MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 05/07/2023

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 spontaneous case, reported by a pharmacist who contacted the company to report an adverse event and product complaint, concerned a 16-years-old (at the time of initial report) male patient of unknown origin.Medical history included increase in electrical activity in brain and speaking disability.Concomitant medication was not provided.The patient received insulin lispro (rdna origin) injection (humalog, 100u/ml) from an unknown formulation, via reusable pen humapen ergo ii, 8 units in morning, 8 units at noon and 10 units in the evening, subcutaneously, for the treatment of type i diabetes mellitus, beginning on an unspecified date in 2018.On an unknown date while on insulin lispro therapy he experienced that the humapen was not releasing the insulin and was heavy on pressing (pc (b)(4)/ lot 1806d03).He changes the needle every day after three times of using and stores the pen in refrigerator (considered improper use and storage).On (b)(6)2023, while on insulin lispro therapy he experienced disturbance in blood glucose level (units, values and reference range was not provided) due to which he was admitted in intensive care units (icu).On (b)(6)2023, 15 days after being hospitalized he was discharged from the hospital.He was fully recovered from the event.The information regarding the corrective treatment details and further hospitalization details were not provided.Insulin lispro therapy was ongoing.The operator of the humapen ergo ii device was the patient and his training status was not provided.The device model duration of use was not provided but was started on an unspecified date in 2018 and the suspect device duration of use was not reported.The action taken with the suspect device was not provided and its return status was expected.The initial reporting pharmacist assessed the relatedness of the event with the insulin lispro therapy and humapen ergo ii device as unknown.Update 07-jun-2023: information was received from the initial consumer on (b)(6)2023.No new medically significant information was received and no other changes were made to the case.Edit 07jun2023 updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.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(s) dated 25jul2023 in the b.5.Field.No further follow-up is planned.Evaluation summary a pharmacist reported on behalf of a male patient reported that the patient's humapen ergo ii device was not releasing the insulin and was heavy on pressing.The patient experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch 1806d03, manufactured june 2018).Malfunction unknown.A batch record review and safety case review of the batch did not identify any atypical findings.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The patient reported changing needles after three uses and storing the device in the refrigerator.The core instructions for use state to use a new needle for each injection, to remove the needle after every use, to not store the pen with the needle attached, and to not to store the device in a refrigerator.There is evidence of improper use.The patient reused needles and stored the device in the refrigerator.These misuses may be relevant to the complaint that the device was not releasing insulin and the event of abnormal blood glucose.

Event Description

Lilly case id: (b)(6) this report is associated with product complaint: (b)(4) this spontaneous case, reported by a pharmacist who contacted the company to report an adverse event and product complaint, concerned a 16-years-old (at the time of initial report) male patient of unknown origin.Medical history included increase in electrical activity in brain and speaking disability.Concomitant medication was not provided.The patient received insulin lispro (rdna origin) injection (humalog, 100u/ml) cartridge, via reusable pen humapen ergo ii, (b)(4) units in morning, (b)(4) units at noon and 10 units in the evening, subcutaneously, for the treatment of type i diabetes mellitus, beginning on an unspecified date in 2018.On an unknown date while on insulin lispro therapy he experienced that the humapen was not releasing the insulin and was heavy on pressing (b)(4) lot 1806d03).He changes the needle every day after three times of using and stores the pen in refrigerator (considered improper use and storage).On (b)(6) 2023, while on insulin lispro therapy he experienced disturbance in blood glucose level (units, values and reference range was not provided) due to which he was admitted in intensive care units (icu).On (b)(6) 2023, 15 days after being hospitalized he was discharged from the hospital.He was fully recovered from the event.The information regarding the corrective treatment details and further hospitalization details were not provided.Insulin lispro therapy was ongoing.The operator of the humapen ergo ii device was the patient and his training status was not provided.The device model duration of use was not provided but was started on an unspecified date in 2018 and the suspect device duration of use was not reported.The action taken with the suspect device was not provided and it did not return to manufacturer.The initial reporting pharmacist assessed the relatedness of the event with the insulin lispro therapy and humapen ergo ii device as unknown.Update 07-jun-2023: information was received from the initial consumer on (b)6) 2023.No new medically significant information was received and no other changes were made to the case.Edit 07jun2023 updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 15-jun-2023: information was received from the initial reporter on (b)(6) 2023.No new medically significant information was received and no other changes were made to the case.Update 25jul2023: additional information received on 19jul2023 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, and device return status to not returned to manufacturer; and added date of manufacture for the suspect humapen ergo ii device associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 26jul2023: upon internal review recoded insulin lispro from unknown formulation to insulin lispro cartridge.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): TECH GROUP NORTH AMERICA INC. DBA WEST; 640 south rockford drive; tempe AZ
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN
• MDR Report Key: 17127653
• MDR Text Key: 317217220
• Report Number: 1819470-2023-00045
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1806D03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2018
• 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: 16 YR
• Patient Sex: Male