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U.S. Department of Health and Human Services

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

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ABBOTT LABS / ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAY SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 0M000FQK0Q0
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
Alteration in management; in multiple uses of the freestyle libre 14 day cgm, i have had at least 4 calls to the manufacturer regarding very faulty readings. I have sent back 4 sensors. Get replacements with the same problems. E. G. This a. M. At 7:17 a. M. Scan read 48 mg/dl with arrow pointing downward. Fingerstick with one touch ultra 2 at 7:19 a. M. Noted a blood sugar of 90 mg/dl. Obviously, more than a 20% differential. I started using this device in (b)(6) of this year and all it is good for is "trends". And, yes, i know it is supposedly measuring "interstitial glucose" vs "blood glucose" but the unreliability is very bad. The cgm readings are consistently at least 20 points lower than actual blood stick readings. I have spoken to the "experts" at the freestyle customer support # on at least 4 occasions. The sensor is in the correct position. I am using the correct version of the app on my iphone. I am careful dressing so as not to jostle the sensor. Bottom line? this product is not ready for prime time. It is too inconsistent with actual finger stick readings. Before i realized that there might be a problem with the sensor readings, i would panic with low readings and start shoving sugar sources into my mouth, then when i realized the sensor readings were jumping up, as they should have, i started to pay closer attention. Before doing anything, i would then recheck my level with a finger stick and note that my blood sugars were okay. As much as i love not having to prick my fingers all the time, i am probably going to have to go back to it unless abbott can figure out what the problem is. I happened to mention this to my trainer, who has a client who also uses these sensors. She said that he was also having problems with low readings and was constantly having to change his sensor as a result. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAY
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT LABS / ABBOTT DIABETES CARE INC.
MDR Report Key12040482
MDR Text Key258052787
Report NumberMW5102005
Device Sequence Number2
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 06/17/2021
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Lot Number0M000FQK0Q0
Was Device Available for Evaluation? No Answer Provided
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: 06/21/2021 Patient Sequence Number: 1
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