MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO TEAL/CLEAR; FOR TREATMENT PURPOSES

Model Number MS8929

Device Problems Loose or Intermittent Connection (1371); Inaccurate Delivery (2339); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated, and corrected information is referenced within the update statements.Please refer to update statement(s) dated (b)(6) 2021.No further follow-up is planned.Evaluation summary a male patient reported that the cartridge holder of his humapen ergo device would be pulled out when removing the pen cap.He also reported that "sometimes the injection button was stuck when pressed, a little worn, the pressing pressure was uneven and the dosage was not so stable when injected." he experienced abnormal blood glucose.The device was not returned to the manufacturer for investigation (batch 0407a02, manufactured july 2004).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical findings with regard to loose cartridge holder, dose accuracy, pen jam, or injection force uneven issues.While the patient reported obtaining the device in (b)(6) 2018, based on the amount of time elapsed since this device was manufactured (2004), it is likely that the device is beyond its approved use life.The user manual states the humapen ergo device has been designed to be used for up to 3 years after first use.Based on the information provided by the patient, 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 spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a male patient of unknown age and origin.Medical history included hypertension.Concomitant medication included metformin and acarbose; both for unknown indications.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix25) from a cartridge via reusable pen humapen ergo (teal/clear), at 20 units, twice a day, subcutaneously, for the treatment of diabetes mellitus, beginning sometime in (b)(6) 2018.Sometime in (b)(6) 2020, while on insulin lispro 75/25 treatment, he was hospitalized due to diabetes mellitus and the blood glucose was not well controlled (values, units and normal reference range not provided); which occurred due to the fault of injection pen humapen ergo like when the pen cap was pulled out, the humapen ergo cartridge holder would be pulled out together.Sometimes the injection button was stuck when pressed, a little worn, the pressing pressure was uneven and the dosage was not so stable when injected (incorrect dose administered)(pc number: (b)(4) and batch number: 0407a02).As of (b)(6) 2021, he was hospitalized.The information regarding corrective treatment and outcome for events was not provided.Insulin lispro 75/25 treatment was continued.No additional follow-up would be attempted as the reporter refused to be followed up via phone and no treating physician contact information was provided.The operator of the humapen ergo and his/her training status was not provided.The general humapen ergo model duration of use and the suspect humapen ergo model duration of use was approximately two years seven months.The humapen ergo (teal/clear),(lot number 0407a02) associated with product complaint (b)(4) was not returned to the manufacturer.The reporting consumer did not know if the event of blood glucose abnormal was related while did not provide any relatedness for the remaining event with insulin lispro 75/25 treatment.The reporting consumer did not provide any relatedness for the event of blood glucose abnormal while related the remaining event with its humapen ergo.Edit 22jan2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.01feb2021: additional information received on 28jan2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and (b)(6) (eu/(b)(6)) device information.Added date of manufacturer for the humapen ergo (teal/clear),(lot number 0407a02) device associated with product complaint (b)(4) which was not returned to the manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN ERGO TEAL/CLEAR
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 11266555
• MDR Text Key: 233301027
• Report Number: 1819470-2021-00014
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K982842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS8929
• Device Lot Number: 0407A02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2004
• 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