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

Model Number MS9557

Device Problem Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

No further follow-up is planned.This report is associated with 1819470-2021-00141 since there is more than one device implicated.Evaluation summary a female patient reported that at the end of (b)(6) 2021 or early (b)(6) 2021, the black injection screw of her humapen ergo ii device did not move and had no elasticity, the injection button also could not be pressed down and insulin could not be ejected out.The patient experienced diabetic complications on an unspecified date between (b)(6) 2021.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 with high probability.The patient reported that she had used the device for six years.The core instructions for use state the humapen ergo ii has been designed to be used for up to 3 years after first use.There is evidence of improper use.The patient used the device beyond the recommended use period.It is unknown if the misuse is relevant to the event of diabetic complications.

Event Description

(b)(4).This spontaneous case, reported by a consumer, concerned a (b)(6) asian female patient with ethnicity reported as (b)(6).Medical history of patient included the three highs: hypertension, hyperglycemia and hyperlipidemia.Concomitant medications were not provided.The patient received insulin lispro regular 25% + insulin lispro nph 75% (rdna origin) (humalog 25) from cartridges via humapen ergo ii, 20units in the morning and 20 units in the evening, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 2015.On an unspecified date, reported as end of (b)(6) 2021 or early (b)(6) 2021, approximately six years after commencing insulin lispro regular 25% + insulin lispro nph 75%, the black injection screw of the humapen ergo ii (unknown lot number, (b)(4)) did not move and had no elasticity, the injection button also could not be pressed down and insulin lispro could not be ejected out.Further information was not provided.On an unknown date in (b)(6) 2021, the patient changed to another humapen ergo ii.On an unspecified date between (b)(6) 2021, unclear if after switching to second humapen ergo ii, the patient was hospitalized for recuperation because of diabetes mellitus and hypertension.Information regarding laboratory exams and corrective treatment was not provided.On the evening of (b)(6) 2021, the black injection screw of the second humapen ergo ii did not move and had no elasticity, the injection button also could not be pressed down (unknown lot number, (b)(4)) and insulin could not be ejected out.Reportedly, three cartridges of insulin lispro regular 25% + insulin lispro nph 75% had been used already and due the malfunction of the pen, the patient did not receive insulin injection.It was also reported that when patient had hypoglycemia, she would be better after eating something, but further information was not provided.Information regarding laboratory exams and other corrective treatment was not provided.It was unknown if the patient recovered from the events.As of (b)(6) 2021, patient still had not received insulin lispro regular 25% + insulin lispro nph 25% injection.It was unknown who operated the devices and if the operator was trained.The duration for use of humapen ergo ii device associated with (b)(4) was approximately six years and the humapen ergo ii suspect device associated with (b)(4) was approximately less than a month.The status of devices were not provided.The suspect humapen ergo ii associated with (b)(4) and the suspect humapen ergo ii device associated with (b)(4) were not returned to the manufacturer.The reporting consumer did not know if the events were related to insulin lispro regular 25% + insulin lispro nph.The consumer related the dose omission to the second humapen ergo ii.Update 05oct2021: additional information received on 30sep2021 from complaint personnel and from second reporting consumer were processed together within initial case entry.Update 26oct2021: additional information received on 22oct2021 from global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields with device information and the european and (b)(6) (eu/(b)(6)) device information for the suspect humapen ergo ii device associated with (b)(4) and the suspect humapen ergo ii device associated with (b)(4) were not returned to the manufacturer.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
• MDR Report Key: 12715203
• MDR Text Key: 282572907
• Report Number: 1819470-2021-00140
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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?: No
• Date Manufacturer Received: 09/30/2021
• 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: 70 YR