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 2; FLASH GLUCOSE MONITORING SYSTEM
  • 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 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Seizures (2063); Dizziness (2194); Loss of consciousness (2418)
Event Date 10/28/2020
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported her adc freestyle libre 2 sensor detached from the adhesive prematurely and she was therefore unable to monitor her glucose.Customer reported experiencing dizziness, seizure and loss of consciousness and self-treating with insulin, cola, and sweets.In addition, the customer received glucose treatment from a third-party.No further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Additional information: section h4 (device mfg date) was updated based on returned product download.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor kit passed all tests prior to release.Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed on the sensor patch and returned adhesive.Therefore, it is not confirmed.
 
Event Description
Customer reported her adc freestyle libre 2 sensor detached from the adhesive prematurely and she was therefore unable to monitor her glucose.Customer reported experiencing dizziness, seizure and loss of consciousness and self-treating with insulin, cola, and sweets.In addition, the customer received glucose treatment from a third-party.No further treatment was reported.There was no report of death or permanent injury associated with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key10820792
MDR Text Key215888247
Report Number2954323-2020-10326
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date12/31/2021
Device Model Number71992-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight62
-
-