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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures (2063)
Event Date 11/15/2020
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 experiencing bleeding after applying the adc freestyle libre sensor.Customer further reported experiencing a "seizure in one leg" and self-treating with insulin.No third-party treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
(device mfg date) were updated based on extended investigation.No product has been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed.
 
Event Description
Customer reported experiencing bleeding after applying the adc freestyle libre sensor.Customer further reported experiencing a "seizure in one leg" and self-treating with insulin.No third-party treatment was reported.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(6)has been returned and investigated.Visual inspection has been performed on the returned sensor and no issues were observed.The sensor plug was properly seated, and no failure modes were observed with the sensor plug on visual inspection.No malfunction or product deficiency was identified.The sensor applicator has not been returned therefore, further investigation cannot be performed.If the sensor applicator is returned, the case will be re-opened, and a physical investigation will be performed all pertinent information available to abbott diabetes care has been submitted.Additional information - section g1: (contact office first name, contact office last name, contact office phone number and contact office email) has been updated.
 
Event Description
Customer reported experiencing bleeding after applying the adc freestyle libre sensor.Customer further reported experiencing a "seizure in one leg" and self-treating with insulin.No third-party 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 Key10932001
MDR Text Key219128505
Report Number2954323-2020-12429
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,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer01/11/2021
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received12/02/2020
Supplement Dates Manufacturer Received12/08/2020
02/08/2021
Supplement Dates FDA Received12/18/2020
03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight68
-
-