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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. ABBOTT FREESTYLE LIBRE CGM SENSOR GLUCOSE SENSOR

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ABBOTT DIABETES CARE, INC. ABBOTT FREESTYLE LIBRE CGM SENSOR GLUCOSE SENSOR Back to Search Results
Device Problems Device Slipped (1584); Defective Component (2292)
Patient Problem No Information (3190)
Event Date 06/23/2018
Event Type  malfunction  
Event Description
This issue involves abbott freestyle libre sensor. The sensors cost (b)(6) for a thirty day supply. My third sensor was defective and did not remain adhered to my skin. It came off on a saturday. The customer service line is only open monday-friday, which is inadequate for necessary health care products. Monday i telephoned again, after leaving three messages. Spoke to agent in (b)(6), offered a voucher which could be used at one of 5 pharmacies to replace sensor. But voucher requires a prescription from my doctor. I asked to have sensor shipped overnight. Was told they can ship over 5-7 days. I argued and repeated overnight shipping. I was told they would do this and i would receive them on tuesday, the next day. Today i called for tracking number and was told it takes them a day and a half to arrange shipment, then another day for shipment. This is absurd considering the over (b)(6) cost for this individual device that lasts only ten days, for continuous blood glucose monitoring. I request that the fda work with abbott to promote 24/7 customer service, and guarantee overnight delivery on vitally needed medical products.
 
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Brand NameABBOTT FREESTYLE LIBRE CGM SENSOR
Type of DeviceGLUCOSE SENSOR
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key7645735
MDR Text Key112749368
Report NumberMW5078134
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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