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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 Incorrect Or Inadequate Test Results (2456)
Patient Problems Abdominal Pain (1685); Blurred Vision (2137)
Event Date 12/03/2015
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.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter, concerned a (b)(6) han chinese female patient. Medical history was reported as none. Concomitant medications included an unspecified medication reported as tiaojiang; both for unspecified indication. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge, via a reusable pen (humapen, unknown body type), 30 units in the morning, 8 units at noon and 18 units in the evening, subcutaneously, for the treatment of diabetes mellitus, beginning in 2000. She was also taking acarbose (manufacturer unspecified) with an unspecified dosing regimen, indication for use and start date. In (b)(6)2014, she experienced blurred vision. On (b)(6) 2015, she was hospitalized because her blood glucose was slightly higher; her fasting blood glucose (fbg) levels were 15 and her postprandial blood glucose (ppbg) levels were 26 (units and reference values were not provided). Because of her glucose levels, she took sometimes unspecified oral medications at noon instead of human insulin isophane suspension 70%/human insulin 30%. She also increased her noon dose to 22 units. In addition, on an unspecified date in dec-2015, the patient could not hear clearly. On (b)(6) 2015, she could not inject her human insulin isophane suspension 70%/human insulin 30% dose, because the screw rod of the humapen device had a problem (product (b)(4)/lot 1106801). On the same day, the patient took acarbose tablets and experienced stomach pain. Due to the pain, she could not eat her meal. On (b)(6) 2015, the patient visited her treating physician who suggested continuing on human insulin isophane suspension 70%/human insulin 30%. The action taken with the acarbose was not provided. Information regarding corrective treatment and outcome for the events was not provided. The patient was the operator of the humapen and her training status was not provided. The general humapen use started in 2000. The suspect humapen duration of use was three years. If humapen was returned, evaluation would be performed to determine if a malfunction had occurred. The reporting consumer did not know if the events of blood glucose slightly high, vision blurred, hypoacusis and drug dose omission, were related either with human insulin isophane suspension 70%/human insulin 30% therapy or humapen device. The initial reporter did not provide an opinion of relatedness for the events of stomach pain and could not eat meal. Update 05-jan-2016: upon review, the case was opened to update the medwatch fields for regulatory reporting, and to add the product (b)(4) to the narrative. Update 05-jan-2015: information received on 29-dec-2015 via a psp. No new information was added to the case. Update 08-jan-2016: information received from the initial reporter on 31-dec-2015. Dosage tab was added for acarbose. The non-serious events of stomach pain and could not eat meal were added. Narrative was updated with new information.
 
Manufacturer Narrative
Evaluation summary: a female patient experienced a serious adverse event for increased blood glucose levels on (b)(6) 2015. On (b)(6) 2015, she reported that the injection screw of her humapenluxura device would not move out. The investigation of the returned device (batch (b)(4), manufactured june 2011) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications. No malfunction was identified. Based on the timeline of when the serious increased blood glucose event occurred and the injection screw problem was reported, the complaint does not appear to be related to the serious adverse event. There is no evidence of improper use or storage.
 
Event Description
(b)(4) this solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter, concerned a (b)(6) han chinese female patient. Medical history was reported as none. Concomitant medications included an unspecified medication reported as tiaojiang; both for unspecified indication. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) from a cartridge, via a reusable pen (humapen luxura burgundy), 30 units in the morning, 8 units at noon and 18 units in the evening, subcutaneously, for the treatment of diabetes mellitus, beginning in 2000. She was also taking acarbose (manufacturer unspecified) with an unspecified dosing regimen, indication for use and start date. In (b)(6) 2014, she experienced blurred vision. On (b)(6) 2015, she was hospitalized because her blood glucose was slightly higher; her fasting blood glucose (fbg) levels were 15 and her postprandial blood glucose (ppbg) levels were 26 (units and reference values were not provided). Because of her glucose levels, she took sometimes unspecified oral medications at noon instead of human insulin isophane suspension 70%/human insulin 30%. She also increased her noon dose to 22 units. In addition, on an unspecified date in (b)(6) 2015, the patient could not hear clearly. On (b)(6) 2015, she could not inject her human insulin isophane suspension 70%/human insulin 30% dose, because the screw rod of the humapen luxura device had a problem ((b)(4)/lot 1106b01). On the same day, the patient took acarbose tablets and experienced stomach pain. Due to the pain, she could not eat her meal. On (b)(6) 2015, the patient visited her treating physician who suggested continuing on human insulin isophane suspension 70%/human insulin 30%. The action taken with the acarbose was not provided. Information regarding corrective treatment and outcome for the events was not provided. The patient was the operator of the humapen luxura and her training status was not provided. The general humapen luxura use started in 2000. The suspect humapen luxura duration of use was three years. The device was returned on 18jan2016, no malfunction was found. The reporting consumer did not know if the events of blood glucose slightly high, vision blurred, hypoacusis and drug dose omission, were related either with human insulin isophane suspension 70%/human insulin 30% therapy or humapen luxura device. The initial reporter did not provide an opinion of relatedness for the events of stomach pain and could not eat meal. Update 05-jan-2016: upon review, the case was opened to update the medwatch fields for regulatory reporting, and to add the (b)(4) to the narrative. Update 05-jan-2015: information received on (b)(6) 2015 via a psp. No new information was added to the case. Update 08-jan-2016: information received from the initial reporter on (b)(6) 2015. Dosage tab was added for acarbose. The non-serious events of stomach pain and could not eat meal were added. Narrative was updated with new information. Edit 14-jan-2016: (b)(4) had already processed. No other changes were performed. Update 18-jan-2016: additional information received on 18-jan-2016 from global product complaint database updated the lot number 1106801 to 1106b01 for (b)(4) which updated the device to a humapen luxura burgundy. The return date of the device was added. The european and canadian required device reporting elements were updated. The product tab for humapen luxura and the narrative were updated. Update 17feb2016. Additional information received 17feb2016 from global product complaint database. Entered the previously reported return date on the device tab, entered malfunction as no, added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, updated the medwatch information, entered the manufacture date, and updated the narrative accordingly.
 
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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
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key5366265
MDR Text Key35967631
Report Number1819470-2016-00002
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 company representative,consum
Type of Report Initial,Followup
Report Date 12/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9662
Device Lot Number1106801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2011
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: 01/14/2016 Patient Sequence Number: 1
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