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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 Device Operates Differently Than Expected (2913)
Patient Problems Eye Injury (1845); Hyperglycemia (1905); Dizziness (2194); Hematuria (2558)
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 1819470-2016-00340 and 1819470-2016-00342, since there is more than one device implicated.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a 64 year old asian female patient. Medical history included coronary heart disease, hypertension and family history of diabetes. Concomitant medications were not reported. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30 100 iu/ml) 10-12 unspecified units in the morning and 8-10 unspecified units at night, via cartridge via reusable pen (humapen ergo) subcutaneously for the treatment of diabetes mellitus. Start date was not reported. In 2011, the humapen ergo could not be pushed down ((b)(4)/lot unknown), and was replaced by a humapen luxura burgundy device with lot 0711b06 in 2011. On an unspecified date (also reported as conflicting date (b)(6) 2016), her blood glucose was not controlled well and she was hospitalized to adjust blood glucose (it was unclear which device was in use at the time of the increased blood glucose). She was then changed to insulin lispro (humalog 100 iu/ml) via cartridge via reusable pen (humapen ergo) for the treatment of diabetes mellitus. Dosage regimen and start date were not provided. After several months she switched back to human insulin isophane suspension 70%/ human insulin 30% due to economic issues. Since 2012, she experienced phenomena of eyes not good. In 2014, the injection force was high on the humapen luxura burgundy ((b)(4)/ lot 0711b06). There was no foreign material in the device; the injection button was pushed slowly, the needle was not clogged or bent; and the needle size was as prescribed. She was checked out (as reported) early stage cataract in 2015. In 2016, she experienced dizziness and in (b)(6) 2016 she fainted on the street because blood glucose control was not ideal. She was diagnosed with pancreas islet function not good after being sent to hospital. She was hospitalized for 10 days (unspecified dates). After this, her insulin dosage was increased to 22-26 unspecified units in the morning and 18-22 unspecified units at night. In (b)(6) 2016, the injection force was high on the humapen luxura burgundy ((b)(4)/ lot 1112b01). There was no foreign material in the device; the injection button was pushed slowly, the needle was not clogged or bent; and the needle size was as prescribed. In (b)(6) 2016, she was hospitalized due to acute cystitis. At that time she also experienced hematuria and dizziness. Information regarding corrective treatment was not provided. Outcome for the events of dizziness and condition of blood glucose was recovering. Outcome for the remaining events was not provided. Human insulin isophane suspension 70%/ human insulin 30% treatment was ongoing. The user of the humapens and their training status was not provided. The humapen ergo duration of use started on an unspecified date until 2011; the second device (humapen luxura burgundy lot 0711b06) was started in 2011 as a replacement for the humapen ergo; and the third device (humapen luxura burgundy lot 1112b01) was started on an unspecified date. The two humapen luxura devices were returned on 19dec2016: the status of the humapen ergo was not provided. The reporting consumer related the events to insulin isophane suspension 70%/ human insulin 30% treatment and did not provide an assessment of relatedness between the events and the humapen ergo devices. Update 21dec2016 additional information received on 14dec2016 from the global product complaint database updated the devices with lot numbers 0711b06 and 1112b01 from humapen ergo to humapen luxura burgundy based on verifiable lot numbers; added the (b)(4) with product complaint information; added the return date of the two humapen luxuras; added the medwatch and european and canadian required device reporting elements for regulatory reporting; added the conflicting date for the high blood glucose; and updated the narrative. Update 27-dec-2016: additional information was received from the rcp on 16-dec-2016. Product complaint reference numbers had been previously processed. Upon review, outcomes of the events fainting and pancreas function decreased were corrected (from recovering to unknown). The phrase dosage regimen (regarding human insulin isophane suspension 70%/ human insulin 30%) was removed as it had been reported. No additional changes were done. Update 06-jan-2017: information was received on 04-jan-2017. Follow up could not be attempted since the telephone of the reporter was turned off. No additional clinical information was received.
 
Manufacturer Narrative
No further follow up is planned. This report is associated with 1819470-2016-00340 and 1819470-2016-00342 since there is more than one device implicated. Evaluation summary: a female patient reported that the injection force on her humapen luxura device was high. She experienced abnormal blood glucose levels. The patient experienced increased blood glucose. The investigation of the returned device (batch 0711b06, manufactured november 2007) found the device met functional requirements and met dose accuracy and glide (injection) force specifications. No malfunction was identified. There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(6). This spontaneous case, reported by a consumer who contacted the company to report an adverse event, concerned a (b)(6) asian female patient. Medical history included coronary heart disease, hypertension and family history of diabetes. Concomitant medications were not reported. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30 100 iu/ml) 10-12 unspecified units in the morning and 8-10 unspecified units at night, via cartridge via reusable pen (humapen ergo ii) subcutaneously for the treatment of diabetes mellitus. Start date was not reported. In 2011, the humapen ergo ii could not be pushed down (product complaint 3855376/lot unknown), and was replaced by a humapen luxura burgundy device with lot 0711b06 in 2011. On an unspecified date (also reported as conflicting date (b)(6) 2016), her blood glucose was not controlled well and she was hospitalized to adjust blood glucose (it was unclear which device was in use at the time of the increased blood glucose). She was then changed to insulin lispro (humalog 100 iu/ml) via cartridge via reusable pen (humapen ergo ii) for the treatment of diabetes mellitus. Dosage regimen and start date were not provided. After several months she switched back to human insulin isophane suspension 70%/ human insulin 30% due to economic issues. Since 2012, she experienced phenomena of eyes not good. In 2014, the injection force was high on the humapen luxura burgundy (product complaint 3855377/ lot 0711b06). There was no foreign material in the device; the injection button was pushed slowly, the needle was not clogged or bent; and the needle size was as prescribed. She was checked out (as reported) early stage cataract in 2015. In 2016, she experienced dizziness and in (b)(6) 2016 she fainted on the street because blood glucose control was not ideal. She was diagnosed with pancreas islet function not good after being sent to hospital. She was hospitalized for 10 days (unspecified dates). After this, her insulin dosage was increased to 22-26 unspecified units in the morning and 18-22 unspecified units at night. In (b)(6) 2016, the injection force was high on the humapen luxura burgundy (product complaint 3855378/ lot 1112b01). There was no foreign material in the device; the injection button was pushed slowly, the needle was not clogged or bent; and the needle size was as prescribed. In (b)(6) 2016, she was hospitalized due to acute cystitis. At that time she also experienced hematuria and dizziness. Information regarding corrective treatment was not provided. Outcome for the events of dizziness and condition of blood glucose was recovering. Outcome for the remaining events was not provided. Human insulin isophane suspension 70%/ human insulin 30% treatment was ongoing. The user of the humapens and their training status was not provided. The humapen ergo ii duration of use started on an unspecified date until 2011; the second device (humapen luxura burgundy lot 0711b06) was started in 2011 as a replacement for the humapen ergo ii; and the third device (humapen luxura burgundy lot 1112b01) was started on an unspecified date. The two humapen luxura devices were returned on 19dec2016; and no malfunction was found. The humapen ergo ii was not returned. The reporting consumer related the events to insulin isophane suspension 70%/ human insulin 30% treatment and did not provide an assessment of relatedness between the events and the humapen ergo devices. Update 21dec2016 additional information received on 14dec2016 from the global product complaint database updated the devices with lot numbers 0711b06 and 1112b01 from humapen ergo to humapen luxura burgundy based on verifiable lot numbers; added the product complaint numbers 3855376, 3855377, and 3855378 with product complaint information; added the return date of the two humapen luxuras; added the medwatch and european and canadian required device reporting elements for regulatory reporting; added the conflicting date for the high blood glucose; and updated the narrative. Update 27-dec-2016: additional information was received from the rcp on 16-dec-2016. Product complaint reference numbers had been previously processed. Upon review, outcomes of the events fainting and pancreas function decreased were corrected (from recovering to unknown). The phrase dosage regimen (regarding human insulin isophane suspension 70%/ human insulin 30%) was removed as it had been reported. No additional changes were done. Update 06-jan-2017: information was received on 04-jan-2017. Follow up could not be attempted since the telephone of the reporter was turned off. No additional clinical information was received. Update 13-jan-2017: information was received on 11-jan-2017. Follow up could not be attempted since the telephone of the reporter was turned off. No additional clinical information was received. Update 23-jan-2017: upon review, it was changed the as determined causality into the case from not reported to yes according to the information entered into the narrative. Additional information was received on 19-jan-2017 from the affiliate via psp. This case was considered to be lost to follow up as there was no answer after the third attempt to conduct follow up. No further follow ups will be attempted. Narrative was updated. Update 24jan2017: additional information received on 23jan2017 from the global product complaint database added the device specific safety summary for all three devices; added the manufactured date for the humapen luxuras; updated the malfunction field to no for the humapen luxuras; updated the humapen ergo to a humapen ergo ii based on the affiliates assessment of device; added the humapen ergo ii was not returned; updated the medwatch and european and canadian required device reporting elements for all three devices; 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 Key6228583
MDR Text Key64047158
Report Number1819470-2016-00341
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 01/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9662
Device Lot Number0711B06
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/19/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2007
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: 01/06/2017 Patient Sequence Number: 1
Treatment
HUMALOG; HUMULIN
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