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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 72081-01
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hyperglycemia (1905); Tachycardia (2095)
Event Date 10/31/2022
Event Type  Injury  
Event Description
The spouse of a customer reported via email an unspecified error message with the adc device.The reporter indicated that the customer was experiencing symptoms of shortness of breath and rapid heart rate, and no sensor readings were able to be obtained when scanning sensor.The reporter then obtained a capillary glucose result of "higher than 600 mg/dl" and treated with customer with 20 iu insulin (type unknown), and additionally treated customer with inhaler.There was no report of death or permanent injury 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 the incident occurred 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 fs libre reader with the fs libre 3 sensor.The device manufacturing 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
The spouse of a customer reported via email an unspecified error message with the adc device.The reporter indicated that the customer was experiencing symptoms of shortness of breath and rapid heart rate, and no sensor readings were able to be obtained when scanning sensor.The reporter then obtained a capillary glucose result of "higher than 600 mg/dl" and treated with customer with 20 iu insulin (type unknown), and additionally treated customer with inhaler.There was no report of death or permanent injury associated with this event.
 
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.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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.
 
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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 Key15874946
MDR Text Key304415559
Report Number2954323-2022-43382
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
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 01/27/2023
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 Model Number72081-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/31/2022
Initial Date FDA Received11/28/2022
Supplement Dates Manufacturer Received01/19/2023
Supplement Dates FDA Received01/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2022
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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