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

Model Number MS9557

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Inaccurate Delivery (2339); Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 12/31/2021

Event Type  Injury  

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 (b)(6) female patient of an unknown origin.Medical history was not provided.The concomitant medication included vildagliptin and insulin glargine for the treatment of hyperglycemia.The patient received insulin lispro (rdna origin) through a cartridge, via a reusable pen (humapen ergo ii), 20 units after each meal, subcutaneously, for the treatment of hyperglycemia, beginning on an unknown date.On an unknown date approximately in (b)(6) 2021, she suffered from hypoglycemia at night and needed to go to the hospital and get fully recovered there.She complaint from the pen that the dose knob was not accurate, and she took wrong doses due to this problem, and the liquid was leaking out from the pen ((b)(4), batch - unknown).She had recovered from the events.Information regarding corrective treatment was not reported.The status of therapy with insulin lispro was continued.The user of the humapen ergo-ii was unknown, and his/her training status was not provided.The humapen ergo-ii general and suspect device duration of use were not provided.The action taken with the suspect humapen ergo-ii was unknown and its return was expected.The reporting consumer did not relate the event of hypoglycemia and did not provide opinion of relatedness between remaining event with insulin lispro therapy and related the events with humapen ergo-ii.Updated medwatch and (b)(6) 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.

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 18feb2022 in the b.5.Field.No further follow-up is planned.Evaluation summary a female patient reported that the dose knob of her humapen ergo ii device was not accurate, and she took the wrong dose due to this problem.She also reported liquid was leaking out from the pen.The patient experienced hypoglycemia.The device was not returned to the manufacturer for investigation (batch number unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.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 or storage.

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 72-year-old female patient of an unknown origin.Medical history was not provided.The concomitant medication included vildagliptin and insulin glargine for the treatment of hyperglycemia.The patient received insulin lispro (rdna origin) through a cartridge, via a reusable pen (humapen ergo ii), 20 units after each meal, subcutaneously, for the treatment of hyperglycemia, beginning on an unknown date.On an unknown date approximately in (b)(6)2021, she suffered from hypoglycemia at night and needed to go to the hospital and get fully recovered there.She complaint from the pen that the dose knob was not accurate, and she took wrong doses due to this problem, and the liquid was leaking out from the pen (pc number - (b)(4), batch - unknown).She had recovered from the events.Information regarding corrective treatment was not reported.The status of therapy with insulin lispro was continued.The user of the humapen ergo ii was unknown, and his/her training status was not provided.The humapen ergo-ii general and suspect device duration of use were not provided.The action taken with the suspect humapen ergo ii was unknown.It did not return to manufacturer.The reporting consumer did not relate the event of hypoglycemia and did not provide opinion of relatedness between remaining event with insulin lispro therapy and related the events with humapen ergo ii.Edit 01feb2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 18feb2022: additional information received on 16feb2022 from the global product complaint database.Entered the device specific safety summary (dsss); updated the medwatch and european and canadian (eu/ca) device fields; and added device not returned to manufacturer for the suspect device associated with (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): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285
• MDR Report Key: 13506081
• MDR Text Key: 288604463
• Report Number: 1819470-2022-00011
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/16/2022
• 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: 72 YR
• Patient Sex: Female