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 Problem Hyperglycemia (1905)

Event Date 05/10/2023

Event Type  Injury  

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 09-year-old (at the time of initial report) female patient of unknown origin.Medical history and concomitant medication were not provided.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) from unknown formulation via reusable pen humapen luxura hd, 5 units in morning, 8 units at noon and 2 units at night, subcutaneously, for the treatment of type one diabetes mellitus, beginning on an unspecified date in 2017.On (b)(6) 2023, while on insulin lispro therapy she experienced that the pen did not release insulin which resulted in elevation in blood glucose level, reached up to 500mg/dl (reference range was not provided).The pen screw was stuck and it was not working properly so no insulin was released ((b)(4)/lot: 1208g08).She stored the pen in the refrigerator when the weather was hot and changes the pen needle every three days (improper use and storage).On (b)(6) 2023 she was hospitalized due to the blood glucose increased.She received intravenous saline solution in the hospital to decrease the blood glucose level.She had fully recovered from the events.The information regarding further hospitalization details were not provided.Insulin lispro therapy was ongoing.The operator of the humapen luxura hd was the patient and her training status was unknown.The device model duration of use and the suspect device duration of use was two years.The action taken with the suspect device was not provided and its return status not expected.The initial reporting consumer did not relate the events with the insulin lispro therapy while related the events with the humapen.Edit 26-may-2023: upon review of the information received on 13-may-2023, the luxura hd device was recoded to (b)(4); improper use or storage was updated from no to yes in device tab and in narrative; eu/ca fields were completed and accepted (b)(4) in catool.No other changes were made to the case.Edit 01jun2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.

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.

Manufacturer Narrative

No further follow-up is planned.B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement dated 28jun2023 in the b.5.Field.Evaluation summary the father of a female patient reported that the pen screw of his daughter's humapen luxura hd was stuck, and it was not working properly so no insulin was released.He stated that sometimes the pen releases insulin in the air normally.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1208g08, manufactured august 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to injection screw/ratchet not moving issues.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 reporter stated the pen was stored in the refrigerator when the weather was hot and the pen needle is changed every three days.The core instructions for use states to not to store the device in a refrigerator and to use a new needle for each injection.In addition, based on the reported batch number, the device was manufactured in august 2012; therefore, it is likely the device was used beyond its approved use life.The core instructions for use state the humapen luxura hd is designed to be used for up to 3 years after first use.There is evidence of improper use and storage.The user reuses needles and stores the device in the refrigerator.These misuses may be relevant to the complaint and the event of increased blood glucose.The user likely used the device beyond its approved use life.It is unknown if this is relevant to the event of increased blood glucose.

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 09-year-old (at the time of initial report) female patient of unknown origin.Medical history and concomitant medication were not provided.The patient received insulin lispro (rdna origin) injection (humalog 100u/ml) from unknown formulation via reusable pen humapen luxura hd, 5 units in morning, 8 units at noon and 2 units at night, subcutaneously, for the treatment of type one diabetes mellitus, beginning on an unspecified date in 2017.On (b)(6) 2023, while on insulin lispro therapy she experienced that the pen did not release insulin which resulted in elevation in blood glucose level, reached up to 500mg/dl (reference range was not provided).The pen screw was stuck and it was not working properly so no insulin was released (pc 6490372/lot 1208g08).She stored the pen in the refrigerator when the weather was hot and changes the pen needle every three days (improper use and storage).On (b)(6)2023 she was hospitalized due to the blood glucose increased.She received intravenous saline solution in the hospital to decrease the blood glucose level.She had fully recovered from the events.The information regarding further hospitalization details were not provided.Insulin lispro therapy was ongoing.The operator of the humapen luxura hd was the patient and her training status was unknown.The device model duration of use and the suspect device duration of use was two years.The action taken with the suspect device was not provided.Humapen luxura hd device did not return to manufacturer.The initial reporting consumer did not relate the events with the insulin lispro therapy while related the events with the humapen.Edit 26-may-2023: upon review of the information received on 13-may-2023, the luxura hd device was recoded to ms9673a; improper use or storage was updated from no to yes in device tab and in narrative; eu/ca fields were completed and accepted pc#(b)(4) in catool.No other changes were made to the case.Edit 01jun2023: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 28jun2023: additional information received on 23jun2023 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 device humapen luxura hd associated with pc (b)(4).Added date of manufacturer.Change humalog formulation from unknown to a cartridge formulation.Corresponding fields and narrative updated accordingly.Edit 17jul2023: updated udi field for expedited device reporting.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, WI 46285 ; 3174334585
• MDR Report Key: 17049805
• MDR Text Key: 316400631
• Report Number: 1819470-2023-00041
• 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,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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: 1208G08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2012
• 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): Hospitalization
• Patient Age: 9 YR
• Patient Sex: Female