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

Model Number MS9673A

Device Problem Air Leak (1008)

Patient Problem Hyperglycemia (1905)

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 and a product complaint, concerns a male patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (humalog) cartridge, unknown dose, frequency, route of administration, indication for use and start date.On an unspecified date, unknown time after commencing treatment with insulin lispro via humapen luxura hd, patient was hospitalized due to an unclear reason and during the hospitalization, mother of patient was applying insulin lispro but the glycemia was getting high and patient needed to receive insulin intravenous.The event of high glycemia was considered serious by the company due to intervention required reason.The outcome was not provided.Due to this event, patients physician increased the dosage and stated that glycemia was getting high because humapen luxura hd (lot 1312g01) had a lot of bubbles air and was not injecting the correct dose ((b)(4)).Reporting consumer also stated that if the bubbles air were not removed, the correct dosage was not applied.Besides, it was also reported that in-use cartridge of insulin lispro and the device were stored on the refrigerator; the needles were reused around three times; the device was stored with the needle attached.Information regarding laboratory exams was not provided.Status of insulin lispro was unknown.Mother of patient was the operator of device but it was unknown if she was trained.The duration of use for this device model and the duration of use for this specific device were not reported.Status and return status of device were unknown.Reporting consumer did not provided an opinion of relatedness.Update 10jan20174: upon review, this case was opened to update the medwatch fields for regulatory reporting.Edit 11jan2017: upon internal review, the case was unlocked in order to correct preliminary comments.

Manufacturer Narrative

No further follow up is planned.Evaluation summary the mother of a patient reported that her child's humapen luxura hd device was not injecting the correct amount of insulin.She also stated that she had been discarding too much insulin when trying to remove the bubbles from inside the cartridge.The mother said the device was stored in the refrigerator with a needle attached and needles were reused.The patient experienced increased blood glucose.The device was not returned for investigation (batch 1312g01, manufactured december 2013).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the batch did not identify any atypical findings with regard to dose accuracy.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.The instructions for use (ifu) state "to prevent air from entering the cartridge, do not store the pen with a needle attached." it also states, "use a new needle for each injection.This will help ensure sterility.It will also help prevent leakage of insulin, keep out air bubbles, and reduce needle clogs." there is evidence of improper use.The patient reused needles and stored the device with a needle attached.The needle reuse and storage of the device with a needle attached may be relevant to the complaint of increased blood glucose.

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 a male patient of unknown age and ethnicity.Medical history and concomitant medications were not provided.The patient received insulin lispro (humalog) cartridge, unknown dose, frequency, route of administration, indication for use and start date.On an unspecified date, unknown time after commencing treatment with insulin lispro via humapen luxura hd, patient was hospitalized due to an unclear reason and during the hospitalization, mother of patient was applying insulin lispro but the glycemia was getting high and patient needed to receive insulin intravenous.The event of high glycemia was considered serious by the company due to intervention required reason.The outcome was not provided.Due to this event, patients physician increased the dosage and stated that glycemia was getting high because humapen luxura hd (lot 1312g01) had a lot of bubbles air and was not injecting the correct dose (pc (b)(4)).Reporting consumer also stated that if the bubbles air were not removed, the correct dosage was not applied.Besides, it was also reported that in-use cartridge of insulin lispro and the device were stored on the refrigerator; the needles were reused around three times; the device was stored with the needle attached.Information regarding laboratory exams was not provided.Status of insulin lispro was unknown.Mother of patient was the operator of device but it was unknown if she was trained.The duration of use for this device model and the duration of use for this specific device were not reported.The device was not returned.Reporting consumer did not provided an opinion of relatedness.Update 10jan20174: upon review, this case was opened to update the medwatch fields for regulatory reporting.Edit 11jan2017: upon internal review, the case was unlocked in order to correct preliminary comments.Update 24jan2017: additional information received on 23jan2017 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 european and canadian required device reporting elements; 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: 6266621
• MDR Text Key: 65415881
• Report Number: 1819470-2017-00007
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 1312G01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• 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: HUMALOG
• Patient Outcome(s): Required Intervention