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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 Detachment of Device or Device Component (2907)
Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Event Date 03/09/2023
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.At this time product has not yet been returned.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.The device history records (dhrs) for the fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered is "one week ago" prior to 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 a customer reported an adhesive issue with the abbott diabetes care (adc) sensor.The sensor prematurely detached after one day of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced "disoriented", "sweat", "can no longer talk", and was unable to self-teat, requiring a third-party blood glucose measurement (result unspecified) and third-party treatment of "candy to eat" and unspecified "drink" provided by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
 
Event Description
A webform complaint was received in which a customer reported an adhesive issue with the abbott diabetes care (adc) sensor.The sensor prematurely detached after one day of wear and the customer was unable to obtain readings and monitor glucose levels.As a result, customer experienced "disoriented", "sweat", "can no longer talk", and was unable to self-teat, requiring a third-party blood glucose measurement (result unspecified) and third-party treatment of "candy to eat" and unspecified "drink" provided by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.No physical damage was observed on the sensor patch.Adhesive was not returned.If the adhesive 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 Key16634490
MDR Text Key312193112
Report Number2954323-2023-12516
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 04/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2023
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 Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received04/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2022
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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