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

Model Number MS9557

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

Patient Problems Hypoglycemia (1912); Coma (2417)

Event Date 01/31/2018

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.This report is associated with 1819470-2023-00068 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 solicited case, reported by a consumer, via a patient support program (psp), concerned a 73-years old female patient of unknown origin.Medical history included hypertension and kidney function disturbance.The concomitant medications were unknown.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge, administered subcutaneously, for the treatment of diabetes mellitus, via a reusable pen humapen ergo ii, beginning since an unknown date, from several years ago.She also received unspecified insulin from several years ago for diabetes mellitus.Dosage regimen, therapy start date and frequency was not provided.Since an unknown date, when she administered human insulin isophane suspension 70%/human insulin 30% with unspecified insulin, she used to suffer from diabetic coma frequently, which led her to lose her consciousness with excessive sweating due to hypoglycemia as the blood glucose level reached to 60mg/dl.(lot.No.2010d02, pc no.(b)(4)) and (lot no.0810d03, pc no.(b)(4)).Her physician related hypoglycemia to administering two types of insulin so, the physician recommended to stop the other type of insulin and keep only human insulin isophane suspension 70%/human insulin 30% therapy.She was not hospitalized for diabetic coma and took sweets as corrective treatment to adjust her blood glucose level.Since an unknown date in (b)(6) 2023, she suffered from yellowish skin, and it was diagnosed as disability of draining the bilirubin so, the physician recommended to perform surgery to insert plastic stent in her gallbladder.On an unknown date in (b)(6) 2023, a surgery was performed to replace the inserted plastic stent in gallbladder with metal stent.She was hospitalized for three weeks and discontinued human insulin isophane suspension 70%/human insulin 30% during hospitalization as per physician recommendation and restarted human insulin isophane suspension 70%/human insulin 30% again after leaving hospital.It was reported she used to suffer from elevation in creatinine level which reached to 1.7 (units, date and reference range not provided).It was reported she changed the needle on every cartridge consumption and stored the device in refrigerator while still attached (improper use).The event of diabetic hypoglycemic coma was considered serious by the company due to medical significance.Further information regarding corrective treatment and hospitalization details were unknown.Outcome of blood creatinine increased was not resolved and outcome of remaining events were resolved.Status of unspecified insulin was discontinued on unknown date, status of human insulin isophane suspension 70%/human insulin 30% therapy was discontinued and again restarted on unknown dates and was ongoing as of (b)(6) 2023.The patient was the operator of devices, and her training status was not provided.The general and suspect humapen ergo ii models duration of use were unknown.The action taken with suspect humapens was unknown and their return status was unknown.The reporting consumer did not consider the events related with human insulin isophane suspension 70%/human insulin 30% drug or humapen ergo ii devices.The reporting consumer did not provide relatedness of events with unspecified insulin.Update (b)(6) 2023: information received on (b)(6) 2023 and (b)(6) 2023 were processed together.Edit (b)(6) 2023: updated medwatch fields for expedited device reporting.No new information added.

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(s) dated 09oct2023 in the b.5.Field.This report is associated with 1819470-2023-00068 since there is more than one device implicated.Evaluation summary a female patient reported that her humapen ergo ii device's "button wasn't pressed down, the dose knob rotated on loss, and no insulin was released." the patient experienced hypoglycemic coma.The device was not returned to the manufacturer for investigation (batch 2010d02, manufactured october 2020).Malfunction unknown.A safety case review of the batch and a batch record review 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 with high probability.The patient reported changing needles only with a new cartridge.The core instructions for use state to use a new needle for each injection.The patient stored the device with the needle attached in the refrigerator.The core instructions for use state to use a new needle for each injection, to remove the needle after every use, and to not store the device in a refrigerator.There is evidence of improper use.The patient reused needles, stored the device with the needle attached and in the refrigerator.These misuses may be relevant to the complaint issue.It is not likely these misuses are relevant to the event hypoglycemic coma.

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 73-years old female patient of unknown origin.Medical history included hypertension and kidney function disturbance.The concomitant medications were unknown.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge, administered subcutaneously, for the treatment of diabetes mellitus, via a reusable pen humapen ergo ii, beginning since an unknown date, from several years ago.She also received unspecified insulin from several years ago for diabetes mellitus.Dosage regimen, therapy start date and frequency was not provided.Since an unknown date, when she administered human insulin isophane suspension 70%/human insulin 30% with unspecified insulin, she used to suffer from diabetic coma frequently, which led her to lose her consciousness with excessive sweating due to hypoglycemia as the blood glucose level reached to 60mg/dl.(lot.No.2010d02, pc no.6721963) and (lot no.0810d03, pc no.6721966).Her physician related hypoglycemia to administering two types of insulin so, the physician recommended to stop the other type of insulin and keep only human insulin isophane suspension 70%/human insulin 30% therapy.She was not hospitalized for diabetic coma and took sweets as corrective treatment to adjust her blood glucose level.Since an unknown date in jan-2023, she suffered from yellowish skin, and it was diagnosed as disability of draining the bilirubin so, the physician recommended to perform surgery to insert plastic stent in her gallbladder.On an unknown date in may-2023, a surgery was performed to replace the inserted plastic stent in gallbladder with metal stent.She was hospitalized for three weeks and discontinued human insulin isophane suspension 70%/human insulin 30% during hospitalization as per physician recommendation and restarted human insulin isophane suspension 70%/human insulin 30% again after leaving hospital.It was reported she used to suffer from elevation in creatinine level which reached to 1.7 (units, date and reference range not provided).It was reported she changed the needle on every cartridge consumption and stored the device in refrigerator while still attached (improper use).The event of diabetic hypoglycemic coma was considered serious by the company due to medical significance.Further information regarding corrective treatment and hospitalization details were unknown.Outcome of blood creatinine increased was not resolved and outcome of remaining events were resolved.Status of unspecified insulin was discontinued on unknown date, status of human insulin isophane suspension 70%/human insulin 30% therapy was discontinued and again restarted on unknown dates and was ongoing as of (b)(6) 2023.The patient was the operator of devices, and her training status was not provided.The general and suspect humapen ergo ii models duration of use were unknown.The action taken with suspect humapens was unknown.Humapen ergo ii devices did not return to manufacturer.The reporting consumer did not consider the events related with human insulin isophane suspension 70%/human insulin 30% drug or humapen ergo ii devices.The reporting consumer did not provide relatedness of events with unspecified insulin.Update 21-sep-2023: information received on 16-sep-2023 and 18-sep-2023 were processed together.Edit 22sep2023: updated medwatch fields for expedited device reporting.No new information added.Update 09oct2023: additional information received on 04oct2023 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for the humapen ergo ii devices associated with (b)(4) and (b)(4).Corresponding fields and narrative updated accordingly.

• 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 85281
• Manufacturer Contact: catherine cassidy ; lilly corporate center; indianapolis 46285 ; 3174332191
• MDR Report Key: 17800071
• MDR Text Key: 324056019
• Report Number: 1819470-2023-00069
• 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,Study,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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: MS9557
• Device Lot Number: 2010D02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Female