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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 Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452); Shaking/Tremors (2515); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 01/04/2023
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 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
An error message was reported with the adc device.Customer received an "unknown error" message and was unable to obtain readings.As a result, customer experienced "cold sweat, tremors, spasms" and loss of consciousness.Customer was unable to self-treat and was treated with sugar drink and cocoa powder by a non-healthcare professional.No further information was provided.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.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 adc device.Customer received an "unknown error" message and was unable to obtain readings.As a result, customer experienced "cold sweat, tremors, spasms" and loss of consciousness.Customer was unable to self-treat and was treated with sugar drink and cocoa powder by a non-healthcare professional.No further information was provided.There was no report of death or permanent injury associated with this event.
 
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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 Key16284546
MDR Text Key308646766
Report Number2954323-2023-05209
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K213996
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 03/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2023
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
Date Manufacturer Received03/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2023
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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