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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 Problem Failure to Fire (2610)
Patient Problems Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418)
Event Date 08/13/2022
Event Type  Injury  
Event Description
A customer reported that inserter of the adc device did not fire and therefore was unable to apply sensor.The customer was unable to monitor glucose and became dizzy, subsequently losing consciousness.The customer was provided soda for treatment by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.N/a was selected as it is unknown if the user was using android, ios, or a fs libre reader with the fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported that inserter of the adc device did not fire and therefore was unable to apply sensor.The customer was unable to monitor glucose and became dizzy, subsequently losing consciousness.The customer was provided soda for treatment by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor 09ecx05tq has been returned and investigated.Visual inspection has been performed on sensor patch and no issues were observed.No further investigation can be performed as the sensor applicator has not been returned.If additional product is returned, an investigation will be performed.Therefore, the issue is closed to no product returned.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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor kits were reviewed and the dhrs showed the libre sensor kits 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.
 
Event Description
A customer reported that inserter of the adc device did not fire and therefore was unable to apply sensor.The customer was unable to monitor glucose and became dizzy, subsequently losing consciousness.The customer was provided soda for treatment by a non-healthcare professional.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 Key15280433
MDR Text Key298454498
Report Number2954323-2022-30602
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,Followup
Report Date 09/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2023
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received09/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2022
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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