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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 72114-01
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Loss of consciousness (2418); Convulsion/Seizure (4406)
Event Date 12/23/2022
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 date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.N/a was selected for g4 as it is unknown if the user was using android, ios, or a reader with the fs libre 3 sensor.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
A webform complaint was received in which it was reported a customer received a "replace sensor" message on the adc device and was unable to obtain readings.As a result, customer experienced loss of consciousness and/or seizure and required third-party treatment in the form of juice, sugar, or food by a non-healthcare professional.No further details were provided and attempts to gather additional information were unsuccessful.There was no report of death or permanent impairment associated with this event.
 
Event Description
A webform complaint was received in which it was reported a customer received a "replace sensor" message on the adc device and was unable to obtain readings.As a result, customer experienced loss of consciousness and/or seizure and required third-party treatment in the form of juice, sugar, or food by a non-healthcare professional.No further details were provided and attempts to gather additional information were unsuccessful.There was no report of death or permanent impairment 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.There was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product 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.This serves as a correction report as the initial mdr report inadvertently was missing the extended investigation on the reported sensor.H6 adverse event problem and h10 - addtl mfg narrative have been updated to include extended investigation findings.Section h-4 (device mfg date) has been updated.
 
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Brand Name
FREESTYLE LIBRE 3
Type of Device
CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD
range road
witney 12345 -700
UK  12345-7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key16073858
MDR Text Key306405343
Report Number2954323-2022-47555
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
VERIFY
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 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/28/2023
Device Model Number72114-01
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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