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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Hyperglycemia (1905); Underdose (2542)
Event Date 05/31/2016
Event Type  Injury  
Manufacturer Narrative
This is an initial report. A follow-up report will be submitted when the final evaluation is compeleted.
 
Event Description
(b)(4). This report is associated with product compliant: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) female patient. Medical history included retinopathy (fundus microvascular tumor), nephrotic syndrome, high blood lipids, high blood pressure, peripheral neuropathy, scoliosis (disability), abnormal blood glucose and high blood glucose. Historical medication included human insulin (rdna origin) (humulin 100u/ml) from 2009 to 2014 and insulin lispro (rdna origin) (humalog 100 u/ml) from 2014 to 2015 both for the treatment of diabetes mellitus. Concomitant medications included metformin, glimepiride, glibenclamide, acarbose, insulin glargine and other unspecified medications for an unknown indication. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injection (humalog mix25) through a cartridge via reusable pen (humapen luxura), 20 iu each morning and 16 iu each night, subcutaneously for the treatment of diabetes mellitus beginning in summer 2015, switching from prior human insulin and insulin lispro. On an unspecified date, her blood glucose levels were high and she was hospitalized in (b)(6) 2016. Under her physician suggestion, she stopped insulin lispro protamine suspension 75%/ insulin lispro 25% and restarted insulin lispro 12 iu three times a day. On an unspecified date there was a unknown complaint against the humapen luxura (pc (b)(4) /lot unknown). On an unspecified date, she gave her reusable pen to a family member as a gift and because of that she had not been able to inject her medication for 20 days. Information regarding any corrective treatment, outcome of the events, start and discharge dates and further hospitalization details was not provided. The patient was the operator of the device and her training status was not provided. The device model duration was not provided but started sometime in (b)(6) 2009. The reported device duration of use was not reported. It was unknown if the device was still in use. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy. Update 06sep2016: upon review, this case was opened to update the medwatch and european and canadian required device reporting elements for regulatory reporting. Update 12-sep-2016: additional information received from local affiliate with pc number. Upon internal review humapen unknown type, changes to humapen luxura. Edit 23-sep-2016: upon internal review it was added to the narrative pc number ((b)(4)) and was amended the correct type of humapen (from unknown to luxura). No additional changes were performed.
 
Manufacturer Narrative
New, updated and corrected information is referenced within the update statements in. Please refer to update statement dated 26sep2016. No further follow up is planned. Evaluation summary a female patient reported that the injection button of her humapen luxura device could not be pushed down. The patient experienced increased blood glucose levels. 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 and dose accuracy with high probability. There is no evidence of improper use.
 
Event Description
Lilly case id: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) -year-old female patient. Medical history included retinopathy (fundus microvascular tumor), nephrotic syndrome, high blood lipids, high blood pressure, peripheral neuropathy, scoliosis (disability), abnormal blood glucose and high blood glucose. Historical medication included human insulin (rdna origin) (humulin 100u/ml) from 2009 to 2014 and insulin lispro (rdna origin) (humalog 100 u/ml) from 2014 to 2015 both for the treatment of diabetes mellitus. Concomitant medications included metformin, glimepiride, glibenclamide, acarbose, insulin glargine and other unspecified medications for an unknown indication. The patient received insulin lispro protamine suspension 75%/ insulin lispro 25% (rdna origin) injection (humalog mix25) through a cartridge via reusable pen (humapen luxura), 20 iu each morning and 16 iu each night, subcutaneously for the treatment of diabetes mellitus beginning in summer 2015, switching from prior human insulin and insulin lispro. On an unspecified date, her blood glucose levels were high and she was hospitalized in (b)(6) 2016. Under her physician suggestion, she stopped insulin lispro protamine suspension 75%/ insulin lispro 25% and restarted insulin lispro 12 iu three times a day. On an unspecified date there was a unknown complaint against the humapen luxura (product complaint [pc] 3759729 /lot unknown). On an unspecified date, she gave her reusable pen to a family member as a gift and because of that she had not been able to inject her medication for 20 days. Information regarding any corrective treatment, outcome of the events, start and discharge dates and further hospitalization details was not provided. The patient was the operator of the device and her training status was not provided. The device model duration was not provided but started sometime in (b)(6) 2009. The reported device duration of use was not reported. The device was not returned. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/ insulin lispro 25% therapy. Update 06sep2016: upon review, this case was opened to update the medwatch and (b)(4) required device reporting elements for regulatory reporting. Update 12-sep-2016: additional information received from local affiliate with pc number. Upon internal review humapen unknown type, changes to humapen luxura. Edit 23-sep-2016: upon internal review it was added to the narrative pc number (3759729) and was amended the correct type of humapen (from unknown to luxura). No additional changes were performed. Update 26sep2016: additional information received on 26sep2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and (b)(4) required device reporting elements; and updated the narrative.
 
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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 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
medical device manufacturing
415 red cedar street
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5977780
MDR Text Key55670715
Report Number1819470-2016-00240
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 08/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9662
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2016
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: 09/26/2016 Patient Sequence Number: 1
Treatment
BASALIN; GLIBENCLAMIDE; GLIMEPIRIDE; GLUCOBAY; HUMALOG 25% LISPRO, 75% NPL; METFORMIN
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