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

Lot Number

Device Problem Incorrect, Inadequate or Imprecise Result or 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).

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABS / ABBOTT DIABETES CARE INC.
• MDR Report Key: 12040482
• MDR Text Key: 258052787
• Report Number: MW5102005
• Device Sequence Number: 7
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2021

Device Lot Number

• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 59