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); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

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, concerned a female patient of unknown age and origin.Medical history included type 1 diabetes mellitus.The concomitant medication were not provided.The patient received insulin lispro (rdna origin) injections (humalog), from a cartridge, beginning since an unknown date, via a reusable pen humapen luxura half dose pen, beginning since an unknown date.Dosage regimen, route of administration, therapy start dates and indication of use were unknown.On an unspecified date in jan-2023, she was hospitalized for ten days due to diabetes and she was sick with fever.Since an unknown date, while administering insulin lispro, her application pen was defective, when she tried to apply one or two drops came from the pen and since (b)(6) 2023, her blood sugar rose to 350-400 (units and reference range not provided) for three days.On (b)(6) 2023, her blood glucose increased, and it was not like previous.She reported her blood glucose did not increase like that normally and she checked if there was a problem with the application pen.She reported, when she wanted to apply insulin, one, four or five drops would come instead medication should have come like water (in large quantities) (lot unknown, (b)(4).It was reported as of (b)(6) 2023, she was recently discharged from hospital (specific dates not provided).Information regarding corrective treatment, hospitalization details and outcome of events were unknown.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 her physician.Patient was the operator of humapen luxura and her training status was not provided.The general humapen luxura model and suspect humapen luxura model duration was of use was unknown.The action taken with humapen, and its return status were unknown.The reporting consumer did not provide relatedness of events with insulin lispro or humapen luxura.Update (b)(6) 2023: information received from affiliate o (b)(6) 2023.No medically significant information recieved.Pc number was provided and processed accordingly.Edit (b)(6) 2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.Added udi number (b)(4).No new information added.

Manufacturer Narrative

B.5.Narrative field: new, updated, and corrected information is referenced within the update statement in b.5.Please refer to update statement dated 03mar2023 in the b.5.Field.No further follow-up is planned.Evaluation summary the mother of a diabetic patient reported that the patient's humapen luxura hd device "was defective, when she tried to apply one or two drops came from the pen." she also stated when she "adjusted the pen as 1.5 iu, only 4 drops of medicine came out" and "normally the medication should have come like water [in large quantities]." 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.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 female patient of unknown age and origin.Medical history included type 1 diabetes mellitus.The concomitant medication were not provided.The patient received insulin lispro (rdna origin) injections (humalog), from a cartridge, beginning since an unknown date, via a reusable pen humapen luxura half dose pen, beginning since an unknown date.Dosage regimen, route of administration, therapy start dates and indication of use were unknown.On an unspecified date in (b)(6) 2023, she was hospitalized for ten days due to diabetes and she was sick with fever.Since an unknown date, while administering insulin lispro, her application pen was defective, when she tried to apply one or two drops came from the pen and since (b)(6) 2023, her blood sugar rose to 350-400 (units and reference range not provided) for three days.On (b)(6) 2023, her blood glucose increased, and it was not like previous.She reported her blood glucose did not increase like that normally and she checked if there was a problem with the application pen.She reported, when she wanted to apply insulin, one, four or five drops would come instead medication should have come like water (in large quantities) (lot unknown, (b)(4)).It was reported as of (b)(6) 2023, she was recently discharged from hospital (specific dates not provided).Information regarding corrective treatment, hospitalization details and outcome of events were unknown.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 her physician.Patient was the operator of humapen luxura and her training status was not provided.The general humapen luxura model and suspect humapen luxura model duration of use was unknown.The suspect humapen luxura half dose device was not returned to manufacturer for investigation.The reporting consumer did not provide relatedness of events with insulin lispro or humapen luxura.Update 16-feb-2023: information received from affiliate on 13-feb-2023.No medically significant information recieved.Pc number was provided and processed accordingly.Edit 17feb2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.Added udi number (b)(4).No new information added.Update 03mar2023: additional information received on 01mar2023 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information.The humapen luxura half-dose was not returned to manufacturer for investigation.Corresponding fields and narrative updated accordingly.

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 female patient of unknown age and origin.Medical history included type 1 diabetes mellitus.The concomitant medication were not provided.The patient received insulin lispro (rdna origin) injections (humalog), from a cartridge, beginning since an unknown date, via a reusable pen humapen luxura half dose pen, beginning since an unknown date.Dosage regimen, route of administration, therapy start dates and indication of use were unknown.On an unspecified date in (b)(6) 2023, she was hospitalized for ten days due to diabetes and she was sick with fever.Since an unknown date, while administering insulin lispro, her application pen was defective, when she tried to apply one or two drops came from the pen and since (b)(6) 2023, her blood sugar rose to 350-400 (units and reference range not provided) for three days.On (b)(6) 2023, her blood glucose increased, and it was not like previous.She reported her blood glucose did not increase like that normally and she checked if there was a problem with the application pen.She reported, when she wanted to apply insulin, one, four or five drops would come instead medication should have come like water (in large quantities) (lot unknown, pc (b)(4)).It was reported as of (b)(6) 2023, she was recently discharged from hospital (specific dates not provided).Information regarding corrective treatment, hospitalization details and outcome of events were unknown.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 her physician.Patient was the operator of humapen luxura and her training status was not provided.The general humapen luxura model and suspect humapen luxura model duration of use was unknown.The suspect humapen luxura half dose device was not returned to manufacturer for investigation.The reporting consumer did not provide relatedness of events with insulin lispro or humapen luxura.Update 16-feb-2023: information received from affiliate 13-feb-2023.No medically significant information received.Pc number was provided and processed accordingly.Edit 17feb2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.Added udi number (b)(4).No new information added.Update 03mar2023: additional information received on 01mar2023 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information.The humapen luxura half-dose was not returned to manufacturer for investigation.Corresponding fields and narrative updated accordingly.Update 16mar2023: upon internal review from information received 01mar2023, updated medical device component code from 1384 mechanical problem to 2182 insufficient flow or under infusion.Corresponding fields updated.

• 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: 16432683
• MDR Text Key: 310127511
• Report Number: 1819470-2023-00012
• 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,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female