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

Model Number MS9557

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); 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 report is associated with product (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerns a (b)(6) asian male patient.Medical history included hypertension.Concomitant medications included metformin and acarbose for unspecified indications.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from a cartridge via a reusable pen (humapen ergo 2), 20 unspecified units in the morning and at night subcutaneously, for the treatment of diabetes mellitus, beginning in (b)(6)2015.In (b)(6) 2015, the button of the humapen ergo ii had an unspecified problem (product (b)(4)/lot 1203d01).Approximately one year after starting human insulin 70/30, on (b)(6) 2016, he was hospitalized due to hyperglycemia and hypertension.Information regarding corrective treatment and outcome of the events was not provided.As of (b)(6) 2016, he was still hospitalized.Human insulin 70/30 continued.The operator of the humapen ergo 2 and his/her training status were not reported.The general duration of use of humapen ergo 2 was not provided but it started in (b)(6) 2015.The duration of use of suspect humapen ergo 2 was not reported.If humapen ergo 2 was returned, evaluation would be performed.The reporting consumer did not know if the event was related to human insulin 70/30 and did not provide any opinion of relatedness between hyperglycemia and humapen ergo 2.Update 28-jan-2016: upon review, this case was opened to update the medwatch fields for regulatory reporting; updated the european and canadian required device reporting elements; added the product complaint description to the narrative with the product (b)(4); and updated the narrative.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a male patient reported the injection button on his humapen ergo ii could not be pushed down.He experienced hyperglycemia.The device was not returned to the manufacturer for investigation (batch 1203d01, manufactured march 2012).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 trends with regard to dose accuracy.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), with additional information form the initial reporter, concerned a (b)(6) male patient.Medical history included hypertension.Concomitant medications included metformin and acarbose for unspecified indications.The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) (humulin 70/30) from a cartridge via a reusable pen (humapen ergo 2), 20 unspecified units in the morning and at night subcutaneously, for the treatment of diabetes mellitus, beginning in (b)(6) 2015.In (b)(6) 2015, the button of the humapen ergo ii had an unspecified problem ((b)(4)/lot 1203d01).Approximately one year after starting human insulin 70/30, on (b)(6) 2016, he was hospitalized due to hyperglycemia and hypertension.It was reported that the patient was not compliant with diet recommendations and prescribed medications.Information regarding corrective treatment was not provided.As of (b)(6) 2016, he was still hospitalized.As of (b)(6) 2016 he was recovering from the events.Human insulin 70/30 continued.The operator of the humapen ergo 2 and his/her training status were not reported.The general duration of use of humapen ergo 2 was not provided but it started in (b)(6) 2015.The duration of use of suspect humapen ergo 2 was not reported.The humapen ergo 2 was not returned.The reporting consumer did not know if the event (hypertension) was related to human insulin 70/30 and did not provide any opinion of relatedness between hyperglycemia and humapen ergo 2.Update 28-jan-2016: upon review, this case was opened to update the medwatch fields for regulatory reporting; updated the (b)(6) required device reporting elements; added the product complaint description to the narrative with the product complaint (b)(4); and updated the narrative.Update 08-feb-2016: additional information received from the initial reporter via a psp on 03-feb-2016.Updated outcome of the events.Updated narrative with new information.Edit 18-feb-2016: product complaint (pc) was received from psp on 25-jan-2016.No new information was added to the case, since pc was already processed.Update 24-feb-2016: additional information received on 23-feb-2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the medwatch 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: 5409641
• MDR Text Key: 37429879
• Report Number: 1819470-2016-00020
• 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: 01/21/2016

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?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2012
• 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: METFORMIN
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 109