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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 Problems Crack (1135); Device Operates Differently Than Expected (2913)
Patient Problems High Blood Pressure/ Hypertension (1908); Visual Impairment (2138); No Code Available (3191)
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 1819470-2016-00319, since there is more than one device implicated.
 
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 adverse events and a product complaint (pc), with additional information from the initial reporter, concerned a (b)(6) asian male patient. Medical history included unspecified diabetic syndromes, fundus congestion, high blood pressure and diabetic nephropathy. Concomitant medications included unspecified hypotensive medications, also acarbose and metformin for unknown indications. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injection (humulin 70/30) via reusable pen (humapen luxura burgundy), 16 units each morning and 16 units each evening daily, subcutaneously for the treatment of diabetes mellitus beginning on 2004. Since 2004, after taking human insulin isophane suspension 70%/ human insulin 30% treatment, his blood glucose needed to be adjusted (values, units or reference ranges were not provided) once every year and required to be hospitalized. Information regarding hospitalization details, such as laboratory tests during hospitalization and admission or discharge dates, was not provided. On an unspecified date, he complained that the cap of the humapen luxura burgundy was cracked, and the device did not work as well as it used to work (product complaint (b)(4)/ lot 0601b03). He was provided a humapen unknown body type device in 2012, but the humapen luxura burgundy also remained in use. On another unspecified date, he complained that the cap of the humapen unknown body type was cracked, and the device did not work as well as it used to work (product complaint (b)(4)/ lot unknown). In addition, while on treatment, preexisting conditions of fundus congestion, high blood pressure and diabetic nephropathy aggravated gradually (no further details were provided). Fundus congestion and high blood pressure aggravations were considered serious due to their medical significance. On an unknown date he developed visual impairment associated with diabetic eye disease and hypertension. Information regarding outcome of diabetic eye disease event was not provided. He had not recovered from the remaining events. Information regarding corrective treatments was not provided. Human insulin isophane suspension 70%/ human insulin 30% treatment was continued. The operator of the humapens and his or her training status was not provided. The humapen luxura duration of use was approximately 12 years, and the unknown humapen model duration of use was of approximately four years. The humapen luxura burgundy was returned on 23nov2016. The unknown humapen remained in use. The reporting consumer did not provide an assessment of relatedness between the event of diabetic eye disease and human insulin isophane suspension 70%/ human insulin 30; also did not know if the remaining events were related to human insulin isophane suspension 70%/ human insulin 30% treatment and did not provide an assessment of relatedness neither for humapen luxura nor for the unspecified humapen device. Update 28nov2016: additional information from the initial consumer reporter from the original report date of 18nov2016 (provided by the global product complaint safety database) updated the humapen luxura to a humapen luxura burgundy; added the product complaint information and complaint numbers; added the return date of the humapen luxura burgundy; updated the medwatch and european and canadian required device reporting elements; updated the improper use and storage for the humapen luxura burgundy to yes; and updated the narrative. Update 07-dec-2016: additional information received from the initial reporter on 05-dec-2016 in response of a medical questionnaire. Added hypotensive medications as concomitant medications. Added diabetic eye disease as non-serious event. Updated narrative with new information.
 
Manufacturer Narrative
No further follow up is planned. This report is associated with 1819470-2016-00319, since there is more than one device implicated. Evaluation summary: a male patient reported that his humapen luxura device did not work well as it had been used for a long time. The patient experienced abnormal blood glucose levels. The investigation of the returned device (batch 0601b03, manufactured january 2006) found the device met functional requirements and met dose accuracy and glide (injection) force specifications. No malfunction was identified. The patient reported using the device for "approximately 12 years" (although the device was manufactured in 2006). This is beyond its approved use life. The 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 used the device beyond its approved use life. This may not be relevant to the abnormal blood glucose levels since the device met dose accuracy specifications.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complaint (pc), with additional information from the initial reporter, concerned a (b)(6) asian male patient. Medical history included unspecified diabetic syndromes, fundus congestion, high blood pressure and diabetic nephropathy. Concomitant medications included unspecified hypotensive medications, also acarbose and metformin for unknown indications. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injection (humulin 70/30) via reusable pen (humapen luxura burgundy), 16 units each morning and 16 units each evening daily, subcutaneously for the treatment of diabetes mellitus beginning on 2004. Since 2004, after taking human insulin isophane suspension 70%/ human insulin 30% treatment, his blood glucose needed to be adjusted (values, units or reference ranges were not provided) once every year and required to be hospitalized. Information regarding hospitalization details, such as laboratory tests during hospitalization and admission or discharge dates, was not provided. On an unspecified date, he complained that the cap of the humapen luxura burgundy was cracked, and the device did not work as well as it used to work (product complaint (b)(4)/ lot 0601b03). He was provided a humapen unknown body type device in 2012, but the humapen luxura burgundy also remained in use. On another unspecified date, he complained that the cap of the humapen unknown body type was cracked, and the device did not work as well as it used to work (product complaint (b)(4)/ lot unknown). In addition, while on treatment, preexisting conditions of fundus congestion, high blood pressure and diabetic nephropathy aggravated gradually (no further details were provided). Fundus congestion and high blood pressure aggravations were considered serious due to their medical significance. On an unknown date he developed visual impairment associated with diabetic eye disease and hypertension. Information regarding outcome of diabetic eye disease event was not provided. He had not recovered from the remaining events. Information regarding corrective treatments was not provided. Human insulin isophane suspension 70%/ human insulin 30% treatment was continued. The operator of the humapens and his or her training status was not provided. The humapen luxura duration of use was approximately 12 years, and the unknown humapen model duration of use was of approximately four years. The humapen luxura burgundy was returned on 23nov2016. The unknown humapen remained in use. The reporting consumer did not provide an assessment of relatedness between the event of diabetic eye disease and human insulin isophane suspension 70%/ human insulin 30; also did not know if the remaining events were related to human insulin isophane suspension 70%/ human insulin 30% treatment and did not provide an assessment of relatedness neither for humapen luxura nor for the unspecified humapen device. Update 28nov2016: additional information from the initial consumer reporter from the original report date of 18nov2016 (provided by the global product complaint safety database) updated the humapen luxura to a humapen luxura burgundy; added the product complaint information and complaint numbers; added the return date of the humapen luxura burgundy; updated the medwatch and european and canadian required device reporting elements; updated the improper use and storage for the humapen luxura burgundy to yes; and updated the narrative. Update 07-dec-2016: additional information received from the initial reporter on 05-dec-2016 in response of a medical questionnaire. Added hypotensive medications as concomitant medications. Added diabetic eye disease as non-serious event. Updated narrative with new information. Update 15dec2016: additional information received on 14dec2016 from the global product complaint database; for complaint (b)(4) added the device specific safety summary and manufactured date of the device, updated the malfunction field to no; for complaint (b)(4) added the device specific safety summary, added the device was not returned; for both devices updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update19-dec-2016: permission to conduct follow-up was denied from the initial reporter on 14-dec-2016. No new adverse event or product information was received.
 
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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 Key6157904
MDR Text Key61886898
Report Number1819470-2016-00318
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 12/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9662
Device Lot Number0601B03
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/23/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2006
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: 12/09/2016 Patient Sequence Number: 1
Treatment
GUCOBAY; HUMULIN; METFORMIN
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