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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC ABBOTT FREESTYLE LIBRE 10 DAY SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC ABBOTT FREESTYLE LIBRE 10 DAY SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Unable to Obtain Readings (1516); Detachment of Device or Device Component (2907)
Patient Problem Blood Loss (2597)
Event Date 02/11/2019
Event Type  malfunction  
Event Description
Bought an abbott freestyle libre 10 day device + 3 sensors. First time device wouldn¿t read ¿ the first sensor was ¿loose. ¿ contacted manufacturer. Second sensor worked. 3rd sensor did not go on the back of my arm ¿ used as directed. Sensor pack came off and needle caused bleed. Contacted manufacturer. No answers. Returned 2 sensors to the manufacturer. 1st ¿loose sensor¿ and 3rd ¿caused bleeding sensor. ¿.
 
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Brand NameABBOTT FREESTYLE LIBRE 10 DAY
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
MDR Report Key8343488
MDR Text Key137057979
Report NumberMW5084096
Device Sequence Number2
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/12/2019
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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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