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

Model Number MS9673

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

New, updated and corrected information is referenced within the update statements in describe event or problem.No further follow-up is planned.Evaluation summary: the reporter stated that he could not see the control number or expiration date because of his (b)(6) and his eyesight that was described as not great.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.The eyesight of the patient was reportedly not that great.The user manual states the humapen luxura half-dose is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it.Failure to follow the instructions may result in the wrong insulin dose being delivered.

Event Description

(b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unknown origin.Medical history was not reported.Concomitant medications included insulin glargine for type 1 diabetes.The patient received insulin lispro (rdna origin) (humalog, 100 u/ml) through a cartridge via reusable pen humapen luxura half-dose (hd) pen with sliding scale, subcutaneously for the treatment of type 1 diabetes mellitus, beginning approximately since 2013.On an unknown date, after starting insulin lispro treatment, he had problem with his insulin lispro in his humapen luxura hd device.On (b)(6) 2017, in the morning he had an extreme high blood sugar (values were not provided).He took 10 units to try to counteract this, but, two to three hours later it still did not work to lower his blood sugar.Then at lunch he took 7 units.His cgm (glucose monitor) was setting off a lot of alarms and indicated he was having an extreme low blood sugar around 40 (units and reference ranges were not provided).He was eating everything he could and drinking everything sugary he could to finally get it from 40 up to 90.He had been using the vial for a few weeks now.It was possible that he overdosed the insulin at lunch time.He had something like this happen before when he has taken the insulin lispro and did not have a reaction (pc for cart; (b)(4), lot number unknown).Then also he said he has taken the insulin and had extreme lows (values were not provided).He had been taking insulin for 40 years so maybe it is his body.He might his skin because he has been doing this for decades.Possibly he had been using this cartridge for longer than 28 days.He said that since he had been using this glucometer that he had not needed as much insulin as before and he has not kept track of it.He could not see the control number or expiration date because he was (b)(6) and his eyesight was not that great.The blood sugar events were considered as serious due to their medical significance.Information regarding corrective treatment and outcome of the events was not reported.Therapy with insulin lispro was continued.The user of the humapen luxura hd pen was the patient and his training status was not provided.The humapen luxura hd pen general duration of use and the suspect humapen luxura hd device durations of use were not reported.The action taken with the suspect humapen luxura hd pen was not provided and was not returned to the manufacturer.The reporting consumer did not relate the events to insulin lispro drug or humapen luxura hd.Update 10jan2018: updated the medwatch /european and canadian (eu/ca) device information and device return status to not returned to manufacturer.Entered device specific safety summary (dsss).Added unique identifier number (udi) for the suspect humapen luxura hd pen of (b)(4).Corresponding fields and narrative updated accordingly.

• 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: 7183675
• MDR Text Key: 97059085
• Report Number: 1819470-2017-00233
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673
• Device Lot Number: 1203G02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 74 YR