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

Model Number MS9557

Device Problem Use of Device Problem (1670)

Patient Problem Hyperglycemia (1905)

Event Date 08/31/2019

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 follow-up report will be submitted when the final evaluation is completed.

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 unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% treatment (rdna origin) injections (humalog mix25), from cartridge via a reusable device humapen ergo ii (bluish black), subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen was not provided.In (b)(6) 2019, while on insulin lispro protamine suspension 75%/insulin lispro 25% treatment, due to high blood glucose she was hospitalized.Reportedly, the humapen ergo ii was not easy to use and she wanted to buy an identical injection pen with the same model (lot number: unknown, product complaint number: (b)(4)).Further information regarding corrective treatment and outcome of the event was not provided.Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of humapen ergo ii and his/her training status was not provided.The general humapen ergo ii model duration was not provided but the suspect humapen ergo ii was started in (b)(6) 2019.The status of humapen ergo ii was unknown and its return was unknown.The initial reporting consumer did not provide an opinion of relatedness between the event and insulin lispro protamine suspension 75%/insulin lispro 25% treatment or humapen ergo ii.Update 16-oct-2020: both documents received on 14-oct-2020 were processed at same time.Edit 22-oct-2020: upon review of the initial information, the information regarding humapen ergo ii age was updated in narrative.

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 17nov2020 in the b.5.Field.No further follow-up is planned.Evaluation summary a female patient reported that her humapen ergo ii "was not easy to use." she experienced increased blood glucose.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 68-year-old female patient of unknown origin.Medical history and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% treatment (rdna origin) injections (humalog mix25), from cartridge via a reusable device humapen ergo ii (bluish black), subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date.Dosage regimen was not provided.In (b)(6) 2019, while on insulin lispro protamine suspension 75%/insulin lispro 25% treatment, due to high blood glucose she was hospitalized.Reportedly, the humapen ergo ii was not easy to use and she wanted to buy an identical injection pen with the same model (lot number: unknown, product complaint number:(b)(4).Further information regarding corrective treatment and outcome of the event was not provided.Status of insulin lispro protamine suspension 75%/insulin lispro 25% treatment was continued.The operator of humapen ergo ii and his/her training status was not provided.The general humapen ergo ii model duration was not provided but the suspect humapen ergo ii was started in aug-2019.The status of humapen ergo ii was unknown and its return was unknown.The initial reporting consumer did not provide an opinion of relatedness between the event and insulin lispro protamine suspension 75%/insulin lispro 25% treatment or humapen ergo ii.Update 16-oct-2020: both documents received on 14-oct-2020 were processed at same time.Edit 22-oct-2020: upon review of the initial information, the information regarding humapen ergo ii age was updated in narrative.Edit 27oct2020: updated medwatch fields for expedited device reporting.No new information added.Update 17nov2020: additional information received on 17nov2020 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 pc (b)(4) associated with unknown lot number of humapen ergo ii device.Upon internal review added device age.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: 10730617
• MDR Text Key: 216663420
• Report Number: 1819470-2020-00149
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR