hd and her training status was not provided.The general humapen luxura hd duration of use was unknown, but the suspect humapen luxura hd was used for more than three years.The humapen luxura hd was available and its return was expected.The reporting consumer assessed the events of missed dose and feeling light headed and shaky were not related to insulin lispro, that the event of high blood sugar was related and did not know if the low sodium was related.The reporting consumer did not provide an assessment of relatedness for the remaining events and assessed that the events of missed dose, feeling light headed and shaky were related to the humapen luxura hd.This case was cross-referenced to the following case: (b)(4) with the same patient.Edit (b)(6) 2018: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update (b)(6) 2018 additional information received on (b)(6) 2018 from the global product complaint database.Recoded suspect device from humapen luxura hd pen to sample humapen luxura hd pen.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, malfunction from unknown to no, and device return status to returned to manufacturer.Added date of manufacturer, date returned to manufacturer for the device, and unique identifier number (udi) for the suspect humapen luxura hd pen of (b)(6) relating to product complaint (b)(4) associated to 1108g04 lot of a sample humapen luxura hd pen.Corresponding fields and narrative updated accordingly.

• Brand Name: SAMPLE HUMAPEN LUXURA HALF-DOSE PEN
• Common Device Name: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 7477584
• Report Number: 1819470-2018-00057
• Device Sequence Number: 13536677
• Product Code: FMF
• UDI-Device Identifier: 00300029675013
• UDI-Public: 00300029675013
• Combination Product (Y/N): N
• PMA/510(K) Number: K063151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MS9675
• Device Catalogue Number: MS9675
• Device Lot Number: 1108G04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 74 YR