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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 Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Mechanics Altered (2984)
Patient Problem Hypoglycemia (1912)
Event Date 03/19/2021
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 an adverse event and product complaint (pc), concerned a (b)(6) female patient with unknown origin. Medical history included being type 1 diabetic. Concomitant medication included other manufacturer insulin glargine for the treatment of type 1 diabetes. The patient received insulin lispro (rdna origin) injections (humalog, 100u/ml), from cartridge via a reusable device humapen luxura hd, at unknown dose, on a 1:9 ratio with her carbohydrate ratio along with other manufacturer insulin glargine on a 1:8 ratio, subcutaneously, for the treatment of type 1 diabetes, beginning on an unknown date. She was using insulin lispro via a humapen luxura hd since 2016 which was improper use since the period of intended use for the humapen luxura hd was three years. Approximately on (b)(6) 2021 (first time), she had serious low of blood sugar and she took glucagon as corrective treatment. Since an unknown date, humapen luxura hd was not functioning properly. On an unknown date, she possibly did not get the correct dose because of the spinning mechanism (lot number: unknown, pc number: (b)(4)). On an unknown date, she was being tested for coeliac disease but the results were not available. Reportedly, through a lot of work her lows was prevented but she was not sleeping. She would go low in the middle of the night for no reason and then would have to wake up take carbs. She was taking insulin 10 minutes ahead of carbs but now she was taking insulin right when she was eating and it had helped but not solved it. The event of low sugar was reported as serious by the reporter. Outcome of the event multiple lows was not resolved. Information regarding corrective treatment of remaining event, outcome of remaining event and status of insulin lispro treatment was not provided. The patient was the operator of humapen luxura hd and her training status was not provided. The general humapen luxura hd duration was not provided and suspect humapen luxura hd duration was approximately five years as it was started in 2016. The status of humapen luxura hd and information regarding its return was unknown. The initial reporting consumer did not know if the event was related to insulin lispro treatment or humapen luxura hd. The initial reporting consumer did not provide relatedness of remaining event with insulin lispro treatment and related it with the product complaint/issue associated with humapen luxura hd. Edit 13may2021: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added. Edit 20may2021: added unique identifier (udi) (b)(4); 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 Key11855338
MDR Text Key266370971
Report Number1819470-2021-00071
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
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: 05/20/2021 Patient Sequence Number: 1
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