Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA, UNKNOWN PEN BODY TYPE; FOR TREATMENT PURPOSES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELI LILLY AND COMPANY HUMAPEN LUXURA, UNKNOWN PEN BODY TYPE; FOR TREATMENT PURPOSES Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Memory Loss/Impairment (1958); Burning Sensation (2146)
Event Date 04/09/2018
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
Lilly case id: (b)(6).This report is associated with product compliant: pending.This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) female patient of unknown origin.Medical history was not reported.Concomitant medications included two unspecified medicines used approximately in 2016.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) through a cartridge, via reusable pen (humapen luxura, brown), subcutaneously as required according to the blood glucose levels, for the treatment of type two diabetes, beginning approximately in 2000.Since an unspecified date she experienced forgetfulness.She had been using her humapen luxura device for approximately 18 years.Since an unknown date, she possibly had mycetes and was using unspecified cream and softener for the same.On an unknown date, she suffered from burning sensation on her feet when her blood glucose level increased.There was no wound on her feet but, she could not step on.Approximately in 2016, she started to use two medicines (name and start date was not provided).On (b)(6) 2018, she tried injecting at noon and her humapen luxura broke down so she was unable to inject her dose and because of that her blood glucose levels increased to 800 (no units).The event was considered serious for medical significance.She did not eat anything and her blood glucose levels decreased.Also her blood glucose level did not have balance it was sometimes decreased (values and reference range not provided) and sometimes increased (values and reference range not provided).As of (b)(6) 2018, there was no wound on her feet but, she could not step on.There was no burning sensation, numbness or prickling on her feet.Sometimes, she suffered from low blood glucose level but, she did not suffer from high blood glucose level.Sometimes, blood glucose levels rose to 160 and 170 at most but it did not increase up to that.She was paying attention to her diet.Outcome of the events blood glucose decreased, blood glucose increased, gait disturbance, forgetfulness, missed dose, device usage issue and mycetes was not reported.She was recovered from burning sensation on her feet and was not recovered from the remaining event.Information regarding any other corrective treatment and insulin lispro treatment status was not reported.The patient was the operator of the humapen luxura and her training status was unknown.The general and suspect device duration of use was of approximately 18 years.The humapen was replaced and it would be evaluated if returned.The reporting consumer did not provide an assessment between the events and insulin lispro or the humapen luxura device.Update 13-apr-2018: additional information received from initial reporter via a psp on (b)(6) 2018.Updated the suspect device from humapen unknown to humapen luxura unknown, updated patient demographic details.Added a new non serious event of blood glucose decrease.Updated narrative with new information.Edit 16apr2018: updated medwatch and (b)(6) fields for expedited device reporting.No new information added.Edit 16apr2018: corrected medwatch and (b)(6) fields for expedited device reporting; results from 3211 to 3233.No new information added.Update 25-apr-2018: additional information received from initial reporter via a psp on (b)(6) 2018.Added four new non serious event of blood glucose increase, gait disturbance, mycetes and burning sensation on her feet.Added new lab tests.Updated narrative with new information.
 
Manufacturer Narrative
New updated and corrected information is referenced within the update statements please refer to statement dated 25jun2018 in the field.No further follow up is planned.Evaluation summary: a female patient reported when using her humapen luxura device "the black rod that gave the insulin went down and the piston pushing piece was broken during the injection." she was unable to inject her insulin dose.She experienced increased blood glucose.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen luxura devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.The patient also reported using the device for 18 years.While this is not possible since the humapen luxura was first available in 2005, it is likely the patient used the device beyond the recommended use period.The core user manual states the humapen luxura device has been designed to be used for up to 6 years after first use.There is evidence of improper use.The patient likely used the device beyond its recommended use life.It is unknown is this misuse is relevant to the event of increased blood glucose.
 
Event Description
Lilly case id: (b)(4).This report is associated with product compliant: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a 66 year-old female patient of unknown origin.Medical history was not reported.Concomitant medications included two unspecified medicines used approximately in 2016.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) through a cartridge, via reusable pen (humapen luxura, unknown color), subcutaneously as required according to the blood glucose levels, for the treatment of type two diabetes, beginning approximately in 2000.Since an unspecified date she experienced forgetfulness.She had been using her humapen luxura device for approximately 18 years.Since an unknown date, she possibly had mycetes and was using unspecified cream and softener for the same.On an unknown date, she suffered from burning sensation on her feet when her blood glucose level increased.There was no wound on her feet but, she could not step on.Approximately in 2016, she started to use two medicines (name and start date was not provided).On (b)(6) 2018, she tried injecting at noon and her humapen luxura broke down so she was unable to inject her dose (product complaint (b)(4)/ lot number unknown) and because of that her blood glucose levels increased to 800 (no units).The event was considered serious for medical significance.She did not eat anything and her blood glucose levels decreased.Also her blood glucose level did not have balance it was sometimes decreased (values and reference range not provided) and sometimes increased (values and reference range not provided).As of (b)(6) 2018, there was no wound on her feet but, she could not step on.There was no burning sensation, numbness or prickling on her feet.Sometimes, she suffered from low blood glucose level but, she did not suffer from high blood glucose level.Sometimes, blood glucose levels rose to 160 and 170 at most but it did not increase up to that.She was paying attention to her diet.Outcome of the events blood glucose decreased, blood glucose increased, gait disturbance, forgetfulness, missed dose, device usage issue and mycetes was not reported.She was recovered from burning sensation on her feet and was not recovered from the remaining event.Information regarding any other corrective treatment and insulin lispro treatment status was not reported.The patient was the operator of the humapen luxura and her training status was unknown.The general and suspect device duration of use was of approximately 18 years.The humapen luxura (unknown color) was not returned to the manufacturer.The reporting consumer did not provide an assessment between the events and insulin lispro or the humapen luxura device.Update 13-apr-2018: additional information received from initial reporter via a psp on 10-apr-2018.Updated the suspect device from humapen unknown to humapen luxura unknown, updated patient demographic details.Added a new non serious event of blood glucose decrease.Updated narrative with new information.Edit 16apr2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Edit 16apr2018: corrected medwatch and european and canadian (eu/ca) fields for expedited device reporting; results from 3211 to 3233.No new information added.Update 25-apr-2018: additional information received from initial reporter via a psp on 20-apr-2018.Added four new non serious event of blood glucose increase, gait disturbance, mycetes and burning sensation on her feet.Added new lab tests.Updated narrative with new information.Update 20-jun-2018: additional information received on 18-jun-2018.Added pc number tr 4393975.No new medically significant information added to the case.Update 25jun2018: additional information received on 25jun2018 from the global product complaint database.Entered device specific safety summary (dsss) and updated the medwatch and european and canadian (eu/ca) device fields and improper use and storage from no to yes for the suspect device associated with (b)(4).Corresponding fields and narrative updated accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUMAPEN LUXURA, UNKNOWN PEN BODY TYPE
Type of Device
FOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
MDR Report Key7487893
MDR Text Key107450924
Report Number1819470-2018-00064
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 07/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age66 YR
Patient Weight86
-
-