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 Unintended Power Up (1162); Unexpected Shutdown (4019)
Patient Problem Hypoglycemia (1912)
Event Date 07/10/2022
Event Type  Injury  
Event Description
A customer reported that the adc device would turn on and off by itself.Due to this issue the customer could not be alerted to changes in glucose via high/low glucose alarm, and the customer became hypoglycemic, requiring treatment of juice by a third-party.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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre reader were 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.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.A visual inspection of the returned reader revealed damage to the usb port.Due to the damaged usb port, the customer was unable to charge the reader.The reader de-cased and placed into the reader test.Therefore, this complaint is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported that the adc device would turn on and off by itself.Due to this issue the customer could not be alerted to changes in glucose via high/low glucose alarm, and the customer became hypoglycemic, requiring treatment of juice by a third-party.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
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key15065090
MDR Text Key296225136
Report Number2954323-2022-24862
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUK
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 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
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 Manufacturer Received12/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-