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

Model Number MS9673A

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

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a(b)(6) female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog unspecified type) from cartridge, via a reusable pen (humapen, luxura half-dose), at dose of 09 international units, subcutaneously, for treatment of diabetes mellitus, beginning on (b)(6) 2012.On an unknown date, after starting insulin lispro therapy, she had high blood glucose level.On evening of (b)(6) 2022, she was hospitalized due to high blood glucose level (exact values, units and reference range were not provided).Her blood glucose elevated to around 300 (exact values, units and reference range were not provided) and hemoglobin a1c to around 16 (exact values, units and reference ranges were not provided).On (b)(6) 2022, her blood glucose was over 200 (exact value, units and reference range were not provided).On 22-feb-2022, as per her doctor these values would be recovered.Further information regarding hospitalization was not provided.Outcome of the event blood glucose increased was recovering while outcome of event hemoglobin a1c increased was not provided.Insulin lispro therapy was continued.No follow up would be attempted as consumer did not give consent to contact for herself and the doctor of patient for follow up procedures.The operator of the humapen luxura hd was the unknown and his/her training status was not provided.The humapen luxura hd general model duration of use and the suspect humapen luxura hd device duration of use were approximately 121 months.Action taken with the suspect humapen luxura hd was not provided and its return was not expected since there was no issue with it.The initial reporting consumer did not provide relatedness assessment of the events with insulin lispro drug and suspect humapen luxura hd device.Update 01mar2022: additional information received on 01mar2022.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; added the unique device identifier (udi) number.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

New updated and corrected information is referenced within the update statements.Please refer to statement dated 01mar2022.No further follow up is planned.Evaluation summary: the reporter stated the patient used the humapen luxura half dose (hd) for approximately ten years.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 hd for approximately ten years.The humapen luxura hd user manual states to not use the pen for more than three years after the first use.

• 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; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 13721001
• MDR Text Key: 287276127
• Report Number: 1819470-2022-00020
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2022
• 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: 17 YR
• Patient Sex: Female