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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE 14 DAY SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 190724P
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2019
Event Type  Injury  
Event Description
Patient called to report an adverse event involving his freestyle libre 14 day sensor. Patient stated on (b)(6) 2019, he put a new senor on, waited the correct time, and then received a higher than normal reading of 193. Patient said he waited an hour and took another reading and it went even higher into the 200¿s. Patient said he checked his blood sugar with test strips again and was only at 109. Patient stated he took a few more readings and all were over 200. Patient said he checked his blood sugar with the test strips again and it was only in the 80¿s. Patient said the sensor is completely off and consistently reading too high. Patient said he¿s previously reported this issue to abbott and has had this happen with at least 5 different sensors.
 
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Brand NameFREESTYLE LIBRE 14 DAY SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key9410912
MDR Text Key169579070
Report NumberMW5091421
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 12/03/2019
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Lot Number190724P
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 12/03/2019 Patient Sequence Number: 1
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