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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Hyperglycemia (1905)
Event Date 07/11/2021
Event Type  malfunction  
Event Description
Incorrect blood sugar reading; took his blood sugar at 5:40 am this morning and freestyle libre sensor cgm said it was 40 so he ate. He then took his blood sugar again at 10:18 am the cgm said his blood sugar was 65 but he did not feel like his blood sugar was low. He has a standard finger stick blood glucose system and he used that at 10:08 am and i said his blood sugar was 195. This is his second sensor within two weeks to fail for different reasons abbot has not been very helpful into why we may be having repeated problems with the sensor. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key12166338
MDR Text Key261912305
Report NumberMW5102525
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/11/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
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

Patient Treatment Data
Date Received: 07/13/2021 Patient Sequence Number: 1
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