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

Model Number MS9557

Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Device Fell (4014)

Patient Problem Hyperglycemia (1905)

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), with additional information from the initial reporter via psp, concerned a (b)(6) year-old (at the time of initial report) male patient of unknown origin.Medical history and concomitant medication was not provided.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix 50) via cartridge via a reusable humapen ergo ii, of unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 1992.On an unknown date in 2013 or 2014, he was hospitalized due to an unknown reason where he was presented humapen ergo ii.Due to high blood glucose (units, values and reference ranges were not provided), every month he was hospitalized.The outcome of event, corrective treatment details and status of insulin lispro protamine suspension 50%/ insulin lispro 50% therapy were not provided.Follow up was not possible because contact details of treating physician was not provided and the reporter denied to be contacted.The operator of the humapen ergo ii and his/her training status was not provided.The general humapen ergo ii model duration was approximately seven or eight years (stated in 2013 or 2014) and the suspect humapen ergo ii duration of use was not provided.The action taken with the suspect humapen ergo ii and its return status was not provided.The initial reporting consumer did not provide the relatedness of event with insulin lispro protamine suspension 50%/ insulin lispro 50% therapy and with humapen ergo ii.Update 31-aug-2021: this case was determined to be non-valid as no valid identifiable adverse event was reported (hospitalization).Update 07-sep-2021: this case was initially determined to be non-valid (no valid identifiable event).Additional information was received from the initial reporter via psp on 02-sep-2021, which contained a valid serious event of high blood glucose (as reason for hospitalization).Added: laboratory test of blood glucose.Updated: humapen ergo ii from concomitant to suspect device and product complaint (pc) was reprocessed.Narrative was updated with new information accordingly.Edit 08sep2021: updated medwatch and european and (b)(6) fields for expedited device reporting.No new information added.

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), with additional information from the initial reporter via psp, concerned a 58-year-old (at the time of initial report) male patient of unknown origin.Medical history and concomitant medication was not provided.The patient received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix 50) via cartridge via a reusable humapen ergo ii, of unknown dose and frequency, subcutaneously, for the treatment of diabetes mellitus, beginning on an unknown date in 1992.On an unknown date in 2013 or 2014, he was hospitalized due to an unknown reason where he was presented humapen ergo ii.Due to high blood glucose (units, values and reference ranges were not provided), every month he was hospitalized.It was reported that the humapen ergo ii device was dropped and broken, the cartridge holder was loosed, it was not so good to be used during injection (pc number: 5700031/lot number: unknown).The outcome of event, corrective treatment details and status of insulin lispro protamine suspension 50%/ insulin lispro 50% therapy were not provided.Follow up was not possible because contact details of treating physician was not provided and the reporter denied to be contacted.The operator of the humapen ergo ii and his/her training status was not provided.The general humapen ergo ii model duration was approximately seven or eight years (stated in 2013 or 2014) and the suspect humapen ergo ii duration of use was not provided.The action taken with the suspect humapen ergo ii with pc 5700031 associated with an unknown lot number was not provided and it was not returned to manufacturer.The initial reporting consumer did not provide the relatedness of event with insulin lispro protamine suspension 50%/ insulin lispro 50% therapy and with humapen ergo ii.Update 31-aug-2021: this case was determined to be non-valid as no valid identifiable adverse event was reported (hospitalization).Update 07-sep-2021: this case was initially determined to be non-valid (no valid identifiable event).Additional information was received from the initial reporter via psp on 02-sep-2021, which contained a valid serious event of high blood glucose (as reason for hospitalization).Added: laboratory test of blood glucose.Updated: humapen ergo ii from concomitant to suspect device and product complaint (pc) was reprocessed.Narrative was updated with new information accordingly.Edit 08sep2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 30sep2021: additional information received on 27sep2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for pc 5700031 associated with unknown lot of humapen ergo ii device.Corresponding fields and narrative updated accordingly.

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 30sep2021 in the b.5.Field.No further follow-up is planned.Evaluation summary : a male patient reported on 27-aug-2021 that over one month ago, his humapen ergo ii device "was dropped and broken, the cartridge holder was loosed, it was not so good to be used during injection." he experienced increased blood glucose on numerous occasions.The device was not returned to the manufacturer for investigation (batch 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.The patient reported that he had used the device for seven or eight 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.The core instructions for use also state if any of the parts of your humapen ergo ii appear broken or damaged, do not use, and to contact lilly or your healthcare professional for a replacement pen.There is evidence of improper use.The patient continued to use the device after experiencing the alleged complaint issue and used the device beyond the recommended use period.It is unknown if the misuse is relevant to the event of increased blood glucose.

• 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: 12481564
• MDR Text Key: 271771406
• Report Number: 1819470-2021-00122
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR