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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA CHAMPAGNE FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9663
Device Problem Failure to Align (2522)
Patient Problems Stroke/CVA (1770); Neuropathy (1983)
Event Type  malfunction  
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 spontaneous case, reported by a consumer, who contacted the company to report a product complaint with adverse event, concerns an adult caucasian female patient, (b)(6). The medical history included a cerebrovascular accident (cva) in 2006. Concomitant medications: insulin glargine for unknown indication. The patient received human insulin nph (rdna origin) (humulin n) cartridge, 16 iu at night, subcutaneously, for type ii diabetes with complications and glucose control and beginning in (b)(6) 2012. Human insulin nph was delivered via humapen luxura (champagne). In 2014, approximately two years after started human insulin nph treatment, the patient was diagnosed with neuropathy. The corrective treatment and laboratorial exams were not provided and the outcome for neuropathy was not recovered. In (b)(6) 2015, the patient experienced a cerebrovascular accident (cva) with loss of the movement of the left arm and was hospitalized for one week. In the hospital, the patient received an unspecified treatment, the laboratorial exams were not provided and she recovered from cva in (b)(6) 2015. On an unspecified date, after started human insulin nph via humapen luxura champagne (lot 1202b01/(b)(4)), the pen was deregulated, reported as the injection button was not going to the end when pressed and the pen was misaligned with the number zero. In addition, it was reported the patient used the reported device since (b)(6) 2012 and stored the pen on refrigerator. The status of human insulin nph treatment was ongoing. The consumer reporter did not provide any relatedness opinion. The patient was the user of the device. Training status was not provided. General and suspect device duration of use was not provided. The return of the pen was expected. Update 22jan2016: additional information received on 19jan2016 from the global product complaint database updated the device to a humapen luxura (champagne); updated the malfunction field to yes/cirm which updated the device to suspect; added non serious no adverse event to associated to the device; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
Manufacturer Narrative
New, updated and corrected information is referenced within the update statements. Please refer to update statement dated 29feb2016. No further follow up is planned. Evaluation summary a female patient reported that the injection button of her humapen luxura was not going to the end when pressed and the pen was misaligned with the number zero. The device was not associated with an adverse event. The device was not returned to the manufacturer for investigation (batch (b)(4), manufactured february 2012). The narrative may suggest the presence of a known malfunction (barrel misalignment). Since the device was not returned, the malfunction could not be confirmed. Malfunction unknown. A complaint history review of this batch did not identify any atypical trends with regard to barrel misalignment. All humapen luxura devices are assessed for dose number alignment during and at the end of the manufacturing process, which also ensures barrel alignment. There is no evidence of improper use or storage.
 
Event Description
(b)(4) this spontaneous case, reported by a consumer, who contacted the company to report a product complaint with adverse event, concerns an adult caucasian female patient, (b)(6). The medical history included a cerebrovascular accident (cva) in 2006. Concomitant medications: insulin glargine for unknown indication. The patient received human insulin nph (rdna origin) (humulin n) cartridge, 16 iu at night, subcutaneously, for type ii diabetes with complications and glucose control and beginning in (b)(6) 2012. Human insulin nph was delivered via humapen luxura (champagne). In 2014, approximately two years after started human insulin nph treatment, the patient was diagnosed with neuropathy. The corrective treatment and laboratorial exams were not provided and the outcome for neuropathy was not recovered. In (b)(6) 2015, the patient experienced a cerebrovascular accident (cva) with loss of the movement of the left arm and was hospitalized for one week. In the hospital, the patient received an unspecified treatment, the laboratorial exams were not provided and she recovered from cva in (b)(6) 2015. On an unspecified date, after started human insulin nph via humapen luxura champagne (lot 1202b01/(b)(4)), the pen was deregulated, reported as the injection button was not going to the end when pressed and the pen was misaligned with the number zero. In addition, it was reported the patient used the reported device since (b)(6) 2012 and stored the pen on refrigerator. The status of human insulin nph treatment was ongoing. The patient was the user of the device. Training status was not provided. General and suspect device duration of use was not provided. The device was not returned. The consumer reporter did not provide any relatedness opinion. Update 22jan2016: additional information received on 19jan2016 from the global product complaint database updated the device to a humapen luxura (champagne); updated the malfunction field to yes/cirm which updated the device to suspect; added non serious no adverse event to associated to the device; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update 29feb2016: additional information received on 29feb2016 from the global product complaint database added the device specific safety summary and manufactured date; added the device is not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
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Brand NameHUMAPEN LUXURA CHAMPAGNE
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 Key5409624
MDR Text Key38248246
Report Number1819470-2016-00015
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 01/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9663
Device Lot Number1202B01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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