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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE FREESTYLE LIBRE

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ABBOTT DIABETES CARE FREESTYLE LIBRE Back to Search Results
Model Number FREESTYLE LIBRE SENSOR
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Dehydration (1807); Hyperglycemia (1905)
Event Date 10/01/2018
Event Type  Injury  
Event Description
Hospitalized due to high blood sugar. Acute kidney failure and severe dehydration brought on due to misreadings of the freestyle libre continuous glucose monitor. Cgm read 200 below my actual blood sugar.
 
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Brand NameFREESTYLE LIBRE
Type of DeviceFREESTYLE LIBRE
Manufacturer (Section D)
ABBOTT DIABETES CARE
MDR Report Key7968886
MDR Text Key124117165
Report NumberMW5080560
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 10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberFREESTYLE LIBRE SENSOR
Device Catalogue NumberCODE H69
Device Lot NumberH69
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

Patient Treatment Data
Date Received: 10/15/2018 Patient Sequence Number: 1
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