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

Model Number MS9673A

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Manufacturer Narrative

Reportable malfunction/incident identified.Investigation in progress.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 (psp), concerned a 07-year-old pediatric female patient of an unknown origin.Medical history not provided.Concomitant medication included insulin glargine for diabetes mellitus.The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from a cartridge using reusable pen humapen luxura hd, with changeable dosage and frequency via unknown route for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date, after starting insulin lispro therapy, she experienced that her blood glucose level remained very high during a day, the blood glucose level did not decrease and increased to 400-500 (no units and reference range provided) when the application pen was checked, it was understood that the black stick was not push the medicine (batch unknown, (b)(4)), she was admitted to the hospital at night as a precaution.At the hospital, physician prescribed insulin lispro kwikpen and a new humapen ergo ii was sent.The blood glucose level was returned to normal level however she remained ill for few days it was like the flu.Information about corrective treatment was unknown, outcome of the remaining event was unknown.Status of insulin lispro therapy was ongoing.The patient was operator of the humapen luxura hd device, and her training status was unknown.The general model humapen luxura hd device duration and the suspect humapen luxura hd device duration were not provided.The suspect humapen luxura hd device status and its return status was expected.The reporting consumer did not provide an opinion of relatedness of the events to the insulin lispro therapy and the humapen luxura hd device.Edit 24-feb-2023: non med sig edit required to update device distributed within the following countries and device available for evolution.Edit 03mar2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.Added udi number for suspect device humapen luxura half-dose.No new information added.

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 dated 27mar2023 in the b.5.Field.No further follow-up is planned.Evaluation summary: the father of a female patient reported that it "the black stick" (injection screw) of the patient's luxura hd "was not pushing the drug." the patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch number 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 luxura hd core instructions for use states to always carry a spare insulin pen in case your pen is lost or damaged.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 (psp), concerned a 07-year-old pediatric female patient of an unknown origin.Medical history not provided.Concomitant medication included insulin glargine for diabetes mellitus.The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from a cartridge using reusable pen humapen luxura hd, with changeable dosage and frequency via unknown route for the treatment of diabetes mellitus beginning on an unknown date.On an unknown date, after starting insulin lispro therapy, she experienced that her blood glucose level remained very high during a day, the blood glucose level did not decrease and increased to 400-500 (no units and reference range provided) when the application pen was checked, it was understood that the black stick was not push the medicine (batch unknown, pc 6354626), she was admitted to the hospital at night as a precaution.At the hospital physician prescribed insulin lispro (rdna origin) (humalog), via a prefilled pen, kwikpen and a new humapen ergo ii was sent.Dose and frequency for insulin lispro (kwikpen) was not provided but her dose of it, was adjusted according to what she ate.The blood glucose level was returned to normal level however she remained ill for few days it was like the flu.Reporting consumer did not know what treatment was given in the hospital, since the patient's mother remained in the hospital, but according to reporter it was possible that insulin glargine (lantus) was applied.Her blood tests (name and values unspecified) were done but reporting consumer did not know the results.It was reported that after the first reporting date (20-feb-2023), on an unknown date, she experienced hypoglycemia and was hospitalized for one week and stayed in the intensive care unit (icu) for three days.She had taken 11 units of insulin glargine (lantus) as usual, but her blood glucose had dropped a lot (value not provided) and cause for hypoglycemia was unknown.Information regarding further corrective treatment and outcome of the remaining events was unknown.Status of insulin lispro (kwikpen) therapy was ongoing.Follow up was not possible as reporter did not want to be called for follow-up.The patient was the operator of the humapen luxura hd device and humalog kwikpen, and her training status was unknown.The general model duration of use and the suspect humapen luxura hd device and humalog kwikpen device durations were not provided.The suspect humapen luxura hd and humalog kwikpen devices were not returned to the manufacturer for investigation.The reporting consumer assessed relatedness for event of blood glucose increased as not related with insulin lispro (cartridge) drug and as related to product complaint associated with humapen luxura half-dose.The reporting consumer did not know relatedness for the event of hypoglycemia with insulin lispro (cartridge and kwikpen) drugs and did not provide relatedness for remaining event with insulin lispro (cartridge and kwikpen) drugs.The reporting consumer did not provide relatedness for the event of hypoglycemia with humapen luxura half-dose and insulin lispro kwikpen.Edit 24-feb-2023: non med sig edit required to update device distributed within the following countries and device available for evolution.Edit 03mar2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.Added udi number for suspect device humapen luxura half-dose.No new information added.Update 27mar2023: additional information received on 22mar2023 from the global product complaint database.Entered device specific safety summary (dsss) for humapen luxura hd device associated with pc (b)(4), lot unknown updated the medwatch fields/ european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Corresponding fields and narrative updated accordingly.Update 04-apr-2023: additional information received on 31-mar-2023 from initial reporting consumer.Added a suspect drug insulin lispro (kwikpen) and a suspect device of insulin lispro kwikpen and a serious event of hypoglycemia.Updated as reported causality in narrative for event of blood glucose increased as not related with insulin lispro (cartridge) drug and as related with humapen luxura half-dose, and narrative with new information.Edit 06apr2023: updated medwatch fields for expedited device reporting.Added humalog kwikpen details to the device use paragraph.No new information added.

• 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: 16496444
• MDR Text Key: 310808441
• Report Number: 1819470-2023-00017
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• 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?: Yes
• Date Manufacturer Received: 03/22/2023
• 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): Hospitalization
• Patient Age: 7 YR
• Patient Sex: Female