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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 MS9673A
Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
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 solicited case, reported by a consumer via patient support program (psp), concerned an (b)(6) years-old male patient of unknown origin. Medical history was not provided. Concomitant medications included insulin glargine for the treatment of unknown indication. The patient received insulin lispro (rdna origin) injections (humalog) from a cartridge via unknown device, with unknown dose and route, three times a day for type 1 diabetes, beginning on (b)(6) 2018. On an unknown date in 2019 (used for 1. 5 years- as reported), he started to receive insulin lispro via a reusable humapen luxura hd (half dose) (unknown color). Since an unknown date, he had pain with needle tips (accu fine). The pharmacist stated that it could be psychological since all types of needle tips were in same size and thickness. Accu fine was used in his first hospitalization which was the time that he was firstly diagnosed (unspecified). They were trying to find best solution for him to manage this situation well. Bd microfine needle was advised on pharmacy and the consumer bought bd microfine. On (b)(6) 2020, he was hospitalized due to blood glucose level elevations. He did not remember how high his blood sugar level was when he was hospitalized. He was discharged from hospital on (b)(6) 2020. The needle tips that used in hospitalization duration caused pain to him. When he thought that the blood glucose measured as high, the blood glucose was actually elevated in that time because of the failure of glucose meter. On (b)(6) 2021, the humapen luxura hd pen was damaged, it was jammed, and they requested a new pen (product compliant# (b)(4), lot# 1709g03). He was especially using accu-fine needle tip and the other types of needle tip caused pain. Information regarding further corrective treatment and outcome of the events was not provided. Status of insulin lispro therapy was unknown. The operator of the reusable humapen luxura hd device and his/her training status was not provided. The general reusable humapen luxura hd device model duration of use was unknown and the suspect device duration of use was 1. 5 years. The action taken with status of suspect reusable humapen luxura hd device was unknown and its return status was not provided. The reporting consumer did not provide relatedness assessment between the events and insulin lispro drug and humapen luxura hd device. Update 13-jan-2021: initial information received on 07-jan-2021 and follow up information received on 11-jan-2021 was processed together. Edit 14jan2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added. Upon review, added suspect device age accordingly. Edit 15jan2021: the unique device identifier ((b)(4)) for the humapen luxura half-dose device was added for expedited device reporting.
 
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Brand NameHUMAPEN LUXURA HALF-DOSE PEN
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 Key11177210
MDR Text Key232802628
Report Number1819470-2021-00006
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K100988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Device Lot Number1709G03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2017
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: 01/15/2021 Patient Sequence Number: 1
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