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

Model Number MS9662

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Event: new, updated and corrected information is referenced within the update statements.Please refer to update statement dated 25sep2017.No further follow-up is planned.Evaluation summary: a physician reported, on behalf of a male patient, that the injection button of the patient's humapen luxura device was could not be pushed down.The patient experienced increased blood glucose.The device was not returned for investigation (batch 1107b05, manufactured july 2011).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 pen jams.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use and storage.

Event Description

Lilly case id: (b)(6).This report is associated with product compliant:(b)(4).This spontaneous case, reported by a physician who contacted the company to report an adverse event and a product complaint (pc), with additional information from the initial reporter and a consumer, concerned a (b)(6) male patient.Medical history was not provided.Concomitant medications included insulin glargine, metformin and a hypotensor (specific name not provided).The patient received an unspecified form of human insulin (rdna origin) injection (humulin) cartridge via reusable pen humapen luxura (burgundy) for the treatment of diabetes mellitus beginning in 2012.Dosage regimen, frequency, and route of administration were not provided.It was noted that the injection button of his humapen luxura (burgundy) could not be pushed down on an unknown date in (b)(6) 2017 (pc: 4104652/ lot: 1107b05).On an unreported date, he experienced itchy in the "tights", calves and profanity and high glucose; his fasting blood glucose was 14-15 and 17-18 two hours after meal (no units or reference values were provided for the above), so on (b)(6) 2017, he was hospitalized and human insulin treatment was discontinued.During hospitalization received unspecified treatment and was changed to an unspecified form of insulin lispro (rdna origin) injection (humalog) for the treatment of diabetes mellitus and beginning on (b)(6) 2017.Dosage regimen, frequency, and route of administration were not provided.On an unspecified date, but during hospitalization his blood glucose was still high and approximately on (b)(6) 2017 (12 days later) due to the glucose was still high.He left the hospital.Information regarding hospitalization dates were not provided.By (b)(6) 2017, his fasting blood glucose was 12-13 and about 16 two hours after meal (no units or reference values were provided for the above) and was using two kinds of insulin, one was insulin lispro (humalog) 8 units three times daily and the other specific name was unknown, injecting 30 before sleep.Information regarding corrective treatment, outcome of the events, and treatment status of insulin lispro was not provided.It was unknown if the treatment with human insulin would be restarted.The user of the humapen luxura (burgundy) device and her/his training status were not provided.The general model duration of use and the suspect model duration of use was approximately five years.The action taken with the humapen luxura (burgundy) was not provided.The suspect device, which was manufactured in jul 2011, was not returned to the manufacturer for evaluation.Neither the reporting physician nor the reporting consumer provided an assessment of relatedness between the events and the treatment with human insulin or insulin lispro; however the causality of the hospitalization was reported as unknown.Neither the reporting physician nor the reporting consumer provided an assessment of relatedness between the events and the humapen luxura.Update 29-aug-2017: this case was considered to be non-valid as there was a hospitalization described only.Edit 05-sep-2017: clarification of information received on 25-aug-2017 from the affiliate.This case was still considered to be non-valid as there was no identifiable event.A new reporter was added, humulin 70/30 was recoded to humulin r and the gender of the patient was updated to male.Update 05-sep-2017: this case was initially determined to be non-valid (hospitalization described only).Additional information was received on 30-aug-2017 confirming the reason of the hospitalization.This case was upgraded due to the serious event of blood glucose increased that led to hospitalization.Added the serious events of blood glucose increased and pruritus, a non-serious event of blood glucose increased, insulin lispro (humalog) as a co-suspect drug and laboratory data.Updated the humapen luxura device as suspect.The narrative was added including the new information.Update 25sep2017: additional information received on 25sep2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch/european and canadian (eu/ca) device information, and device return status to not returned to manufacturer.Added date of manufacturer for the pc 4104652 associated with lot 1107b05 humapen luxura (burgundy) device.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA BURGENDY
• 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: 6905112
• MDR Text Key: 87881897
• Report Number: 1819470-2017-00173
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9662
• Device Lot Number: 1107B05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2011
• 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): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 70