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 Device Displays Incorrect Message (2591)
Patient Problems Fatigue (1849); Hypoglycemia (1912); Confusion/ Disorientation (2553); Polydipsia (2604)
Event Date 12/01/2023
Event Type  Injury  
Event Description
An error message was reported with the abbott diabetes care (adc) device.Customer received a "scan again in 10 minutes" message and was unable to obtain readings.As a result, customer experienced "weakness" "feeling thirsty", "disorientation", and was unable to self-treat, requiring third-party treatment of "jam" orally by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.The available tripped trend reports were reviewed for libre sensor and perception code for the last year.The review identified a tripped trend for this perception code.This tripped trend was addressed in the tracking, trending review meeting, and investigated.The investigation concluded that the tripped trend was not correlated with a product nonconformance.Trends are regularly monitored and investigated when exceeding established thresholds to evaluate for causes associated with the product.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.Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number. therefore, section d4 was updated to unk.
 
Event Description
An error message was reported with the abbott diabetes care (adc) device.Customer received a "scan again in 10 minutes" message and was unable to obtain readings.As a result, customer experienced "weakness" "feeling thirsty", "disorientation", and was unable to self-treat, requiring third-party treatment of "jam" orally by a non-healthcare professional.There was no report of death or permanent impairment 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 Key18299634
MDR Text Key330110143
Report Number2954323-2023-53406
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFR
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 12/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-