FreeStyle Libre 3 72079 (UDI 00357599820015)Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 3 Continuous Glucose Monitoring System Reader · Class 2
All models of FreeStyle Libre 3 (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is the FreeStyle Libre 3 reader, the handheld unit that reads the Abbott continuous glucose monitoring sensor. The 27 reports filed since February 2026 mostly describe the reader giving unexpected or missing high and low glucose alarms, along with display glitches and one unit that would not power on; three reports mention injuries, and no deaths were reported. All 27 reports came in the past 12 months, with none in the 12 months before that. 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
- 59
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00357599820015), received between Feb 4, 2026 and Sep 29, 2026 — classified as 4 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (27 reports).
2 other recalls cover devices cleared under the same FDA submission (K223435, K233537); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Alarm System27
- Product Quality Problem26
- Incorrect, Inadequate or Imprecise Result or Readings3
- Failure to Power Up2
- Image Display Error/Artifact1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Hyperglycemia3
- Convulsion/Seizure1
- Hypoglycemia1
- Loss of consciousness1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Product Quality Problem
The customer reports overheating from their Abbott Diabetes Care device. The customer further reports product gets hot when charging. 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 50933330 ↗MalfunctionSep 23, 2026Product Quality Problem
The customer reported fire from their Abbott Diabetes Care device. The customer further reports the cable melted in the outlet. There was no report of 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 50871437 ↗MalfunctionSep 21, 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 50835866 ↗MalfunctionSep 21, 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 50835083 ↗MalfunctionSep 18, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831250 ↗MalfunctionSep 18, 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 164mg/dL compared to glucose values of 53mg/dL respectively obtained on the comparison device, when plotted on a Parkes Error Grid, fall into the D 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 50816494 ↗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 50815876 ↗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 50815827 ↗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 50814270 ↗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 50802583 ↗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 50802579 ↗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 50802506 ↗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 50802359 ↗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 50802239 ↗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 50802094 ↗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 50801119 ↗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 50800889 ↗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 50800560 ↗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 50799501 ↗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 50799416 ↗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 50799330 ↗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 50798799 ↗InjurySep 17, 2026Device Alarm System
A missing low alarm issue was reported with the Abbott Diabetes Care (ADC) device. The low glucose alarms did not sound and the customer was not alerted of changes in glucose level. The customer experienced hypoglycemia, went to the emergency room (ER), and received unspecified third-party treatment. It was indicated that the customer also had a high glucose reading "over 200."There was no report of death or permanent impairment associated with this event.
Patient problems: Hypoglycemia
MAUDE report 50797415 ↗MalfunctionSep 16, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790435 ↗MalfunctionSep 16, 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 50789332 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223435, K233537. One submission often covers many models, so check the product and lot details in each record.
- Z-1021-2026 · Nov 24, 2025 · Open, ClassifiedFreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring Syst
- Z-1022-2026 · Nov 24, 2025 · Open, ClassifiedFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring Syst
Other System, test, blood glucose, over the counter devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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