FreeStyle Libre 2 72000Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 2 Flash Glucose Monitoring System Sensor · Class 2
Quick summary
This FreeStyle Libre glucose sensor is worn on the skin to track blood sugar. The 358 reports mostly describe inaccurate readings, missing readings and wrong alarm messages, and some mention low blood sugar, loss of consciousness or seizures. The reports record 148 injuries, 210 malfunctions and no deaths. Reports rose from none in the year before to 22 in the last year. 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
- 453
- Deaths reported
- 0
- Injuries reported
- 148
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 453 adverse event reports that list this exact device (DI 00357599801007), received between Oct 28, 2020 and Sep 21, 2026 — classified as 148 injuries, 305 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (280 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
- Incorrect, Inadequate or Imprecise Result or Readings280
- Unable to Obtain Readings88
- Device Displays Incorrect Message83
- Detachment of Device or Device Component44
- Low Readings18
- Device Alarm System11
- Adverse Event Without Identified Device or Use Problem9
- High Readings3
Patient problems
- No Clinical Signs, Symptoms or Conditions291
- Loss of consciousness65
- Hypoglycemia55
- Insufficient Information29
- Hyperglycemia26
- Convulsion/Seizure20
- Dizziness15
- Device Embedded In Tissue or Plaque12
Recent adverse event reports
The 25 most recent of 453 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings
A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 55 mg/dL compared to glucose values of 493 mg/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. The length of sensor wear was 1 day. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835331 ↗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 sensor scan results of 45 mg/dL compared to glucose values of 150 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. The length of sensor wear was 1 day. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818839 ↗MalfunctionSep 16, 2026Detachment of Device or Device Component
A customer reported that an ADC device component detached and remained in skin. There was no indication that the customer required intervention from a healthcare professional to remove the component. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50782926 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50756929 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 105.00 mg/dL compared to glucose values of 227.00 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. The length of sensor wear is an unknown number of days. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728171 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50711591 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50707867 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50706624 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50705861 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 75.00 mg/dL,53.00 mg/dL compared to glucose values of 180.00 mg/dL,220.00 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. The length of sensor wear was same day. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703828 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701404 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701181 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700756 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699173 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698822 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695098 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692995 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692799 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692539 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691977 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691778 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691761 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
A customer reported receiving erroneous glucose results from an Abbott Diabetes Care device. The customer received sensor scan results of 54.00 mg/dL, 55.00 mg/dL compared to glucose values of 305.00 mg/dL, 305.00 mg/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. The length of sensor wear was 3 days. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691541 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691531 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691064 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.