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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 Device Inoperable (1663); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Reportable malfunction/incident identified. Investigation in progress. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
(b)(4). This device case, which does not involve an adverse event, reported by a consumer, who contacted the company with a product complaint, concerns a patient of unknown age, gender, or origin. The patient was taking an unspecified medication for treatment of an unknown indication. On (b)(6) 2016, the humapen luxura with burgundy pen body was reported to no longer functionable. This humapen luxura was associated with (b)(4), lot 1112b01. The device was returned on 22mar2016, and upon investigation found a greater than one number misalignment. The operator of the device, training status, and length of use were unknown. The device was returned on 22mar2016. The humapen luxura was not continued.
 
Manufacturer Narrative
No further follow up is planned. Evaluation summary: a patient reported their humapen luxura device was not functional. The device was not associated with an adverse event. Investigation of the returned device (batch 1112b01, manufactured december 2011) found a misalignment of the barrel, damage to the dialing screw threads and the device would dial past the 60 unit mark. The damage was consistent with excessive torque being applied by the user and allowed the device to be dialed beyond the maximum dose setting of 60 units. Additional evidence of the excessive torque was observed by the wear and damage to the dialing screw threads. Malfunction confirmed. The investigation determined that the damage was not associated with the assembly of the device. There is evidence of improper use. The user applied excessive force to the dial which caused the damage and misalignment of the device.
 
Event Description
Lilly case id: (b)(6). This device case, which does not involve an adverse event, reported by a consumer, who contacted the company with a product complaint, concerns a patient of unknown age, gender, or origin. The patient was taking an unspecified medication for treatment of an unknown indication. On (b)(6) 2016, the humapen luxura with burgundy pen body was reported to no longer functionable. This humapen luxura was associated with product complaint 3606373, lot 1112b01. The device was returned on 22mar2016, and upon investigation found a greater than one number misalignment. The operator of the device, training status, and length of use were unknown. The device was returned on 22mar2016. The humapen luxura was not continued. Update 18apr2016. Additional information received 18apr2016 from the product complaint safety database did not contain any new information. Edit 18apr2016. Removed medically significance for follow up dated 18apr2016. Update 12may2016: additional information received on 11may2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; updated the improper use and storage to yes; updated the medwatch and european and (b)(6) 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 Key5562884
MDR Text Key43032261
Report Number1819470-2016-00089
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 03/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9662
Device Lot Number1112B01
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/22/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/31/2011
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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