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

Model Number MS9673A

Device Problems Mechanical Problem (1384); Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339); Mechanics Altered (2984)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

Device not returned.Usage concerns resolved, and device was reported to be working properly.A follow-up report will be submitted when the final evaluation is completed as necessary.

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, concerned a 1-year-old male patient of unknown origin.Medical history was unknown.The concomitant medications included insulin glargine administered for diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog u 100), from a cartridge, beginning on an unknown date in (b)(6) 2022 (approximately), via a reusable pen humapen luxura half-dose pen, beginning since an unknown date in (b)(6) 2022, 0.5 international units, administered four times a day, subcutaneously, for the treatment of type 1 diabetes mellitus.On an unknown date, while on insulin lispro therapy, his blood sugar dropped to 39 (units and reference range not provided).On (b)(6) 2022, the application pen malfunctioned, probably because the dose was 0.5 units, however the application pen gave a single drop instead of giving 1-2 drops and his dose was missed (lot.No, 1811g02, (b)(4)).On (b)(6) 2022, his blood sugar was 280 (units and reference range not provided).It was reported that gray area at the pressure point on the back of the application pen had become loose and the application pen might have fallen in the past.The event blood glucose decreased was considered serious due to medical significance.Further information regarding corrective treatment and outcome of events were not provided.The status of insulin lispro therapy was unknown.Follow-up was not possible as consumer did not give consent for follow-up procedures with herself and patients physician.The operator of the humapen luxura half-dose pen was patients mother and her training status was not provided.The general and suspect humapen model duration of use was approximately one month.The suspect humapen was not available for return as trouble shooting was successful.The reporting consumer did not provide relatedness of events with insulin lispro therapy and considered the events related with humapen luxura half-dose pen.Edit (b)(6) 2022: upon review of information, added a concomitant humapen luxura half dose pen to process product complaint.No other changes made to the case.Edit (b)(6) 2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit (b)(6) 2022: upon review of information, updated lot number of humapen luxura half-dose pen from unknown to 1811g02.

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 04oct2022 in the b.5.Field.This is a downgrade report that no longer meets the criteria for expedited reporting.No further follow-up is planned.Evaluation summary: the mother of the patient reported the humapen luxura hd device malfunctioned, and the device delivered "1 drop of medicine instead of 1 - 2 drops." also, the "gray part on the pressing part" had become loose.The patient experienced low blood sugar.With the guidance of a trained professional, troubleshooting was performed with the medical device (batch 1811g02, manufactured november 2018), including changing the needle, and the device primed successfully.This evaluation did not confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings regarding device broken, device not working or dose accuracy issues.A batch complaint threshold review indicted the total number of complaints received for dose accuracy issues is within the established batch threshold, and the batch is not atypical.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

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, concerned a 1-year-old male patient of unknown origin.Medical history was unknown.The concomitant medications included insulin glargine administered for diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog u 100), from a cartridge, beginning on an unknown date in jul-2022 (approximately), via a reusable pen humapen luxura half-dose pen, beginning since an unknown date jul-2022, 0.5 international units, administered four times a day, subcutaneously, for the treatment of type 1 diabetes mellitus.On an unknown date, while on insulin lispro therapy, his blood sugar dropped to 39 (units and reference range not provided).On 08-aug-2022, the application pen malfunctioned, probably because the dose was 0.5 units, however the application pen gave a single drop instead of giving 1-2 drops and his dose was missed (lot.No, 1811g02, pc no.(b)(4)).On 10-aug-2022, his blood sugar was 280 (units and reference range not provided).It was reported that gray area at the pressure point on the back of the application pen had become loose and the application pen might have fallen in the past.The event blood glucose decreased was considered serious due to medical significance.Further information regarding corrective treatment and outcome of events were not provided.The status of insulin lispro therapy was unknown.Follow-up was not possible as consumer did not give consent for follow-up procedures with herself and patients physician.The operator of the humapen luxura half-dose pen was patients mother and her training status was not provided.The general and suspect humapen model duration of use was approximately one month.The suspect humapen was not available for return as trouble shooting was successful.The reporting consumer did not provide relatedness of events with insulin lispro therapy and considered the events related with humapen luxura half-dose pen.Edit 23-aug-2022: upon review of information, added a concomitant humapen luxura half dose pen to process product complaint.No other changes made to the case.Edit 25aug2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 26-aug-2022: upon review of information, updated lot number of humapen luxura half-dose pen from unknown to 1811g02.Update 04oct2022: additional information received on 28sep2022 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no; and added the unique device identifier (udi) number, date of manufacture for the suspect humapen luxura half-dose device associated with pc (b)(4).Corresponding fields and narrative updated accordingly.

• 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: 15321764
• MDR Text Key: 298920919
• Report Number: 1819470-2022-00061
• 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,Followup
• Report Date: 10/12/2022

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: Lay User/Patient
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Device Lot Number: 1811G02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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: 12 MO
• Patient Sex: Male