FreeStyle Libre 3 72079 (UDI 00357599820008)Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 3 Continuous Glucose Monitoring System Reader · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Abbott FreeStyle Libre 3 reader appears in 264 adverse event reports, with no deaths and 61 injuries. The reports mostly describe unexpected or missing glucose alarms, failure to power up, and failed glucose readings, with some also listing low blood sugar, loss of consciousness or seizures. Reports rose to 179 in the last 12 months from 38 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 315
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 315 adverse event reports that list this exact device (DI 00357599820008), received between Dec 1, 2023 and Sep 28, 2026 — classified as 58 injuries, 257 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (163 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Alarm System163
- Product Quality Problem93
- Failure to Power Up21
- Unable to Obtain Readings20
- Incorrect, Inadequate or Imprecise Result or Readings12
- Device Displays Incorrect Message7
- High Readings5
- Premature Discharge of Battery5
Patient problems
- No Clinical Signs, Symptoms or Conditions259
- Loss of consciousness30
- Hypoglycemia25
- Hyperglycemia17
- Convulsion/Seizure9
- Dizziness9
- Confusion/ Disorientation5
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 315 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915003 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905906 ↗MalfunctionSep 25, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm issue with the Abbott Diabetes Care (ADC) device. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897529 ↗MalfunctionSep 25, 2026Device Alarm System
A customer reported a missing high/low glucose alarm with the ADC device. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896439 ↗MalfunctionSep 25, 2026Device Alarm System
A customer reported a missing high/low glucose alarm with the ADC device. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896231 ↗MalfunctionSep 24, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884253 ↗MalfunctionSep 24, 2026Product Quality Problem
The customer observed cord was burning from their Abbott Diabetes Care device. There was no report of fire, smoke, explosion, or shock. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882571 ↗MalfunctionSep 22, 2026Product Quality Problem
The customer reported overheating from their Abbott Diabetes Care device. The customer further reports "became hot during use". There was no report of fire, smoke, explosion, or shock. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857938 ↗MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings
A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received ADC meter results of 179 mg/dL compared to glucose values of 70 mg/dL respectively obtained on the comparison device, when plotted on a Parkes Error Grid, fall into the C Zone, showing the difference in values to be clinically significant. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852358 ↗MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings
A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received ADC meter results of "[90mg/dL]" compared to glucose values of "[51mg/dL]" respectively obtained on the comparison device, when plotted on a Parkes Error Grid, fall into the "[C]" Zone, showing the difference in values to be clinically significant. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850684 ↗MalfunctionSep 18, 2026Device Alarm System
A customer reported a missing high/low glucose alarm with the ADC device. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816241 ↗MalfunctionSep 18, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813120 ↗MalfunctionSep 17, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812233 ↗MalfunctionSep 17, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, or shock. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803018 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802446 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802210 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802161 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported a missing high/low glucose alarm with the ADC device. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800645 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800113 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported a missing high/low glucose alarm with the ADC device. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious, injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799913 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799857 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799333 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799171 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50798751 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797994 ↗
Other Integrated Continuous Glucose Monitoring system, factory calibrated devices
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- Dexcom G6 Sensor Applicator Assembly 9500-45Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall4 deaths114,678 reports
- US G6 Transmitter (Retail, Receiver Optional) STT-OE-002Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated76,977 reports
- Dexcom G7 GSS (161) 9500-161Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated70,146 reports
- Dexcom G7 iOS App SW12300Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 recalls1 death55,219 reports
- Dexcom G7 GSS (161) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
- G6 Medicare Transmitter STT-OM-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated38,339 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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