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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 Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Patient Problem Hypoglycemia (1912)
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 device only case, reported by a consumer who contacted the company to report an adverse event and a product complaint (pc), concerned a male patient of an unknown age and origin. Medical history was not provided. Concomitant medication included insulin glargine and insulin human both for unknown indication. The patient received insulin human (gansulin insulin-other manufacturer insulin) via a reusable pen humapen luxura burgundy (purplish red metal) (improper use of the device), for the treatment of unknown indication, beginning on an unknown date. Dosage regimen and, route of administration were not provided. He was using insulin human (gansulin insulin-other manufacturer insulin) via humapen luxura burgundy device (improper use of the device). On an unknown date, the injection button of the humapen luxura burgundy could be pressed after installing the insulin cartridge, but the injection screw could not pop out (product complaint (b)(4), lot 1111b05). When he used the humapen luxura burgundy pen with insulin human, he experienced hypoglycemia all the time after injecting, which required hospitalized to regulate the blood glucose. After he was hospitalized, insulin human was changed to insulin lispro with humapen ergo ii (blue plastic). Information regarding corrective treatment and outcome of the event was not provided. The patient was the user of the humapen luxura burgundy device and his training status was not provided. The general humapen luxura burgundy device model duration and suspect humapen luxura burgundy was not provided. The action taken with humapen luxura burgundy device was unknown and its return status was not provided. The reporting consumer did not provide relatedness assessment between the event and humapen luxura burgundy device. Edit 29jun2021: updated medwatch and european (b)(6) fields for expedited device reporting. No new information added. Edit 14jul021: updated medwatch 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 Key12166663
MDR Text Key268072371
Report Number1819470-2021-00088
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 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9662
Device Lot Number1111B05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2021
Was Device Evaluated by Manufacturer? Yes
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: 07/14/2021 Patient Sequence Number: 1
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