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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); Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338); Mechanical Jam (2983); Output Problem (3005)
Patient Problems Hypoglycemia (1912); Syncope/Fainting (4411)
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, concerned a (b)(6) female (at the time of the report) patient of unspecified origin. Medical history included born prematurely, four autoimmune diseases, celiac disease, hashimoto disease, numerous unspecified allergies and type 1 diabetes. Historical drugs included insulin glargine and insulin degludec. Concomitant medications included chromium, levocarnitine and pyridoxine hydrochloride for unknown indication. The patient received insulin lispro (rdna origin) (humalog 100 u/ml) from a cartridge via a reusable pen (humapen luxura hd), for the treatment of type 1 diabetes mellitus. She also took insulin glargine (rdna origin) (basaglar 100 u/ml) from a cartridge, for the treatment of type 1 diabetes mellitus. Dose regimen and the start dates were not provided. Since an unknown date, she developed damage in her thyroid gland and she was hospitalized many times due to this on an unknown dates. It was reported that the first hospitalization was in 2014. After the thyroid crises (damage), she fought overweight; she had gained 20 kilograms in three weeks. The event of gained weight was considered as serious by the company due to medically significant reasons. By (b)(6) 2021, she had a humapen luxura hd pen that was five years old, and since an unknown date it had not been working properly, it jammed and sometimes did not give insulin ((b)(4); lot 1401g10). Her insulin doses were very important to her, and she was dosing every half unit because she required a half of unit for her evening and night doses. It was not fun for her neither eating in the morning nor having her blood glucose levels at about 30 mg/dl (as reported). The event of hypoglycemia was considered as serious by the company due to medically significant reasons. It was very difficult for her to control her blood glucose levels, because in the morning one unit of insulin lowered them by 20 mg / dl, and in the evening one unit lowered them by as much as 100 mg / dl. Furthermore at 140 mg / dl, she would not fall asleep, but with hypoglycemia, she would wake up from her sleep. Information regarding a corrective treatment and the outcome of the events was not provided. Insulin lispro and insulin glargine treatment status was not provided. The patient was the operator of the humapen luxura hd and her training status was not provided. The humapen luxura hd pen model duration of use was five years (improper use). The reported suspect humapen luxura hd duration of use was five years. The humapen luxura hd was being retained for a possible return. The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro or insulin glargine treatment and suspect device. Edit 01-apr-2021: upon review of the initial information received on 24-mar-2021, updated coding of suspect humapen luxura hd to match model for lot number, and the formulation of insulin glargine to cartridge; in addition information regarding improper use of humapen luxura hd was noted. Also, updated eu/(b)(6) fields indicating that device did not represent a threat of public health and the information about in which countries the device is distributed. Added details regarding the event of hypoglycemia and the impact of insulin doses in her blood glucose levels. Updated narrative accordingly. Edit 05apr2021: updated medwatch and european and (b)(6) (eu/(b)(6)) 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 Key11615867
MDR Text Key260759485
Report Number1819470-2021-00050
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,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9673A
Device Catalogue NumberMS9673
Device Lot Number1401G10
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/15/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/31/2014
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: 04/05/2021 Patient Sequence Number: 1
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