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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 High Readings (2459)
Patient Problems Hypoglycemia (1912); Blurred Vision (2137); Shaking/Tremors (2515); Convulsion/Seizure (4406)
Event Date 03/17/2024
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 in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A high readings issue was reported with the abbott diabetes care (adc) device.The customer received unspecified high sensor scan results compared to readings obtained on a competitor's brand meter.The customer experienced symptoms described as "severe shaking, fingers and arms tingled, the soles of feet burned, blurred vision, hands were cramped, could not grab anything", and a seizure.The customer was unable to self-treat and had contact with a healthcare professional who provided cola for the diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor 0fw6e2840 has been returned and investigated.Visual inspection has been performed and no issues were observed on sensor patch.Data was downloaded successfully, sensor state 7 with event log 11 and sensor state 8 with event log 9 are an indication that the sensor had terminated due to an error recognized by the sensor.This is a part of software design and is not an indication of product non-conformance.Watermark was observed at the base of the sensor tail.De-cased the returned sensor and performed visual inspection of the printed circuit board assembly (pcba), damage to the antenna was observed.Attempted to communicate the sensor with evaluation module (evm) before source measure unit (smu) testing but was unable to do so due to inventory command fail message observed.Extended investigation and visual inspection has been performed on the returned de-cased sensor, observed that the antenna and molex connector had been damaged during de-casing and is unable to be re-soldered/repaired due to the solder pads coming away from the pcba.This damage will render the antenna unable to communicate.Unable to perform functionality testing without the antenna connected and will be unable to continue investigation as sensor is no longer in its original condition or a condition to perform functionality testing.Therefore, this issue is unable to test.Section h6 (investigation findings) code c20 (no findings available) and d15 cause not established was selected, as adc was unable to perform further testing on the returned device.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A high readings issue was reported with the abbott diabetes care (adc) device.The customer received unspecified high sensor scan results compared to readings obtained on a competitor's brand meter.The customer experienced symptoms described as "severe shaking, fingers and arms tingled, the soles of feet burned, blurred vision, hands were cramped, could not grab anything", and a seizure.The customer was unable to self-treat and had contact with a healthcare professional who provided cola for the diagnosis of hypoglycemia.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 94502-7001
5107495297
MDR Report Key18981848
MDR Text Key338634996
Report Number2954323-2024-10041
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K212132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
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 Received03/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/18/2024
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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