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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES Back to Search Results
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.
 
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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 Key7183675
MDR Text Key97059085
Report Number1819470-2017-00233
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00300029673019
UDI-Public00300029673019
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063151
Number of Events Reported1
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 NumberMS9673
Device Lot Number1203G02
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 Received01/11/2018
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 Number1
Patient Outcome(s) Other;
Patient Age74 YR
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