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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 Insufficient Information (3190)
Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406)
Event Date 01/17/2023
Event Type  Injury  
Event Description
Customer reported an unspecified sensor problem and that the ¿sensor rusted¿ and as a result, provided wrong measured values after three days of wearing the adc device.The customer experienced cramps in legs, hands, and a seizure; customer self-treated with glucose.There was no report of death or permanent injury 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 and there was no indication that the product did not meet specification.Dhrs for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.It is unknown if the user was using android, ios, or a reader with the fs libre 3 sensor.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.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.No physical damage was observed on the returned sensor.Unable to perform further investigation due to applicator not returned.If the applicator 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
Customer reported an unspecified sensor problem and that the ¿sensor rusted¿ and as a result, provided wrong measured values after three days of wearing the adc device.The customer experienced cramps in legs, hands, and a seizure; customer self-treated with glucose.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 Key16381052
MDR Text Key309601631
Report Number2954323-2023-06940
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 04/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/30/2023
Device Model Number72081-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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