MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY; FOR TREATMENT PURPOSES

Model Number MS9662

Device Problems Break (1069); Defective Component (2292); Noise, Audible (3273)

Patient Problems Fainting (1847); Hematoma (1884); Hemorrhage/Bleeding (1888); Hyperglycemia (1905); Hypoglycemia (1912)

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 with additional information provided by the same consumer via a patient support program (psp), who contacted the company to report adverse events and a product complaint, concerns a (b)(6) male patient.Medical history was not provided.Concomitant medications included insulin glargine for unknown indication.The patient received insulin lispro (humalog), cartridge, dose according to his glycaemia (for each 50mg/dl took 1iu of insulin lispro - reference value 100mg/dl; generally took 4iu for each meal and if he did some physical activity at night he did not use insulin lispro), subcutaneously, for treatment of type 1 diabetes mellitus, beginning more than 10 years before initial report.On a non-reported date, unknown time after starting treatment with insulin lispro and unknown if prior or after starting the use of humapen luxura burgundy (lot 1209b06), patient had several cases of hypoglycemia and hyperglycemia; in one of the cases of hypoglycemia, patient fainted.It was also stated by the reporter that the patient injected the medication before the meals and sometimes he took a while to eat after the injection, so his glycaemia dropped and he presented hypoglycemia.The event of hypoglycemia followed by fainting was considered serious due to medically significant reason by the company.No information of corrective treatment and outcome of the events were provided.It was also provided that sometimes a few hematomas appeared at the injection sites and blood came out; the patient used the needle of 12mm in an angle of 90 degrees.No information of corrective treatment and outcome for injection site hematoma and injection site bleeding was provided.On (b)(6) 2016, approximately one year (also reported as one and a half year) after beginning treatment with insulin lispro via humapen luxura burgundy, the device was defective; the injection screw was broken, the device was just making a little noise and was not injecting insulin (associated with product (b)(4)).Due to that, the patients glycaemia reached 400 mg/dl and 500mg/dl (reference range was not provided).As corrective treatment, the patient bought a disposable pen of insulin lispro in the drugstore.Information regarding outcome for the event was not provided.It was reported that the patient only performed the priming when a new cartridge was started.Insulin lispro treatment status was unknown.The patient was the operator of the device and he was not trained.This device model was used for about 10 years and the reported device was used for about one year.It was unknown if the use of humapen luxura burgundy was continued.The return of the device was expected.The reporting consumer stated that the event of blood glucose increased was not related to insulin lispro, however, it was related to the defective device.No other relatedness opinion was provided.Update 19aug2016: additional information received from initial reporting consumer on 18aug2016.Added patient support program as a reporter tab.Added serious event of hypoglycemia followed by fainting and non-serious events of hyperglycemia, hypoglycemia, injection site hematoma and injection site bleeding.Added information that it was unknown if the use of humapen luxura burgundy was continued.Added another patient s phone number.Narrative and corresponding fields were updated accordingly.Update the narrative edit 23aug2016.Case was opened to enter the medwatch device fields for device mailing.No new information.

Manufacturer Narrative

Narrative; new updated and corrected information is referenced within the update statements in narrative.Please refer to statement dated 21sep2016 in the narrative.Evaluation summary a male patient reported while using his humapen luxura device that it was defective, the injection screw was broken, the device was making a noise and it was not injecting insulin.He experienced hypoglycemic unconsciousness.The investigation of the returned device (batch (b)(4), manufactured september 2012) found glass remnants inside the housing and on the injection screw.Additionally, a brown foreign material was observed in the device.The injection force was found to be high.The investigation determined that the mechanical difficulties experienced by the user were due to the glass remnants and the foreign material in the device.Malfunction confirmed.A complaint history review of this batch did not identify any atypical trends with regard to device not working.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with a high probability.The patient only primed with a new cartridge.The user manual instructs the patient to prime the device using 2 units before every injection until insulin is seen at the needle tip.The user manual also states that the injection button may become harder to push if the inside of the pen gets dirty with insulin, food, drink or other materials.Following the care and storage instructions should help prevent this.There is evidence of improper use.The user did not prime the device before each injection.There was also foreign material inside the device.These issues were not likely relevant to the event of hypoglycemia unconsciousness.

Event Description

(b)(4).This spontaneous case reported by a consumer with additional information provided by the same consumer via a patient support program (psp), who contacted the company to report adverse events and a product complaint, concerns a (b)(6) male patient.No relevant medical history.Concomitant medications included insulin glargine and insulin degludec for unknown indication.The patient received insulin lispro (humalog), cartridge, dose according to his glycaemia (for each 50mg/dl took 1iu of insulin lispro - reference value 100mg/dl; generally took 4iu for each meal and if he did some physical activity at night he did not use insulin lispro), subcutaneously, for treatment of type 1 diabetes mellitus, beginning more than 10 years before initial report.On a non-reported date, unknown time after starting treatment with insulin lispro and unknown if prior or after starting the use of humapen luxura burgundy patient had several cases of hypoglycemia and hyperglycemia, the hyperglycemia reached 450 and the hypoglycemia reached 32 and 45; in one of the cases of hypoglycemia, patient fainted.It was also stated by the reporter that the patient injected the medication before the meals and sometimes he took a while to eat after the injection, so his glycaemia dropped and he presented hypoglycemia, and also that every week the patient presented hypoglycemia at least once and that he no longer felt the symptoms, he only verified the value of glycaemia.The event of hypoglycemia followed by fainting was considered serious due to medically significant reason by the company.The patient injected unspecified ultra-rapid insulin when he presented hyperglycemia and he ate when he had hypoglycemia; during the jogging, the patient made use of unspecified product; however when the patient fed himself as a corrective treatment, he ended up having hyperglycemia due to compensation (as reported).The outcome of the event hyperglycemia was not provided.It was stated by the reporter that no change in the treatment regimen and no event potentially associated to hyperglycemia occurred prior to the events of hypoglycemia and hyperglycemia; the patient s physician was informed about the events and tried to regulate the dose of the insulins.It was also provided that sometimes a few hematomas appeared at the injection sites and blood came out; the patient used the needle of 12mm in an angle of 90 degrees.No information of corrective treatment and outcome for injection site hematoma and injection site bleeding was provided.On (b)(6) 2016, approximately one year (also reported as one and a half year) after beginning treatment with insulin lispro via humapen luxura burgundy, the device was defective; the injection screw was broken, the device was just making a little noise and was not injecting insulin (lot 1209b06/ (b)(4)).Due to that, the patients glycaemia reached 400 mg/dl and 500mg/dl (reference range was not provided).As corrective treatment, the patient bought a disposable pen of insulin lispro in the drugstore.Information regarding outcome for the event was not provided.During the week of (b)(6) 2016, patient had another hypoglycemia episode; the reporter stated that the glycemic variation of a diabetic patient was very intense.It was stated by the reporter that the patient used to do physical activities three to four times a week, which included jogging and bodybuilding.It was reported that the patient only performed the priming when a new cartridge was started.Insulin lispro treatment status was unknown.The patient was the operator of the device and he was not trained.This device model was used for about 10 years and the reported device was used for about one year.It was unknown if the use of humapen luxura burgundy was continued.Device returned 16aug2016.A brown foreign material was observed in the device.The injection force was found to be high.The reporting consumer stated that the event of blood glucose increased was not related to insulin lispro, however, it was related to the defective device.No other relatedness opinion was provided.Update 19aug2016: additional information received from initial reporting consumer on 18aug2016.Added patient support program as a reporter tab.Added serious event of hypoglycemia followed by fainting and non-serious events of hyperglycemia, hypoglycemia, injection site hematoma and injection site bleeding.Added information that it was unknown if the use of humapen luxura burgundy was continued.Added another patient s phone number.Narrative and corresponding fields were updated accordingly.Update the narrative edit 23aug2016.Case was opened to enter the medwatch device fields for device mailing.No new information.Update 21sep2016.Additional information received 20sep2016 from the product complaint safety database.To the device tab added the device specific safety summary (dsss), date of return, manufacture date, approximate device age, changed malfunction to yes, malfunction type to not a company identified reportable malfunction (cirm),updated the european and canadian (eu/ca) device information, updated the device medwatch information, and the narrative was updated accordingly.Update 30sep2016: additional information received from initial reporting consumer on 28sep2016.Added concomitant medication insulin degludec and unspecified insulin ultra-rapid as treatment drug.Updated as reported of events hyperglycemia and hypoglycemia to add information that hyperglycemia reached 450 and the hypoglycemia reached 32 and 45; updated treatment received of both events to yes.Updated outcome of hypoglycemia to not recovered; since it was stated that patient had hypoglycemia at least once a week.Added information that no change in the treatment regimen and no event potentially associated to hyperglycemia occurred prior to the events of hypoglycemia and hyperglycemia; the patient s physician was informed about the events and tried to regulate the dose of the insulins.Also added that another episode of hypoglycemia occurred during the week of (b)(6) 2016 and that the patient used to do physical activities three to four times a week, which included jogging and bodybuilding.Added information that patient had no medical history.Narrative and corresponding fields were updated accordingly.

• Brand Name: HUMAPEN LUXURA BURGUNDY
• 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: 5939505
• MDR Text Key: 54406789
• Report Number: 1819470-2016-00229
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K142518
• 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: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9662
• Device Lot Number: 1209B06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2012
• 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: HUMALOG LISPRO; LANTUS
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 78