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

Model Number MS9663

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Itching Sensation (1943)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.A follow-up report will be submitted when the final evaluation is completed as necessary.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) asian female patient.Medical history was not reported.Concomitant medications included repaglinide, mecobalamin, calcium carbonate capsules, and sodium bicarbonate, all for unknown indication and an unspecified drug for the treatment of peripheral nerves.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix25) through a cartridge via reusable pen (humapen luxura hd burgundy color, 20 units each morning and 20 units each night twice daily subcutaneously, for the treatment of type ii diabetes, beginning on (b)(6) 2016.On an unknown date, after starting insulin lispro 75/25 treatment, she had been experiencing high blood glucose (no units and values provided) and she was hospitalized on an unknown date.No further information provided.In (b)(6)2017, she started using unspecified oral medication for regulating blood glucose, for which dosage regimen was not provided.In (b)(6) 2017, she after starting unspecified oral medication, she had skin pruritus phenomenon.In (b)(6) 2017, she had been experiencing hands and feet numbness, was inconvenient to walk.In (b)(6) 2018, she started a new humapen luxura, the injection button did not make clicking sound when pushed down ((b)(4), lot-unknown).By (b)(6) 2018, she had been hospitalized five times since (b)(6) 2016 due to blood sugar high (specific dates not provided).No further information provided.Information regarding corrective treatment, discharge details and outcome of events and unspecified oral drug therapy status was not provided.Insulin lispro 75/25 treatment was not reported.The user of the humapen luxura hd and his/ her training status was not provided.The humapen luxura hd general duration of use was not provided.The suspect humapen luxura hd device duration of use were not reported.The action taken with the suspect humapen luxura hd was not provided and return was not expected.The reporting consumer was not sure about any relatedness between events and insulin lispro 75/25 treatment.No assessment was provided for events and humapen luxura hd.The reporting consumer did not provide the relatedness between opinion between events and unspecified oral drug.Edit 10may2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added>.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) asian female patient.Medical history was not reported.Concomitant medications included repaglinide, mecobalamin, calcium carbonate capsules, and sodium bicarbonate, all for unknown indication and an unspecified drug for the treatment of peripheral nerves.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog mix25) through a cartridge via reusable pen (humapen luxura champagne color, 20 units each morning and 20 units each night twice daily subcutaneously, for the treatment of type ii diabetes, beginning on (b)(6) 2016.On an unknown date, after starting insulin lispro 75/25 treatment, she had been experiencing high blood glucose (no units and values provided) and she was hospitalized on an unknown date.No further information provided.In (b)(6) 2017, she started using unspecified oral medication for regulating blood glucose, for which dosage regimen was not provided.In (b)(6) 2017, she after starting unspecified oral medication, she had skin pruritus phenomenon.In (b)(6) 2017, she had been experiencing hands and feet numbness, was inconvenient to walk.In (b)(6) 2018, she started a new humapen luxura, the injection button did not make clicking sound when pushed down (product complaint 4347552, lot number unknown).By (b)(6) 2018, she had been hospitalized five times since (b)(6)2016 due to blood sugar high (specific dates not provided).No further information provided.Information regarding corrective treatment, discharge details and outcome of events and unspecified oral drug therapy status was not provided.Insulin lispro 75/25 treatment was not reported.The user of the humapen luxura and his/ her training status was not provided.The humapen luxura general duration of use was not provided.The suspect humapen luxura device duration of use was not reported.The suspect humapen luxura was not returned to the manufacturer.The reporting consumer was not sure about any relatedness between events and insulin lispro 75/25 treatment.No assessment was provided for events and humapen luxura.The reporting consumer did not provide the relatedness between opinion between events and unspecified oral drug.Edit 10may2018: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 01jun2018: additional information received on 31may2018 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch and european and (b)(6) (eu/(b)(6)) device fields.Corresponding fields and narrative updated accordingly.

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem.Please refer to statement dated (b)(6)2018 in the describe event or problem field.No further follow up is planned.Evaluation summary: a female patient reported that her humapen luxura device injection button did not make a clicking sound when pushed down.The patient experienced increased blood glucose.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.The reported batch number, 1308801, was not a valid batch number; however, it is possible the reporter misread the batch number and the actual batch number is 1308b01, which was marketed in (b)(6).Therefore, a complaint history review was performed on 1308b01 and did not identify any atypical findings with regard to device not accurate or device not working issues.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 or storage.

• Brand Name: HUMAPEN LUXURA CHAMPAGNE
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• MDR Report Key: 7542700
• MDR Text Key: 109232133
• Report Number: 1819470-2018-00085
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9663
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 90