Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; SENSOR, GLUCOSE, INVASIVE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 14 DAY SENSOR
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2019
Event Type  malfunction  
Event Description
My husband uses the freestyle libre 14 day sensor and this is the second time that he has gotten a defective sensor.These sensors are not cheap, my husband is on disability and i am retired so we are on a fixed income and can't afford to replace the defective one because we would have to purchase 2 of them and that is (b)(6).The code number is h78, sn # (b)(4), expiration date: 10/31/2019.I tried calling abbott and they said that they couldn't do anything about it, that i needed to talk to freestyle libre.My husband has to go back to sticking his finger until it's time to refill the sensors again.This is very frustrating for us.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FREESTYLE LIBRE
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key8695917
MDR Text Key148067563
Report NumberMW5087314
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 Family Member or Friend
Type of Report Initial
Report Date 06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/31/2019
Device Model Number14 DAY SENSOR
Device Lot Number190317P
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/12/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age59 YR
Patient Weight109
-
-