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

Model Number MS9673

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Hyperglycemia (1905); Itching Sensation (1943); Therapeutic Response, Decreased (2271)

Event Date 01/31/2013

Event Type  Injury  

Event Description

Lilly case id: (b)(4).This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and a product complaint, concerns an adolescent female patient born in 2000 of unknown age and ethnicity.Medical history included type ii diabetes mellitus diagnosed in 2013 and hospitalization for eight days due to blood glucose increased at 550mg/dl.Concomitant medication was not provided.The patient received human insulin (rdna) nph (humulin n), cartridge; 30iu before breakfast, 10 iu before lunch, 10 iu before dinner; three times a day; subcutaneously; indicated for diabetes mellitus type i, starting in 2013.In addition, the patient also received human insulin (rdna origin) regular, cartridge; 2iu before breakfast, 2 iu before lunch and 2iu before dinner; three times a day; subcutaneously, indicated for diabetes mellitus type i, starting in 2013.It was reported that human insulin nph and human insulin regular were delivered via humapen luxura champagne (batch number 1207b05) and humapen luxura hd (batch number 110g03), however, it was unclear which insulin was delivered in each device pen.On an unreported date, according to the reporting consumer since when the patient started treatment with human insulin nph and human insulin regular in 2013, the patient could not control her blood glucose; it did not reach the value of 100 mg/dl and both insulins were not doing any effect.The least that her blood glucose reached was 150 mg/dl and due to that the patient had been going to the treating physician every week.The reporting consumer stated that sometimes the patient s blood glucose ranged a value of 300mg/dl, and as corrective treatment, both insulin doses were increased (new dose was not provided); however, it also did not have effect (when it has occurred, the patient was using two cartridges of human insulin nph with batch number c290477d and human insulin regular with batch number c290475c).Moreover, according to the reporter, the patients physician said that she was at risk of fainting and not coming back, due to the high blood glucose, and sent her to another physician.The event of high blood glucose was considered life-threatening by the reporter.Information regarding laboratorial investigations was not provided.The patient did not recover from high blood glucose and lack of efficacy.In addition, since (b)(6) 2015, approximately two years after starting treatment with human insulin nph and human insulin regular, the patient has experienced redness and an intense itching in belly (injection site area).The patient did not receive any corrective treatment and did not recover from redness and itching.It was provided that the patient reused her needles twice, nevertheless, she stored the pen device at room temperature, waited more than five second prior to removing the needle from the skin and injected the insulins in the arm and belly.The treatment with human insulin nph and human insulin regular was continued.The patient operated the device and she was trained by a nurse.The humapen luxura champagne and humapen luxura hd and the reported devices have been used for two years.There was no reported complaint for these devices and return is not expected.The reporting consumer related the event of lack of efficacy, not controlled blood glucose/ high blood glucose to human insulin nph and human insulin regular and the reporter did not provide other relatedness opinion.Also, the reporter did not assess a relatedness opinion regarding the events to devices.Update 27may2015: additional information received on 25may2015 from initial reporting consumer.Added a second reporter consumer, patients address, and human insulin nph lot number.No medically significant information was added to the case.

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.

Manufacturer Narrative

(b)(4).No further follow up is planned.Evaluation summary the patient experienced high blood sugars that could not be controlled while using a humapen luxura hd device (reported lot number 110g03).There was no product complaint for the device and the device was not returned for investigation.There was evidence of improper use of the device.It was reported that the patient re-used each needle twice.This is likely not relevant given that there was no product complaint relative to pen function.The device user manual indicates a new needle should be used with each injection.

Event Description

(b)(4).This spontaneous case, reported by a consumer, who contacted the company to report an adverse event and a product complaint, concerns an adolescent female patient born in 2000 of unknown age and ethnicity.Medical history included type ii diabetes mellitus diagnosed in 2013 and hospitalization for eight days due to blood glucose increased at 550mg/dl.Concomitant medication was not provided.The patient received human insulin (rdna) nph (humulin n), cartridge; 30iu before breakfast, 10 iu before lunch, 10 iu before dinner; three times a day; subcutaneously; indicated for diabetes mellitus type i, starting in 2013.In addition, the patient also received human insulin (rdna origin) regular, cartridge; 2iu before breakfast, 2 iu before lunch and 2iu before dinner; three times a day; subcutaneously, indicated for diabetes mellitus type i, starting in 2013.It was reported that human insulin nph and human insulin regular were delivered via humapen luxura champagne (batch number 1207b05) and humapen luxura hd (batch number 110g03), however, it was unclear which insulin was delivered in each device pen.On an unreported date, according to the reporting consumer since when the patient started treatment with human insulin nph and human insulin regular in 2013, the patient could not control her blood glucose; it did not reach the value of 100 mg/dl and both insulins were not doing any effect.The least that her blood glucose reached was 150 mg/dl and due to that the patient had been going to the treating physician every week.The reporting consumer stated that sometimes the patients blood glucose ranged a value of 300mg/dl, and as corrective treatment, both insulin doses were increased (new dose was not provided); however, it also did not have effect (when it has occurred, the patient was using two cartridges of human insulin nph with batch number c290477d and human insulin regular with batch number c290475c).Moreover, according to the reporter, the patients physician said that she was at risk of fainting and not coming back, due to the high blood glucose, and sent her to another physician.The event of high blood glucose was considered life-threatening by the reporter.Information regarding laboratorial investigations was not provided.The patient did not recover from high blood glucose and lack of efficacy.In addition, since (b)(6) 2015, approximately two years after starting treatment with human insulin nph and human insulin regular, the patient has experienced redness and an intense itching in belly (injection site area).The patient did not receive any corrective treatment and did not recover from redness and itching.It was provided that the patient reused her needles twice, nevertheless, she stored the pen device at room temperature, waited more than five second prior to removing the needle from the skin and injected the insulins in the arm and belly.The treatment with human insulin nph and human insulin regular was continued.The patient operated the device and she was trained by a nurse.The humapen luxura champagne and humapen luxura hd and the reported devices have been used for two years.The device was not returned.The reporting consumer related the event of lack of efficacy, not controlled blood glucose/ high blood glucose to human insulin nph and human insulin regular and the reporter did not provide other relatedness opinion.Also, the reporter did not assess a relatedness opinion regarding the events to devices.Update 27may2015: additional information received on 25may2015 from initial reporting consumer.Added a second reporter consumer, patient s address, and human insulin nph lot number.No medically significant information was added to the case.Update 30jun2015: additional information received on 29jun2015 from the global product complaint database added the device specific safety summary; added the device was not returned; 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-ORIGEN; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 4839993
• MDR Text Key: 18874471
• Report Number: 1819470-2015-00040
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9673
• Device Lot Number: 110G03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2015
• 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
• Treatment: HUMULIN
• Patient Outcome(s): Life Threatening
• Patient Age: 14 YR