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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); No Flow (2991); Unintended Movement (3026); Device Fell (4014); Incomplete or Inadequate Connection (4037)
Patient Problem Diabetic Ketoacidosis (2364)
Event Date 01/31/2021
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 solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) years old pediatric male patient of unknown origin. Medical history and concomitant medication not provided. The patient received insulin lispro (humalog) via cartridge through re-usable humapen luxura half dose 3. 5-5 units thrice daily subcutaneously for treatment of unknown indication beginning in 2013. He started using re-usable humapen luxura half dose in 2017. Approximately on (b)(6) 2021, he got into coma and taken into intensive care. The reason of coma that ketone was found in patients due high blood sugar, he did not receive insulin and because patient did not eat anything when he applied insulin. He stayed in intensive care for three days and one week in normal service of hospital. On an unknown date in (b)(6) 2021, he was discharged. No further information provided. Since on an unknown date, the head of the application humapen luxura hd pen was moving; (product complaint-(b)(4); lot-unknown); it was not stable and might be due to application pen was fallen earlier. Normally the application pen fell many times before, but there was no problem. The problem was in head of the application pen, there was no problem on dosage applying part. There was no cracked or broken part of the application pen after falling; patient received insulin with same application pen. In addition, they dropped and cracked 5-6 application pens before as well and the problem with application pen was about their selves. Information regarding further corrective treatment and outcome of event was not provided. Insulin lispro treatment was continued. The operator of the reusable humapen luxura half dose device was father of the patient and his training status was not provided. The general reusable humapen luxura half dose device model duration of use started in 2017 and suspect reusable humapen luxura half dose device duration of use was not provided. The suspect device was discarded and device return was expected. The reporting consumer did not provide the relatedness between event and insulin lispro treatment and humapen luxura half dose device but considered coma and ketone related to. High blood sugar. Edit (b)(6) 2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added. Update 25-mar-2021: information was received on 22-mar-2021 from the responsible contact person (rcp) provided the product complaint (pc) reference number (b)(4) and pc was processed accordingly. No medically significant information was added. No further changes were done to the case.
 
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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 Key11614570
MDR Text Key260674240
Report Number1819470-2021-00049
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 04/21/2021
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 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 Received04/13/2021
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: 04/05/2021 Patient Sequence Number: 1
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