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

Model Number MS9557

Device Problem Mechanical Problem (1384)

Patient Problem Hyperglycemia (1905)

Event Date 05/25/2022

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 patient support program (psp), concerned an 40-year-old asian male patient.Medical history included brain problem since 2012.Concomitant medications were not provided.The patient received human insulin (rdna) injections (huminsulin r) from cartridge, via a reusable pen humapen ergo ii, 30 units twice daily, subcutaneously, for the treatment of diabetes mellitus, beginning in (b)(6) 2022.During human insulin therapy, around (b)(6) 2022 approximately (reported 20 days back as of (b)(6) 2022) his blood sugar level was increased up to 600 mg/dl, due to which he was hospitalized.He was discharged after ten days (around (b)(6) 2022), after discharged his fasting blood sugar (fbs) was between 100 to 150mg/dl but his post prandial blood sugar (ppbs) was always increased.It was around 300-400mg/dl.Reportedly he felt giddiness and pain in legs when his blood sugar level increased.It was also reported that, humapen ergo ii was hard from last one week ((b)(4), lot number unknown).He was taking human insulin from syringe.Information regarding corrective treatment was not provided.Outcome of blood sugar increased (first clinical episode) was resolving while for remaining events was not recovered.Human insulin therapy was continued.The operator of the humapen ergo ii and his/her training status was unknown.The general humapen ergo ii device model duration of use and the suspect humapen ergo ii duration of use were not provided.Action taken with the suspect humapen was unknown and the device was not returned to the manufacturer.The initial reporting consumer did not know if the events were related to human insulin therapy and humapen ergo ii.Edit 27jun2022: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new medically significant information added.Edit 27jun2022: upon review, added pc number to the narrative text.No new medically significant information added.Update 30jun2022: additional information received on 29jun2022 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ (b)(4) device information for (b)(4) associated with unknown lot number of humapen ergo ii.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statements.Please refer to update statement (s) dated 30jun2022 in the event field.No further follow-up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device "was hard" (specific issue unknown).The patient experienced increased blood glucose about 20 days prior to the reported device issue.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.

• 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: 14880528
• MDR Text Key: 295126655
• Report Number: 1819470-2022-00050
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian