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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 14 DAY READER SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 14 DAY READER SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2020
Event Type  malfunction  
Event Description
Reader not working - 30 points different from fingerstick.
 
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Brand NameFREESTYLE LIBRE 14 DAY READER
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key9581015
MDR Text Key175091829
Report NumberMW5092173
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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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