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

Model Number MS9557

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bronchitis (1752); High Blood Pressure/ Hypertension (1908)

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

(b)(4) this spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) asian male patient.Medical history included hypertension, renal disease, bronchitis and cardio-cerebrovascular disease.Concomitant medications included acarbose and gliclazide for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25) formulation: cartridge, via humapen ergo ii, 24 iu (with conflicting information received reported as of 22 iu at morning), and 20 iu at night, subcutaneously, for treatment of diabetes mellitus beginning in (b)(6) 2015.On (b)(6) 2016 he was hospitalized to regulate blood glucose and blood pressure; he was discharged on (b)(6) 2016.On (b)(6) 2016 his humapen ergo ii had a failure (product complaint 3565332/lot 1404d03) and did not injected insulin lispro protamine suspension 75%/insulin lispro 25%.He changed to unspecified oral medicine to decreased blood glucose.No further details were reported.Action taken with insulin lispro protamine suspension 75%/insulin lispro 25% was not reported.It was unknown if the patient was a trained user of the device.The patient had used humapen ergo ii devices for about seven months.It was unknown how long the suspect device was used.Use of the device was discontinued.The reporting consumer did not know if there was relatedness between the events and insulin lispro protamine suspension 75%/insulin lispro 25%.Update 08-feb-2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements; add the product complaint number; and update the narrative.

Manufacturer Narrative

(b)(4).No further follow up is planned.Evaluation summary: a male patient reported that his humapen ergo ii device was not delivering insulin.The investigation of the returned device (batch 1404d03, manufactured april 2014) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications.No malfunction was identified.There is no evidence of improper use.

Event Description

Lilly case id: (b)(6).This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) asian male patient.Medical history included hypertension, renal disease, bronchitis and cardio-cerebrovascular disease.Concomitant medications included acarbose and gliclazide for unknown indication.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix 25) formulation: cartridge, via humapen ergo ii, 24 iu (with conflicting information received reported as of 22 iu at morning), and 20 iu at night, subcutaneously, for treatment of diabetes mellitus beginning in (b)(6) 2015.On (b)(6) 2016 he was hospitalized to regulate blood glucose and blood pressure; he was discharged on (b)(6) 2016.On (b)(6) 2016 his humapen ergo ii had a failure (product complaint (b)(4)/lot 1404d03) and did not injected insulin lispro protamine suspension 75%/insulin lispro 25%.He changed to unspecified oral medicine to decreased blood glucose.No further details were reported.Action taken with insulin lispro protamine suspension 75%/insulin lispro 25% was not reported.It was unknown if the patient was a trained user of the device.The patient had used humapen ergo ii devices for about seven months.It was unknown how long the suspect device was used.The device was returned 01feb2016, and no malfunction was found.The reporting consumer did not know if there was relatedness between the events and insulin lispro protamine suspension 75%/insulin lispro 25%.Update 08-feb-2016: upon review, this case was opened to update the medwatch and european and (b)(6) required device reporting elements; add the product complaint number; and update the narrative.Edit 23-feb-2016: upon internal review (b)(4) received on 29-jan-2016 was already processed.No other changes performed.Update 29-feb-2016: additional information received on 29-feb-2016 from the global product complaint database added the device specific safety summary, manufactured date, and return date of the device; updated the malfunction to no; updated the medwatch and european and (b)(6) required device reporting elements; and updated the narrative.

• 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: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5433406
• MDR Text Key: 38092222
• Report Number: 1819470-2016-00030
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Device Lot Number: 1404D03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• 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
• Treatment: ACARBOSE
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 80