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

Model Number MS9673A

Device Problems Inaccurate Delivery (2339); Mechanical Jam (2983); Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Date 12/31/2023

Event Type  Injury  

Manufacturer Narrative

Since the device sis not being returned, evaluation for a malfunction is not possible.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

Lilly case id: (b)(6).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to report an adverse events and product complaint, concerned a 12-years old female patient of unknown origin.Medical history was not provided.The concomitant medication included insulin degludec administered for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) through a cartridge administered thrice daily, 12 units, 10 units, and 12 units, subcutaneously for the treatment of diabetes, via humapen luxura hd, beginning on an unknown date in 2015.On an unknown date, while on insulin lispro treatment, the humapen luxura hd needed high injection force during administration and did not release accurate insulin lispro doses which led to elevation in blood glucose level (pc number, (b)(4); lot number, 1201g07).On unspecified date in (b)(6) 2023, it was reported when she administered full dose units, she suffered from hypoglycemic coma as her blood glucose level decreased around 100mg/dl from the total blood glucose level, with symptoms of vomiting and loss of consciousness from two to three weeks.The event hypoglycemic coma was considered serious by the company due to medical significance.While administering insulin lispro, she possibly used the same humapen luxura hd pen since 2015 (improper use).Corrective treatment involved glucagon administered for hypoglycemic coma and information regarding corrective treatment of remaining events were not provided.Outcome of incorrect dose administered and blood glucose increased was unknown and outcome of remaining events was resolved.The status of insulin lispro therapy was continued.The operator of the humapen luxura hd was unknown and his/her training status was unknown.The device model duration of use was not reported, and the suspect humapen luxura hd duration of use was eight years approximately.Troubleshooting was conducted and failed.The suspect humapen luxura hd was not available for return as device retrieval was refused from the reporter but she requested device replacement.The reporting consumer did not provide relatedness for the event incorrect dose administered and did not relate the remaining events with insulin lispro drug.However, did not provide relatedness for the event incorrect dose administered and related the remaining events with humapen luxura hd.Update 28-aug-2023: no new medically significant information received on 24-aug-2023 via affiliate.Pc number received processed accordingly and no new information added to the case.Update 21-dec-2023: additional information was received from initial reporter on 18-dec-2023.Added age of patient.Added one concomitant drug; insulin degludec and one treatment drug; glucagon.The case was upgraded to serious upon addition of one serious event of hypoglycemic coma.Added laboratory data test.Updated lot number of insulin lispro drug from unknown to d479810a and for humapen luxura hd from unknown to 1201g07.Updated narrative accordingly.Update 22dec2023: additional information received on 20dec2023 from global product complaint database reiterated the lot number 1201g07 which was already present and correct in the case.Update 04-jan-2024: information was received from affiliate on 27-dec-2023.Since the reporter contacted the physician though health insurance hospital, so no contact number was available.No new medically significant information was reported, hence no changes were made to the case.Edit 11jan2024: updated medwatch and european and canadian (eu/ca) 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 spontaneous case, reported by a consumer, who contacted the company to report an adverse events and product complaint, concerned a 12-years old female patient of unknown origin.Medical history was not provided.The concomitant medication included insulin degludec administered for unknown indication.The patient received insulin lispro (rdna origin) injections (humalog) through a cartridge administered thrice daily, 12 units, 10 units, and 12 units, subcutaneously for the treatment of diabetes, via humapen luxura hd, beginning on an unknown date in 2015.On an unknown date, while on insulin lispro treatment, the humapen luxura hd needed high injection force during administration and did not release accurate insulin lispro doses which led to elevation in blood glucose level (pc number, (b)(4); lot number, 1201g07).On unspecified date in dec-2023, it was reported when she administered full dose units, she suffered from hypoglycemic coma as her blood glucose level decreased around 100mg/dl from the total blood glucose level, with symptoms of vomiting and loss of consciousness from two to three weeks.The event hypoglycemic coma was considered serious by the company due to medical significance.While administering insulin lispro, she possibly used the same humapen luxura hd pen since 2015, stored the pen in the refrigerator, and it was noted that the patient took full dose units instead of half units (considered improper use and storage).Corrective treatment involved glucagon administered for hypoglycemic coma and information regarding corrective treatment of remaining events were not provided.Outcome of incorrect dose administered and blood glucose increased was unknown and outcome of remaining events was resolved.The status of insulin lispro therapy was continued.The operator of the humapen luxura hd was unknown and his/her training status was unknown.The device model duration of use was not reported, and the suspect humapen luxura hd duration of use was eight years approximately.Troubleshooting was conducted and failed.The suspect humapen luxura hd was not available for return as device retrieval was refused from the reporter but she requested device replacement.The reporting consumer did not provide relatedness for the event incorrect dose administered and did not relate the remaining events with insulin lispro drug.However, did not provide relatedness for the event incorrect dose administered and related the remaining events with humapen luxura hd.Update 28-aug-2023: no new medically significant information received on 24-aug-2023 via affiliate.Pc number received processed accordingly and no new information added to the case.Update 21-dec-2023: additional information was received from initial reporter on 18-dec-2023.Added age of patient.Added one concomitant drug; insulin degludec and one treatment drug; glucagon.The case was upgraded to serious upon addition of one serious event of hypoglycemic coma.Added laboratory data test.Updated lot number of insulin lispro drug from unknown to d479810a and for humapen luxura hd from unknown to 1201g07.Updated narrative accordingly.Update 22dec2023: additional information received on 20dec2023 from global product complaint database reiterated the lot number 1201g07 which was already present and correct in the case.Update 04-jan-2024: information was received from affiliate on 27-dec-2023.Since the reporter contacted the physician though health insurance hospital, so no contact number was available.No new medically significant information was reported, hence no changes were made to the case.Edit 11jan2024: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 19jan2024: additional information received on 16jan2024 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch device fields and ius; added date of manufacture for the suspect humapen luxura half-dose device associated with (b)(4).Corresponding fields and narrative updated accordingly.Update 30jan2024: additional information received on 25jan2024 from the global product complaint database.Updated the device specific safety summary (dsss) for the suspect humapen luxura half-dose device associated with (b)(4).Corresponding fields and narrative updated accordingly.Update 02-feb-2024: information was received from initial reporter on 31-jan-2024.No new medically significant information was reported, hence no changes were made to the case.

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 30jan2024 in the b.5.Field.No further follow-up is planned.Evaluation summary a consumer reported on behalf of a female patient that on an unknown date her humapen luxura hd had high injection force during administration and did not release accurate insulin.In december 2023, the patient took full dose units (not half units).The patient experienced a serious adverse event of hypoglycemic coma and non-serious adverse events of increased blood glucose and incorrect dose administration.The device was not returned to the manufacturer for investigation (batch number 1201g07, manufactured january 2012).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 and dose accuracy with high probability.A complaint history review did not identify any atypical findings with regard to high injection force issues.A batch complaint threshold review indicated the total number of complaints received for dose accuracy issues is within the established batch threshold and the batch is not atypical.The patient used the device since 2015, approximately 8 years.The core instructions for use states the humapen luxura hd has been designed to be used for up to 3 years after first use.The reporter stated that the device was stored in the refrigerator.The core instructions for use states to not to store the device in a refrigerator.There is evidence of improper use and storage.The patient used the device beyond the recommended use period and the device was stored in the refrigerator.It is unknown if these misuses are relevant to the event of hypoglycemic coma.

• 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 ; 3174332191
• MDR Report Key: 18527520
• MDR Text Key: 333048295
• Report Number: 1819470-2023-00085
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Lot Number: 1201G07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2012
• 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 YR
• Patient Sex: Female