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

Model Number MS9557

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There was no reported complaint for this device and its return is not expected.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

(b)(4).This report is associated with product compliant: pending.This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of (b)(6) nationality.Medical history included constipation, high urine protein and mother and brother had diabetes.Concomitant medication included metformin taking since 1998 for type 2 diabetes mellitus.The patient received insulin lispro protamine suspension 50%/insulin lispro 50% (rdna origin) injections (humalog 50, 100 u/ml) via a cartridge with reusable device humapen ergo ii (started in (b)(6) 2018), twice daily, 28 iu units in morning and 18 iu in evening, subcutaneously, for the treatment of diabetes mellitus type 2, started therapy in (b)(6) 2018.Since an unknown date after starting insulin lispro protamine suspension 50%/insulin lispro 50% he had experiencing unstable blood sugar (values were not provided).In (b)(6) 2018, the dosage of insulin lispro protamine suspension 50%/insulin lispro 50% was adjusted to 30 units in the morning and 22 units in the evening according to the doctor advice.Because of unstable blood sugar, he was hospitalized twice in (b)(6) 2018 and (b)(6) 2018, respectively.In the beginning of (b)(6) 2018, the dose of insulin lispro protamine suspension 50%/insulin lispro 50% was adjusted to 26 units in the morning and 18 units in the morning according to the doctor advice.He had been discharged from hospital.Corrective treatment and outcome of the event was not provided.Therapy with insulin lispro protamine suspension 50%/insulin lispro 50% was ongoing.The user of the humapen ergo ii was unknown and his/ her training status was not provided.The humapen ergo ii general device durations of use and the suspect humapen ergo ii device durations of use were not reported.The suspect humapen ergo ii was continued and its return was not possible.The reporting consumer did not relate the event with insulin lispro protamine suspension 50%/insulin lispro 50% therapy did not provide relatedness with humapen ergo ii.

• 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): 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: 7899216
• MDR Text Key: 121437914
• Report Number: 1819470-2018-00163
• 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
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• 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: 08/28/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 66 YR
• Patient Weight: 85