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

Model Number MS9557

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hyperglycemia (1905)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem.Please refer to statement dated (b)(6) 2021 in the describe event or problem field.No further follow up is planned.Evaluation summary: the reporter stated the patient was using the same application pen for almost 6-7 years.There was no product complaint for the device, and the device was not returned for investigation.There was evidence of improper use of the device.The same application pen was used for almost 6-7 years.The user manual states do not use your pen for more than 3 years after the first use or past the use-by date on the carton.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of unknown origin.Medical history included diabetes mellitus, blood pressure in bad condition, kidney disorder and was on dialysis since 1986.Concomitant medication included insulin glargine for the treatment of diabetes mellitus and unspecified medication for heart disorder, kidney and high blood pressure.The patient received human insulin (rdna origin) injection (humulin r) from cartridge via a humapen ergo ii re-usable device 22 units daily (8 in morning, 8 in noon and 6 in evening) via unknown route, for the treatment of diabetes mellitus, beginning somewhere in 2014.She was using the same humapen ergo ii device since six to seven years which was considered to be improper use.On an unknown date in 2019, she experienced loss of consciousnesses, heart disorder, all levels were high of blood sugar and blood pressure.On (b)(6) "20219", she got hospitalized for 15 days in emergency due to these events.On (b)(6) 2021, her husband died and her event of loss of consciousness got worse and she also experienced depression since then.She was also on dialysis.Some where in (b)(6) 2021, she lost her humapen ergo ii device.Information regarding the corrective treatment, outcome of the events and the status of the human insulin therapy was not provided.The operator of the humapen ergo ii re-usable device was patient herself and her training status was not provided.The general humapen ergo ii re-usable device model duration of use was not provided but it was started somewhere in 2014.The duration of use of suspect humapen ergo ii re-usable device was unknown.The action taken with suspect humapen ergo ii re-usable device was not provided and its return was not expected.The reporting consumer did not provide the relatedness assessment between the events and the human insulin therapy or suspect humapen ergo ii re-usable device.Update 12nov2021: additional information received on 12nov2021.Entered the device specific safety summary (dsss); updated the medwatch and european and (b)(6) (eu/(b)(6)) device fields for the suspect device.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): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 12805590
• MDR Text Key: 282735302
• Report Number: 1819470-2021-00150
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 11/12/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/12/2021
• 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: 66 YR
• Patient Sex: Female