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 Type  Injury  

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement(s) dated (b)(6) 2019 in the field.No further follow-up is planned.Evaluation summary: the reporter stated the patient used the humapen ergo ii device from 2009 and was ongoing.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.It was reported that the device was used for about 10 years.The user manual states a humapen ergo ii device should not be used for more than 3 years after the first use.

Event Description

Lilly case id: (b)(4).This solicited case, reported by a consumer via patient support program (psp), concerned a male patient of unknown age and origin.Medical history included diabetes mellitus since 1999 (twenty years) and hospitalization in 2009.Concomitant medications were not provided.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin 70/30, 100u/ml) from a cartridge, via a reusable humapen ergo ii (blue), twice a day with unknown dose, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2009.On an unknown date in jul-2019, while on human insulin mix 70/30, he was hospitalized in for recuperation due to high blood sugar (fasting blood sugar value: 21, 22), and on an unknown date in (b)(6) 2019 he had been discharged.He was still using the reusable humapen ergo ii (blue) device (improper use).Information regarding corrective treatment and outcome of the event was not provided.Status of human insulin lispro mix 70/30 was ongoing.The patient was the operator of the reusable humapen ergo ii device and his training status was not provided.The general reusable humapen ergo ii device model duration of use was not provided and suspect reusable device duration of use was around 10 years as it was started since 2009.The suspect reusable humapen ergo ii device was ongoing and not returned to the manufacturer.The initial reporting consumer did not provide relatedness assessment between the events and human insulin mix 70/30 drug and humapen ergo ii device.Update 17-oct-2019: information received on 14-oct-2019 from complaint database.Pc 4913094 was received and processed.No changes were made to the case.Update 24-oct-2019: information received on 14-oct-2019 from complaint database was already present in the case.No changes were made to the case.Update 05nov2019: additional information received on 05nov2019 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information, and device return status to not returned to manufacturer for humapen ergo ii 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): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 9310873
• MDR Text Key: 185261343
• Report Number: 1819470-2019-00194
• 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
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• 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?: Yes
• Date Manufacturer Received: 10/14/2019
• 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