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U.S. Department of Health and Human Services


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Model Number MS9675001AMF1
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 11/04/2010
Event Type  malfunction  
Event Description
(b)(6). Dear fda, i am complaining about a humalog insulin delivery pen luxura made by eli lilly and the subsequent, so called, customer service. The pen broke. The pen has a screw device that turns and depresses a plunger below an insulin cartridge vial. The flat top of this screw came/broke off. I called the eli lilly company to ask if it -the flat top- could be placed back and fixed easily. The person at eli lilly to whom i spoke told me it was broken and the screw shaft and flat top were all made from one single piece of metal. My new replacement pen already a wobbly flat top part of the screw device which leads me to think that the screw shaft and flat top are not one metal piece, but are joined together in someway and not very durable. This humalog luxura pen seems to have a flawed design and should be re-evaluated by the fda. Eli lilly has sent me an envelope in which to return the original pen and made several phone calls to my home asking for the broken pen. I am keeping this pen until i am satisfied that my complaint and suggestions to you and to eli lilly have been noted. I would be willing to send the luxura pen to the fda for re-evaluation if necessary. Eli lilly customer service - the customer service person at eli lilly asked several personal health related questions before she would address the issue of the broken pen. If i have product malfunction, e. G. , a car, an appliance or computer i am not asked a variety of personal questions which have no real relationship to the broken part of the product. I am not asked for my unpublished phone number on the pretext that the company may wish to contact me on that line and also if i am assured the broken item will be replaced immediately (by a voucher) at no cost i expect that to be true. I was also asked for the serial number of the pen. I had to look at part of the pen which had very pale gray lettering which was difficult to read when i could have been told the number was easy to see in bold black letters on the original box which i still had. I was then told to ask my doctor to call in a new pen prescription to my local pharmacy and promised that immediately (no longer than 30 minutes) eli lilly would call in a voucher for replacement pen at no cost. My pharmacy never received the voucher from lilly and i had to cover the cost of the replacement pen, which in my case was an essential purchase. Eli lilly has never called or faxed a voucher to the pharmacy. I look forward to your reply. (b)(6).
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Type of DeviceINSULIN PEN
Manufacturer (Section D)
MDR Report Key2025269
MDR Text Key1954587
Report NumberMW5019848
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/07/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2011
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9675001AMF1
Device Lot NumberA344554
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/07/2011 Patient Sequence Number: 1