• 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. ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT 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. ABBOTT DIABETES CARE INC. FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number FREE STYLE LIBRE 14 DAYS
Device Problem Low Readings (2460)
Patient Problem Hyperglycemia (1905)
Event Date 11/06/2020
Event Type  malfunction  
Event Description
Libre free style 14 days sensor repeatedly showed low sugar not responding to po large amount sugar intake. Finally bought accuchek and blood sugar was in 160-180 mg/dl. The next 2 sensors were also showing lower sugar by 40 mg than with blood sugar accucheks. The whole batch if 6 sensors are defective. New sensor from different batch is correctly showing sugar. This was notified to abbott free style 3 times in past and again today after realizing that whole batch is defective. Therapy date: (b)(6) 2020. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameABBOTT DIABETES CARE INC. FREE STYLE LIBRE 14 DAYS SENSOR ABBOTT
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key10975652
MDR Text Key220689756
Report NumberMW5098259
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/04/2020
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberFREE STYLE LIBRE 14 DAYS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/08/2020 Patient Sequence Number: 1
-
-