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

Model Number MS9673A

Device Problems Inaccurate Delivery (2339); Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.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 complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 3-year-old female patient of an unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog 100u/ml), reusable humapen luxura half-dose pen, 6 units -9 units depends on meals, subcutaneously, for the treatment of diabetes beginning in (b)(6) 2023.On an unknown date, while on insulin lispro, the device did not release accurate dose because there was disturbance in blood glucose level, on (b)(6) 2023, she had blood glucose level elevated from 3 days in morning, despite of taking her insulin dose.Also, the blood glucose level was decreased in night which reached 30-35mg/dl.This events was considered to be serious by the company due to its medical significance.It was performed a (glycated haemoglobin) hba1c lab test on (b)(6) 2023, and its result was 5.9mg/dl, as per the physician it was normal range.She was recovering, but she used to suffer from disturbance in blood glucose level frequently as it was happened before in (b)(6) 2023 upon starting insulin lispro.The device might not release medication because 1 or 2 drops of insulin could be observed on the needle after dose administration, but sometimes else, no insulin drops were existed.((b)(6); lot number: unknown).Insulin lispro treatment status was ongoing with no change.Information regarding corrective treatments was not provided.The operator of the humapen luxura half-dose pen was unknown, and his/her training status was not provided.The general humapen luxura half-dose pen model duration of use and suspect humapen luxura half-dose pen duration was not reported.The action taken with the suspect humapen luxura half-dose pen was no unknown and its return was not expected.The initial reporting consumer did not relate the events with insulin lispro drug but related with humapen luxura half-dose pen.Update 18jul2023: information received from the rcp reading pc number (b)(6).The same was processed in catool and updated in narrative.No new significant information received and no further changes were done in he case.Edit 18jul2023: updated medwatch fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 3-year-old female patient of an unknown ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) injections (humalog 100u/ml) cartridge via reusable humapen luxura half-dose pen, 6 units -9 units depends on meals, subcutaneously, for the treatment of diabetes beginning in (b)(6) 2023.On an unknown date, while on insulin lispro, the device did not release accurate dose because there was disturbance in blood glucose level, on (b)(6) 2023, she had blood glucose level elevated from 3 days in morning, despite of taking her insulin dose.Also, the blood glucose level was decreased in night which reached 30-35mg/dl.This events was considered to be serious by the company due to its medical significance.It was performed a (glycated haemoglobin) hba1c lab test on (b)(6) 2023, and its result was 5.9mg/dl, as per the physician it was normal range.She was recovering, but she used to suffer from disturbance in blood glucose level frequently as it was happened before in (b)(6) 2023 upon starting insulin lispro.The device might not release medication because 1 or 2 drops of insulin could be observed on the needle after dose administration, but sometimes else, no insulin drops were existed.(pc (b)(4); lot number: unknown).It was reported that user was storing the device in the refrigerator with the needle attached (improper use or storage).Insulin lispro treatment status was ongoing with no change.Information regarding corrective treatments was not provided.The operator of the humapen luxura half-dose pen was unknown, and his/her training status was not provided.The general humapen luxura half-dose pen model duration of use and suspect humapen luxura half-dose pen duration was not reported.The action taken with the suspect humapen luxura half-dose pen was no unknown and device was not returned to manufacturer.The initial reporting consumer did not relate the events with insulin lispro drug but related with humapen luxura half-dose pen.Update 18jul2023: information received from the rcp reading pc number (b)(4).The same was processed in catool and updated in narrative.No new significant information received and no further changes were done in he case.Edit 18jul2023: updated medwatch fields for expedited device reporting.No new information added.Edit 21-jul-2023: upon review of initial information.Updated humappen luxurahd model item code ms9673a instead of ms9673.Update 22aug2023: additional information received on 16aug2023 from the global product complaint database.Entered the device specific safety summary (dsss) for humapen luxura half-dose pen associated with (b)(4), lot number: unknown.Updated the medwatch, european and canadian (eu/ca), updated improper use or storage from no to yes, device return status to not returned to manufacturer.Unique device identifier (udi) for the suspect humapen luxura half-dose pen device associated with (b)(4) was updated.In addition upon internal review, drug formulation of insulin lispro was updated from unknown to cartridge.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement(s) dated 22aug2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: a consumer reported on behalf of a female patient reported that her humapen luxura hd device did not release accurate dose of insulin, and the "device might not release medication because 1 or 2 drops of insulin could be observed on the needle after dose administration, but sometimes else, no insulin drops were existed." the patient experienced decreased blood glucose.The device was not returned to the manufacturer for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The user reported storing the device in the refrigerator with the needle attached.The core instructions for use state to use a new needle for each injection, to remove the needle after every use, to not store the pen with the needle attached, and to not to store the device in a refrigerator.There is evidence of improper use.The user stored the device in the refrigerator with the needle attached.It is unknown if these misuses are relevant to the event of decreased blood glucose.These misuses may be relevant to the complaint that "1 or 2 drops of insulin could be observed on the needle after dose administration, but sometimes else, no insulin drops were existed.".

• 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: catherine cassidy ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 17350922
• MDR Text Key: 319306911
• Report Number: 1819470-2023-00049
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• 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: 08/16/2023
• 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): Other
• Patient Age: 3 YR
• Patient Sex: Female