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

Model Number MS9557

Device Problems Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Leak/Splash (1354); Use of Device Problem (1670); Inaccurate Delivery (2339); Patient Device Interaction Problem (4001)

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

Event Type  Injury  

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 complaint (pc), concerns a male patient of an unknown age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog 100units/ml) from a cartridge via a reusable device (humapen ergo ii), 8 units in morning, 10 units in afternoon and 15 units at night, three times a day (tid), subcutaneously, for the treatment of an unknown indication, beginning approximately in year 2004.He bought a new reusable device of humapen ergo ii in (b)(6) 2022 (exact date not provided).He always stored the device with a refill in the refrigerator and needle attached to it (improper use).Since an unspecified date, in the last few days, while on insulin lispro therapy, the device was dispensing more insulin than the selected dose and he experienced episodes of hypoglycemia due to that.The device dispensed drops of insulin even when it was not used ((b)(4), lot unknown).Every time he used the device, he felt sick from losing consciousness and his glycemic rate had already reached values such as 25, 27 and 30 (units and reference range not provided).He was taken to the hospital because of this.Further hospitalization details, corrective treatment, outcome of the events and status of insulin lispro therapy was not provided.The operator of humapen ergo ii was unknown and his/her training status was not provided.The general humapen ergo ii device duration of use was not reported.The suspect humapen ergo ii device duration of use was not reported however it was started in (b)(4).The action taken with the suspect humapen ergo ii device was not provided and its return was not expected.The reporting consumer did not provide any relatedness between the events and insulin lispro drug.The reporting consumer did not provide any relatedness for loss of consciousness however assessed hypoglycemia as related to suspect humapen ergo ii device.Edit 15-aug-2022: upon review of the initial information, updated device causality for hypoglycemia, added partial start date for the suspect device and removed the information of vision abnormal, from narrative.No further changes were made to the case.Edit 16aug2022: 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.

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 complaint (pc), concerns a male patient of an unknown age and origin.Medical history and concomitant medications were not provided.The patient received insulin lispro (rdna origin) (humalog 100units/ml) from a cartridge via a reusable device (humapen ergo ii), 8 units in morning, 10 units in afternoon and 15 units at night, three times a day (tid), subcutaneously, for the treatment of an unknown indication, beginning approximately in year 2004.He bought a new reusable device of humapen ergo ii in (b)(6) 2022 (exact date not provided).He always stored the device with a refill in the refrigerator and needle attached to it (improper use).Since an unspecified date, in the last few days, while on insulin lispro therapy, the device was dispensing more insulin than the selected dose and he experienced episodes of hypoglycemia due to that.The device dispensed drops of insulin even when it was not used ((b)(4), lot 2001d04).Every time he used the device, he felt sick from losing consciousness and his glycemic rate had already reached values such as 25, 27 and 30 (units and reference range not provided).He was taken to the hospital because of this.Further hospitalization details, corrective treatment, outcome of the events and status of insulin lispro therapy was not provided.The operator of humapen ergo ii was unknown and his/her training status was not provided.The general humapen ergo ii device duration of use was not reported.The suspect humapen ergo ii device duration of use was not reported however it was started in (b)(6) 2022.The action taken with the suspect humapen ergo ii device was not provided and it returned to manufacturer.The reporting consumer did not provide any relatedness between the events and insulin lispro drug.The reporting consumer did not provide any relatedness for loss of consciousness however assessed hypoglycemia as related to suspect humapen ergo ii device.Edit 15-aug-2022: upon review of the initial information, updated device causality for hypoglycemia, added partial start date for the suspect device and removed the information of vision abnormal, from narrative.No further changes were made to the case.Edit 16aug2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 18-aug-2022: both the information received on 11-aug-2022 and on 16-aug-2022 were processed together.No new clinically or medically significant information was added in the case.Narrative updated accordingly.Update 22-aug-2022: all additional information received from the initial reporting consumer on 17-aug-2022, was processed at the same time.Added lot number of the suspect device.Updated narrative accordingly.Update 02nov2022: additional information received on 27oct2022 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields, malfunction from unknown to no, and device return status to returned to manufacturer; and added date of manufacture and date returned to manufacturer for the suspect humapen ergo ii device associated with pc (b)(4).Corresponding fields and narrative updated accordingly.

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 02nov2022 in the b.5.Field.No further follow-up is planned.Evaluation summary a male patient reported that his humapen ergo ii device was dispensing more insulin than the selected dose and dispensed drops of insulin even when it was not used.The patient experienced hypoglycemia and loss of consciousness.The investigation of the returned device (batch 2001d04, manufactured january 2020) found the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.The patient reported that he always stored the device with a refill in the refrigerator and with the needle attached to it, and he reuses the needles.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 and storage.The patient stored the pen with the needle attached in the refrigerator, and reused needles.These misuses may be relevant to the complaint that the device dispensed drops of insulin even when it was not used and the perception that it was dispensing more insulin than the selected dose.It is unknown if these misuses are relevant to the event of hypoglycemia and loss of consciousness.

• 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): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 15233842
• MDR Text Key: 297992008
• Report Number: 1819470-2022-00059
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K151686
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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: 2001D04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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: Male