MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problem Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Underdose (2542)

Event Date 09/17/2015

Event Type  malfunction  

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 solicited case, reported by a consumer who contacted the company to report an adverse event with a product complaint, with additional information provided by a nutritionist from a patient support program (psp), concerns a (b)(6) female patient of unknown origin.The medical history of patient included use of insulin glulisine for diabetes type 1 which was discontinued due to allergy.The concomitant medication included insulin degludec and vildagliptin both for unknown indications.The patient received insulin lispro (humalog) cartridge via humapen luxura half-dose, dose in accordance to carbohydrates counting (also described as used for correction), subcutaneously, for the treatment of diabetes type 1, beginning in (b)(6) 2015.On (b)(6) 2015, approximately two months after the starting of insulin lispro via reusable pen, the patient experienced episodes of hyperglycemia because the humapen luxura half-dose (lot number 1210g01) was not releasing the insulin dose.The patient also experienced burning, pain and hematomas described as purple in the application site on her leg and she also had blister in this site.According to reporting consumer these events occurred because the pen was making bubbles (as reported) and they worsened if the patient practiced swimming.The patient did not receive corrective treatment for these events and the physician instructed to apply nothing on the leg.On an unspecified date, unknown time after the starting of insulin lispro via reusable pen, the patient lost 1.750 kg during five days and her mother visited the physician who considered it strange (as reported) because the patient was eating correctly and stated to the mother that it could be related to the pen.Information regarding corrective treatment was not provided.On an unknown date the glycemia of patient was 600 (measure unit was not provided).As corrective treatment her mother increased the insulin dose to 14 iu which used to be between 2 and 5 iu and she also received vildagliptin.The increased dose of insulin lispro was delivered via humapen luxura burgundy and it worked perfectly.The event of hyperglycemia was considered serious by the company due to medically significant reason.According to reporting consumer the injection screw of humapen luxura half-dose touched the cartridge and it moved but the insulin was not released.On (b)(6) 2015 the mother of patient almost sent her to hospital but she did not do it because it was found out that the problem was the pen (as reported).Information regarding outcome of weight loss and drug dose omission was not provided.The patient was recovering from the hyperglycemia and she did not recover from the events of injection site pain, hematoma and blister.The humapen luxura half-dose was associated with the product (b)(4).Treatment with insulin lispro was continued.The patient operated the device and she was trained by a company representative.The patient had used the device model for two years and the reported device for two months.The device return was expected.If device is returned, evaluation will be performed to determine if a malfunction has occurred.The reporting nutritionist did not provide a relatedness opinion.The reporting consumer did not provide a relatedness opinion for the event of weight loss and considered the remaining events not related to the insulin lispro but related to the problem of humapen luxura half-dose.Update 30sep2015: additional information received on 24sep2015 from initial reporter via a nutritionist from a psp was processed with initial report.Update 30sep2015: upon review, this case was opened to updated the medwatch fields for regulatory reporting.Edit 07oct2015: upon internal review on 07oct2015 it was performed non-medically significant edit in order to include in the narrative the product complaint number regarding the device humapen luxura half-dose.

Manufacturer Narrative

No further follow up is planned.Evaluation summary: a female patient reported that her humapen luxura hd device "was not releasing the insulin dose." she experienced hyperglycemia.The investigation of the returned device (batch 1210g01, manufactured october 2012) 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 or storage.

Event Description

Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer who contacted the company to report an adverse event with a product complaint, with additional information provided by a nutritionist from a patient support program (psp), concerns a (b)(4) old female patient of unknown origin.The medical history of patient included use of insulin glulisine for diabetes type 1 which was discontinued due to allergy.The concomitant medication included insulin degludec and vildagliptin both for unknown indications.The patient received insulin lispro (humalog) cartridge via humapen luxura half-dose, dose in accordance to carbohydrates counting (also described as used for correction), subcutaneously, for the treatment of diabetes type 1, beginning in (b)(6) 2015.On (b)(6) 2015, approximately two months after the starting of insulin lispro via reusable pen, the patient experienced episodes of hyperglycemia because the humapen luxura half-dose (lot number 1210g01) was not releasing the insulin dose.The patient also experienced burning, pain and hematomas described as purple in the application site on her leg and she also had blister in this site.According to reporting consumer these events occurred because the pen was making bubbles (as reported) and they worsened if the patient practiced swimming.The patient did not receive corrective treatment for these events and the physician instructed to apply nothing on the leg.On an unspecified date, unknown time after the starting of insulin lispro via reusable pen, the patient lost 1.750 kg during five days and her mother visited the physician who considered it strange (as reported) because the patient was eating correctly and stated to the mother that it could be related to the pen.Information regarding corrective treatment was not provided.On an unknown date the glycemia of patient was 600 (measure unit was not provided).As corrective treatment her mother increased the insulin dose to 14 iu which used to be between 2 and 5 iu and she also received vildagliptin.The increased dose of insulin lispro was delivered via humapen luxura burgundy and it worked perfectly.The event of hyperglycemia was considered serious by the company due to medically significant reason.According to reporting consumer the injection screw of humapen luxura half-dose touched the cartridge and it moved but the insulin was not released.On (b)(6) 2015 the mother of patient almost sent her to hospital but she did not do it because it was found out that the problem was the pen (as reported).Information regarding outcome of weight loss and drug dose omission was not provided.The patient was recovering from the hyperglycemia and she did not recover from the events of injection site pain, hematoma and blister.The humapen luxura half-dose was associated with the product complaint (b)(4).Treatment with insulin lispro was continued.The patient operated the device and she was trained by a company representative.The patient had used the device model for two years and the reported device for two months.The device was returned on (b)(6) 2015, and no malfunction was found.The reporting nutritionist did not provide a relatedness opinion.The reporting consumer did not provide a relatedness opinion for the event of weight loss and considered the remaining events not related to the insulin lispro but related to the problem of humapen luxura half-dose.Update (b)(6) 2015: additional information received on (b)(6) 2015 from initial reporter via a nutritionist from a psp was processed with initial report.Update (b)(6) 2015: upon review, this case was opened to updated the medwatch fields for regulatory reporting.Edit (b)(6) 2015: upon internal review on (b)(6) 2015 it was performed non-medically significant edit in order to include in the narrative the product complaint number regarding the device humapen luxura half-dose.Update (b)(6) 2015: additional information received on (b)(6) 2015 from the global product complaint database added the device specific safety summary, return date of the device, and manufactured date of the device; updated the malfunction field to no; updated the medwatch and eu/ca fields; and updated the narrative.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• 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; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5136606
• MDR Text Key: 28256040
• Report Number: 1819470-2015-00099
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K063151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Followup
• Report Date: 09/24/2015

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: Lay User/Patient
• Device Model Number: MS9673A
• Device Lot Number: 1210G01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• 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
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Weight: 44