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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 Fluid Leak (1250); Leak/Splash (1354); Insufficient Flow or Under Infusion (2182); Output Problem (3005)
Patient Problem Hyperglycemia (1905)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. 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 complaint: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), concerned a (b)(6) female patient of an unknown ethnicity. Medical history and concomitant medications were not provided. The patient received insulin lispro (rdna origin) injections (humalog 100), from cartridge via a reusable device humapen luxura half-dose (hd), at an unknown dose and frequency subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in (b)(6) 2020. Since an unknown date, while on insulin lispro therapy, humapen luxura hd pen got impaired as it leaked insulin upon adjusting the dose. Due to humapen luxura hd pen impairment, she did not get the full dose. Due to this, her blood glucose level was very high i. E. 500 mg/dl (reference range not provided) due to which she was hospitalized for two days in (b)(6) 2021 (batch number: unknown and pc number: (b)(4)). Information regarding corrective treatment and outcome of the events was unknown. Status of insulin lispro therapy was continued. The operator of humapen luxura hd and his/her training status were not provided. The general humapen luxura hd duration and suspect humapen luxura hd duration was approximately four months as it was started in (b)(6) 2020. Action taken with humapen luxura hd was not provided and its return was expected. The initial reporting consumer did not provide the relatedness assessment of the events with insulin therapy while considered that the events were related to humapen luxura hd. Edit 04may2021: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting. No new information added.
 
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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 Key11784122
MDR Text Key262192156
Report Number1819470-2021-00067
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 consumer,foreign
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2021
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: 05/06/2021 Patient Sequence Number: 1
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