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 71953-01
Device Problems Erratic or Intermittent Display (1182); Data Problem (3196)
Patient Problems Loss of consciousness (2418); Confusion/ Disorientation (2553)
Event Date 05/25/2021
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet 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 reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred 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
A customer reported that the adc freestyle libre 2 reader button or switch sporadically it goes on its own and values are often not displayed and that the reader was not working.As a result, the customer experienced symptoms of disorientation and a loss of consciousness and was unable to self-treat however, no further information was reported.There was no report of death or permanent impairment associated with this event.
 
Event Description
A customer reported that the adc freestyle libre 2 reader button or switch sporadically it goes on its own and values are often not displayed and that the reader was not working.As a result, the customer experienced symptoms of disorientation and a loss of consciousness and was unable to self-treat however, no further information was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.A visual inspection was performed on the returned reader and no issues were observed.A built-in reader test was performed; all tests passed and functions cycled normally.No malfunction or product deficiency has been identified.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
MDR Report Key11938929
MDR Text Key254269567
Report Number2954323-2021-71352
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 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2021
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age51 YR
Patient Weight90
-
-