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

Model Number MS9673A

Device Problems Defective Device (2588); Mechanical Jam (2983); Device Fell (4014)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 01/31/2021

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.This report is associated with 1819470-2022-00045 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaints (pc), concerns a female patient of an unknown age and origin.Medical history included diabetes.The concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from a cartridge via a reusable device (humapen luxura hd) for the treatment of diabetes mellitus, beginning on an unknown date.Information regarding dose, frequency and route of administration was not provided.On an unknown date in 2021, she had low blood glucose level (units, values and reference range not provided).She normally could wait up to half an hour before food before using the insulin; however, by the time she got to the fridge to take her insulin out, she was unconscious.It took the ambulance three hours to revive her.She informed this was due to low blood glucose level and they stuffed glucose in her mouth.She also reported that she has saw her endocrinologist frequently for many years who advised that she may need to have a few units of insulin at night, depending on her blood glucose level.She usually woke up after midnight and would check her blood glucose level then.If needed, she would give herself insulin.She reported that she once had a box of humulin 30/70 cartridges which did not work for her (lot.No, unknown, pc.No.5994184).It was useless did not do anything and did not control anything.She then discarded them and obtained a new batch.She did not think it was due to any storage issues.She also experienced neuropathy and her eyes were not very good because of diabetes.She reported that first luxura hd pen she had, which she used for several years, since an unknown date, got stuck (pc number (b)(4), lot number 1610g01) and her current luxura hd pen was sent as replacement.While administering human insulin isophane suspension 70%/human insulin 30%, her eyes were not very good due to diabetes (improper use).On (b)(6) 2022, she dropped her second humapen onto the kitchen floors solid tile and her pen got stuck and the screw that pressed onto the cartridge broke and detached from the pen (pc number (b)(4), lot number 1610g01).She kept the pen-cartridge combination in the fridge (improper use).The events loss of consciousness and blood glucose decreased were considered serious due to medical significance.Information regarding corrective treatment and outcome of the events was not provided.Status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided.The operator of the humapen luxura half-dose pens was the patient, and her training status was not provided.The general humapen luxura half-dose pen model duration of use and the suspect humapen luxura half-dose pen duration of use was unknown.The action taken with the humapen luxura half-dose pen was unknown and its return was expected.The reporting consumer related the event of lack of drug effect with human insulin isophane suspension 70%/human insulin 30% drug while did not provide the relatedness assessment between the rest of events and human insulin isophane suspension 70%/human insulin 30% drug and suspect humapen luxura hd device.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 narrative date for reported pc for humapen luxura hd lot no 1610g01, updated product complaint description for humapen luxura hd lot no unknown, updated improper use and storage for both humapen luxura hd devices to yes.Updated narrative accordingly.Update (b)(6) 2022: additional information received on (b)(6) 2022 from global product complaint database.Updated the lot number from unknown to 1610g01 for product complaint (b)(4) related to the humapen luxura half-dose pen.Recoded both suspect devices from humapen luxura half-dose pen (model number ms9673a) to humapen luxura half-dose pen (model number ms9673).Narrative and corresponding field was updated accordingly.Edit (b)(6) 2022: recoded both suspect devices from humapen luxura half-dose pen (model number ms9673) to humapen luxura half-dose pen (model number ms9673a).No other information was updated.

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 09aug2022 in the b.5.Field.No further follow-up is planned.This report is associated with 1819470-2022-00045 since there is more than one device implicated.Evaluation summary a female patient reported that she dropped her humapen luxura hd device onto the solid tile floor, and her pen got stuck and the injection screw broke and detached from the pen.On an unknown date in 2021, she experienced decreased blood glucose and loss of consciousness.Investigation of the returned device (batch number 1610g01, manufactured october 2016) found the injection screw was broken and there was damage on the foot of the injection screw.The damage occurred in the field, as this type of damage would have been detected during the manufacturing inspection process.Due to the field damage, a functional assessment could not be performed.Malfunction confirmed.In addition, the pylons of the injection nut were observed to be damaged, and a glass particle was observed in the front housing area of the device.Glass particles and damaged pylons indicate excessive force was applied when inserting a cartridge causing the cartridge to break inside the front housing.This damage occurred in the field and is not related to the manufacturing process.The core instruction for use provides adequate care and storage instructions, instructs to not use the device if it appears broken or damaged, and to contact lilly or a healthcare provider for a replacement pen.The patient reported that she stored the device in the refrigerator.The core instructions for use states to not to store the device in a refrigerator.The patient also reported her eyes were not very good due to diabetes.The core instructions for use state that the device is not recommended for the blind or the visually impaired without the assistance of a sighted individual trained to use the device.There is evidence of improper use and storage.The patient stored the device in the refrigerator and used the device while visually impaired.It is unknown if these are relevant to the events of decreased blood glucose and loss of consciousness.This report is associated with 1819470-2022-00045 since there is more than one device implicated.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaints (pc), concerns a female patient of an unknown age and origin.Medical history included diabetes.The concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from a cartridge via a reusable device (humapen luxura hd) for the treatment of diabetes mellitus, beginning on an unknown date.Information regarding dose, frequency and route of administration was not provided.On an unknown date in 2021, she had low blood glucose level (units, values and reference range not provided).She normally could wait up to half an hour before food before using the insulin; however, by the time she got to the fridge to take her insulin out, she was unconscious.It took the ambulance three hours to revive her.She informed this was due to low blood glucose level and they stuffed glucose in her mouth.She also reported that she has saw her endocrinologist frequently for many years who advised that she may need to have a few units of insulin at night, depending on her blood glucose level.She usually woke up after midnight and would check her blood glucose level then.If needed, she would give herself insulin.She reported that she once had a box of humulin 30/70 cartridges which did not work for her (lot.No: unknown, pc.No.5994184).It was useless did not do anything and did not control anything.She then discarded them and obtained a new batch.She did not think it was due to any storage issues.She also experienced neuropathy and her eyes were not very good because of diabetes.She reported that first luxura hd pen she had, which she used for several years, since an unknown date, got stuck (pc number (b)(4) lot number unknown) and her current luxura hd pen was sent as replacement.While administering human insulin isophane suspension 70%/human insulin 30%, her eyes were not very good due to diabetes (improper use).On 29-may-2022, she dropped her second humapen onto the kitchen floors solid tile and her pen got stuck and the screw that pressed onto the cartridge broke and detached from the pen (pc number (b)(4), lot number 1610g01).She kept the pen-cartridge combination in the fridge (improper use).The events loss of consciousness and blood glucose decreased were considered serious due to medical significance.Information regarding corrective treatment and outcome of the events was not provided.Status of human insulin isophane suspension 70%/human insulin 30% therapy was not provided.The operator of the humapen luxura half-dose pens was the patient, and her training status was not provided.The general humapen luxura half-dose pen model duration of use and the suspect humapen luxura half-dose pen duration of use was unknown.The action taken with the humapen luxura half-dose pen was unknown and its return was expected.The reporting consumer related the event of lack of drug effect with human insulin isophane suspension 70%/human insulin 30% drug while did not provide the relatedness assessment between the rest of events and human insulin isophane suspension 70%/human insulin 30% drug and suspect humapen luxura hd device.Edit 09jun2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 13-jun-2022: upon review of information, updated narrative date for reported pc for humapen luxura hd lot no 1610g01, updated product complaint description for humapen luxura hd lot no unknown, updated improper use and storage for both humapen luxura hd devices to yes.Updated narrative accordingly.Update 16jun2022: additional information received on 15jun2022 from global product complaint database.Updated the lot number from unknown to 1610g01 for product complaint (b)(4) related to the humapen luxura half-dose pen.Recoded both suspect devices from humapen luxura half-dose pen (model number ms9673a) to humapen luxura half-dose pen (model number ms9673).Narrative and corresponding field was updated accordingly.Edit 17jun2022: recoded both suspect devices from humapen luxura half-dose pen (model number ms9673) to humapen luxura half-dose pen (model number ms9673a).No other information was updated.Update 23jun2022: additional information received on 22jun2022 from global product complaint database.Updated the lot number from 1610g01 to unknown for product complaint (b)(4) related to humapen luxura half-dose pen.Corresponding fields and narrative updated accordingly.Update 09aug2022: additional information received on 04aug2022 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields for the suspect humapen luxura hd device associated with (b)(4).Updated malfunction from unknown to yes/not cirm, and device return status to returned to manufacturer; and added date of manufacture and date returned to manufacturer for the suspect humapen luxura hd 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: 14755858
• MDR Text Key: 295056697
• Report Number: 1819470-2022-00044
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 1610G01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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 Sex: Female