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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9662
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 06/30/2020
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
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned an (b)(6) (at the time of initial report) asian female patient of han nationality. Medical history was reported as none. Concomitant medications included unspecified medications for unknown indications. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix 25, cartridge), via a reusable humapen luxura burgundy device (started approximately sometime in 2010), at morning 10, noon 10, night 10; three times a day, subcutaneously, for diabetes mellitus, beginning approximately sometime in 2013. On an unknown date while on insulin lispro 75/25 treatment, her blood glucose value was up to 24. 8 (units and normal reference range not provided) and due to which she was hospitalized on (b)(6) 2020. Humapen luxura burgundy device was used for about 10 years which was considered as an improper use. Sometime in 2019, injection button of the humapen luxura burgundy device was difficult to press (lot number: 1010b04 and pc number: (b)(4)). Information regarding any corrective treatment, discharge details and outcome for event was not provided. Insulin lispro 75/25 treatment was continued. Follow up would not be possible because the consent to contact the patient and healthcare professional (hcp) was not gained. The operator of the humapen luxura, burgundy device and his/her training status was not provided. The humapen luxura, burgundy general model duration of use was not provided and the suspect humapen luxura, burgundy device model duration of use was approximately 10 years. The suspect humapen luxura, burgundy device was continued and its return was not expected. The reporting consumer did not if the event was related with insulin lispro protamine suspension 75%/insulin lispro 25% treatment and did not provide its relatedness with humapen luxura, burgundy device. Update 02-jul-2020: information was received from regional complaint person (rcp) on (b)(6) 2020. No new medical significant information was received. No change was made to case. Edit 09-jul-2020: upon review of information received on 28-jun-2020, product complaint for humapen luxura, burgundy device was added in narrative and pc was reprocessed. No other changes were done. Edit 09jul2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN 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 Key10252416
MDR Text Key205333056
Report Number1819470-2020-00080
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 consumer,foreign
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9662
Device Lot Number1010B04
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2010
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: 07/09/2020 Patient Sequence Number: 1
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