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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
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. This report is associated with 1819470-2020-00065 since there is more than one device implicated.
 
Event Description
Lilly case id: (b)(4). This report is associated with product complaint: (b)(4). This solicited fetal case of a retrospectively reported maternal case, reported by a consumer via a patient support program (psp), concerned a baby patient of unknown age of gestation, gender or origin. The mother was (b)(6) year-old. Her medical history included current pregnancy with advanced age, diabetes mellitus, three previous pregnancies (two abortions and one premature baby) and historical drugs human insulin isophane suspension (rdna origin) injections (humulin n) and human insulin (rdna origin) injections (humulin r) during her third pregnancy. She did not receive any concomitant medication. She did receive during current pregnancy both human insulin (rdna origin) injections (humulin r), 80 international units (iu), three times daily and human insulin isophane suspension (rdna origin) injections (humulin n), 10 iu daily, both via cartridge via reusable pens (humapen luxura burgundy), for the treatment of diabetes mellitus and beginning on (b)(6) 2020; routes of administration were not reported. The last menstrual period and estimated due date were not reported. The fetus was exposed to human insulin and human insulin isophane suspension for approximately two weeks. No prenatal testing results were provided. The mother experienced issues with both humapens luxura: the piston of one failed and the other one was sticked; because of that, she was not able to take the insulins dosage completely (product complaint (b)(4)/lot 1308b02; product complaint (b)(4)/lot 1308b02). On unspecified date, her blood glucose level was increased to 340-350 (no units or reference ranges were provided) and her hba1c level was 10. 8. Then, on (b)(6) 2020, her physician found out that her baby was dead on her womb. As of (b)(6) 2020, no information regarding mode of delivery was reported, but it was known that, on (b)(6) 2020, she would have an operation. No further complications were reported. The operator of the humapens luxura and his or her training status were not provided. The humapen luxura model and suspect humapens luxura duration of use was of four or five years. The action taken with the suspect humapens luxura was not provided and their return was expected. The reporting consumer did not provide an assessment of relatedness between the events, human insulin and human insulin isophane suspension therapies or the humapens luxura; the exposure event was entered for tracking purposes. This fetus case is associated with another fetus case (previous pregnancy, same mother) due to same reporter: (b)(4). Edit 04jun2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting. No new information added. Update 08-jun-2020: information was received on 03-jun-2020 contained product complaint (pc) number. Pc number was processed accordingly and no new information was added to the case.
 
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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
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
medical device manufacturing
415 red cedar street
menomonie, wi
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, in 
4334585
MDR Report Key10128901
MDR Text Key194473586
Report Number1819470-2020-00066
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 company representative,consum
Type of Report Initial,Followup,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9662
Device Lot Number1308B02
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2013
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: 06/08/2020 Patient Sequence Number: 1
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