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 71988-01
Device Problem Low Readings (2460)
Patient Problems Fall (1848); Hyperglycemia (1905); Dizziness (2194); Loss of consciousness (2418)
Event Date 06/07/2022
Event Type  Injury  
Event Description
A customer reported a low reading issue with the adc device.The customer reported an unspecified low sensor reading, was dizzy, frequently urinating, "collapsed" 4 times, and eventually lost consciousness.An ambulance was called and customer taken to hospital where they were put on iv to treat diagnosis of hyperglycemia.No further details were provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specification.Dhrs (device history record) for the freestyle libre sensor and freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported a low reading issue with the adc device.The customer reported an unspecified low sensor reading, was dizzy, frequently urinating, "collapsed" 4 times, and eventually lost consciousness.An ambulance was called and customer taken to hospital where they were put on iv to treat diagnosis of hyperglycemia.No further details were provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.All pertinent information available to abbott diabetes care has been submitted.
 
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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key14713701
MDR Text Key294274512
Report Number2954323-2022-19713
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/13/2022
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 Date03/31/2023
Device Model Number71988-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 06/09/2022
Initial Date FDA Received06/16/2022
Supplement Dates Manufacturer Received11/15/2022
Supplement Dates FDA Received12/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-