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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA, CHAMPAGNE FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA, CHAMPAGNE FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9663
Device Problems Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. A follow-up report will be submitted when the final evaluation is completed as necessary.
 
Event Description
(b)(4). This spontaneous device only case, reported by a consumer who contacted the company to report an adverse events and a product complaint, concerned a (b)(6)-years-old female patient of an unknown origin. Medical history included diabetic since 60 years ago. Concomitant medication included insulin human injection/isophane used for an unknown indication. The patient received insulin human injection/isophane (densulin n) via a reusable pen (humapen luxura champagne), 9 units daily, subcutaneously, for the treatment of unknown indication, beginning an unknown date. On an unknown date she had hypoglycemia and that caused her to become unconscious and also had neuropathy. The events of hypoglycemia and unconscious were considered as serious by company due to their medically significance. Since an unknown date she had a humapen luxura device that did not worked since (b)(6) 2020 (two days ago) because she had to push really hard and it took a lot of work for the insulin to come out (product complaint 5291908/lot number 1206b03). She have to apply nine units at noon, but with the device of insulin human injection/isophane, she only could placed 8 or 10 units, but with the humapen luxura device she could place the 9 units that she needed, that was why she used the humapen luxura device (improper use of the device). Her social work did not give her the unspecified insulin from company anymore, and they gave to her insulin human injection/isophane. Since an unknown date, she used bd ultrafine needles, she only used one needle until she place a new insulin cartridge (improper use of the device). Information regarding corrective treatment, outcome of the events and status of humapen luxura device was not provided. The patient was the operator of the humapen luxura champagne device and her training status was not provided. The general humapen luxura champagne device duration of used and suspect humapen luxura champagne device duration of use was unknown. The action taken with humapen luxura champagne device was unknown and its return was expected. The reporting consumer did not provide relatedness assessment between the events and humapen luxura device. Edit 18-sep-2020: upon review of the information received on 15-sep-2020, product complaint# (b)(4) was processed in the case accordingly. No other changes were made to the case. Edit 18sep2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting and added contact log accordingly. No new information added. Update 21-sep-2020: information was received on 16-sep-2020 contained product complaint (pc) number. Pc number was already processed and no new information was added to the case. Update 23sep2020: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
 
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Brand NameHUMAPEN LUXURA, CHAMPAGNE
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 Key10576606
MDR Text Key208322843
Report Number1819470-2020-00124
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 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9663
Device Lot Number1206B03
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2012
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: 09/23/2020 Patient Sequence Number: 1
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