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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HP LUXURA, BURGUNDY FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HP LUXURA, BURGUNDY FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9662
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); Hypoglycemia (1912); Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Swelling (2091); Visual Impairment (2138); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
Since the device is not being returned, evaluation for a malfunction is not possible. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
Lilly case id: (b)(4). This report is associated with product compliant: (b)(4). This solicited case, reported by a consumer via patient support program (psp), with additional information from the initial reporter, concerned a (b)(6) male patient of unknown origin. Medical history included heart was not good. Concomitant medications included insulin glargine for diabetes mellitus. The patient received insulin lispro (rdna origin) injections (humalog, specific type was unknown, also reported as you) cartridge via a pre-filled humapen luxura pen (burgundy), for the treatment of type i diabetes, beginning about 2014. Dose and frequency were not provided. On an unknown date, she put the pen in the refrigerator. Since an unknown date, he went to the outpatient service to measure his blood glucose, and the value was 19 or 20 (no units or reference ranges provided), then, as the control of blood sugar was poor, he would be hospitalized once every year for regulating the blood glucose. When he was in hospital (no dates provided) his hands were swollen and his fingers were black because he had to measure the blood glucose eight times a day. Seemingly in 2016, after two years of insulin lispro treatment, he experienced nerve pathological changes, due to which she started to be hospitalized in department of neurology in beijing hospital; peripheral neuropathy of both legs was found out. During hospitalization, he was found out cataract, and he had undergone cataract surgery. During 2016, he was hospitalized for cataract surgery. He was discharged from hospital on an unknown date. About two months later (no dates provided) his blood glucose was high, up to 23 (no units provided); so he was hospitalized again for infusion. Hospitalization details were not provided. Since an unknown date, both legs could not walk; this event was considered serious due to its medical significance. Since an unknown, he could not see clearly. Around (b)(6) 2019, his eyes could not see clearly and he could not see; therefore he was hospitalized again around (b)(6) 2019; specific admission and discharge dates, corrective treatment or further details were not provided. By (b)(6) 2019 he was not in hospital. On unknown dates, he had been hospitalized in endocrinology, cardiology, neurology, surgery and ophthalmology departments (no reasons provided), during hospitalizations in other departments (besides of endocrinology) his blood glucose could not be controlled (no values provided) according to the dosage of insulin injected in the endocrinology department and his dose had not been adjusted. No information regarding corrective treatment, outcome of the events and insulin lispro treatment status was provided. The patient was the operator of the humapen luxura burgundy and her training status was not provided. The humapen luxura model and suspect humapen luxura burgundy durations of use were not reported. Suspect humapen was replaced on an unknown date and its return was not expected. The reporting consumer did not provided the relatedness assessment between the events and insulin lispro treatment. The case was cross-linked with case (b)(4) for having same patient. Update 03-jul-2019: additional information was received from the initial reporter via psp on (b)(6) 2019. This case was upgraded due to the addition of two serious events of blood glucose increased. Added the serious event of visual impairment requiring hospitalization; and the serious event of unable to walk. Updated description of the serious event neurological changes to peripheral neuropathy; and added seriousness criteria for the cataract event (hospitalization required). Added the non-serious events of hand swelling, bruising and blood glucose abnormal. Added medical history and lab data. Added partial start date of therapy. Updated device from concomitant to suspect. Updated narrative accordingly. Edit 05-jul-2019: upon internal review, as determined causality was changed for the event of peripheral swelling from yes to no. No other changes were performed in the case. Edit 08jul2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting. No new information added. Edit 09-jul-2019: upon review of information received on (b)(6) 2019, amended patient gender (from she to he) in the following sentences, he put the pen in the refrigerator and he started to be hospitalized.
 
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Brand NameHP LUXURA, BURGUNDY
Type of DeviceFOR 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
chris davis
lilly corporate center
indianapolis, IN 46285
3174334585
MDR Report Key8781997
MDR Text Key150854625
Report Number1819470-2019-00124
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K142518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9662
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
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 Treatment Data
Date Received: 07/11/2019 Patient Sequence Number: 1
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