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

Model Number MS9557

Device Problem Defective Component (2292)

Patient Problems Memory Loss/Impairment (1958); Complaint, Ill-Defined (2331)

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 report will be submitted when the final evaluation has been completed.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old (at the time of the initial report) asian female patient.Medical history included cerebral thrombosis and hereditary diabetes.Concomitant medications included voglibose and metformin for unknown indication.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) through cartridge via reusable pen (humapen ergo ii), 12 units each morning and 10 units each night subcutaneously for the treatment of diabetes mellitus starting in 2016.On an unspecified date in 2018 due to the regulation of blood sugar, she was hospitalized for more than ten days.As reported her memory was poor since an unknown date.Since (b)(6) 2019, she had been unable to inject insulin due to a malfunction of the injection pen (product complaint: 4790171; lot: 1610d03).Information regarding further corrective treatment, outcome of the events and insulin lispro status was not provided.The user of the humapen ergo ii was unknown and his/her training status was not provided.The humapen ergo ii model duration of use started in 2018 and the suspect humapen ergo ii duration of use was unknown.The action taken with the suspect humapen ergo ii was unknown and its return was not expected.The reporting consumer did know if the events were related to insulin lispro or humapen ergo ii.Edit 08jul2019: updated medwatch and european and (b)(4) fields for expedited device reporting.No new information added.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 79 year old (at the time of the initial report) asian female patient.Medical history included cerebral thrombosis and hereditary diabetes.Concomitant medications included voglibose and metformin for unknown indication.The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injections (humalog mix25) through cartridge via reusable pen (humapen ergo ii), 12 units each morning and 10 units each night subcutaneously for the treatment of diabetes mellitus starting in 2016.On an unspecified date in 2018 due to the regulation of blood sugar, she was hospitalized for more than ten days.As reported her memory was poor since an unknown date.Since(b)(6) 2019, she had been unable to inject insulin due to a problem with the injection pen (product complaint (b)(4); lot 1610d03).Information regarding further corrective treatment, outcome of the events and insulin lispro status was not provided.The user of the humapen ergo ii was unknown and his/her training status was not provided.The humapen ergo ii model duration of use started in 2018 and the suspect humapen ergo ii duration of use was unknown.The action taken with the suspect humapen ergo ii was unknown and it was not returned to the manufacturer.The reporting consumer did know if the events were related to insulin lispro or humapen ergo ii.Edit 08jul2019: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 31jul2019: additional information received on 25jul2019 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 yes, not cirm to no.Added the date of manufacture for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.Edit 19aug2019: updated medwatch 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 statement dated 31jul2019 in the b.5.Field.No further follow up is planned.This is a downgrade report, which no longer meets the criteria for expedited reporting.Evaluation summary: a female patient reported that the injection screw of her humapen ergo ii device could not move and insulin was not injected while the injection button could be pushed down.The patient experienced abnormal blood glucose.The device was not returned for investigation (batch 1610d03, manufactured october 2016).The pen was checked by a diabetes educator; the issue was solved, and the pen was working normally.A complaint history review did not identify any atypical findings with regard to dose accuracy.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.There is no evidence of improper use.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 8781999
• MDR Text Key: 150748861
• Report Number: 1819470-2019-00125
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2018
• Device Model Number: MS9557
• Device Lot Number: 1610D03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 55