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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE, INC. FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 71940
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
Libre sensor from abbott blood glucose reading read 48. Blood glucose meter and finger stick read 105. Variance of 57 points. Completely unacceptable. Upon contacting abbott libre help line (b)(6), i was informed that abbott does not guarantee their libre sensors to work correctly on any given sensor. I was informed that in order to verify the correct readings for the libre sensor, that i should take my blood glucose reading the old-fashioned way by a finger stick. It is ridiculous that abbott expects their consumers to take finger sticks with another system in order to verify the accuracy of their libre sensor. Take the sensor off of the market! it is not reliable! even abbott does not guarantee that their product will work. Inaccurate blood glucose monitoring can become a life or death situation. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE, INC.
MDR Report Key12624387
MDR Text Key276462268
Report NumberMW5104558
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 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Model Number71940
Device Catalogue Number71940
Device Lot Number210727Q
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

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