FreeStyle Libre 2 71992Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 2 Flash Glucose Monitoring System Sensor · Class 2
Quick summary
This FreeStyle Libre 2 sensor has 17,204 adverse event reports in the FDA database, including 1 death and 4,754 injuries. Reports mostly describe incorrect or imprecise glucose readings, sensors that cannot give readings, wrong on-screen messages, and sensors that detach. Reports in the last 12 months (3,284) are far higher than in the 12 months before (905). 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
- 23,063
- Deaths reported
- 1
- Injuries reported
- 4,759
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23,063 adverse event reports that list this exact device (DI 00357599800000), received between Sep 18, 2020 and Sep 30, 2026 — classified as 1 death, 4,759 injuries, 18,303 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (16,855 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 Readings16,855
- Device Displays Incorrect Message2,545
- Unable to Obtain Readings2,516
- Detachment of Device or Device Component1,231
- Device Alarm System834
- Low Readings714
- High Readings392
- Adverse Event Without Identified Device or Use Problem240
Patient problems
- No Clinical Signs, Symptoms or Conditions17,639
- Loss of consciousness2,262
- Hypoglycemia2,222
- Convulsion/Seizure768
- Hyperglycemia763
- Device Embedded In Tissue or Plaque622
- Dizziness485
- Insufficient Information473
Recent adverse event reports
The 25 most recent of 23,063 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50955132 ↗InjurySep 30, 2026Unable to Obtain Readings; Device Displays Incorrect Message
Patient problems: Hypoglycemia
MAUDE report 50953813 ↗MalfunctionSep 30, 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 53 mg/dL compared to readings of 200 mg/dL respectively obtained on a Meter and the results, when plotted on a Parkes Error Grid, fall into C Zone, showing difference in values to be clinically significant. The length of sensor wear was 4 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 50946446 ↗MalfunctionSep 30, 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 64.00 mg/dL compared to readings of 172.00 mg/dL respectively obtained on a meter and the results, 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 7 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 50943968 ↗MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929337 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50926223 ↗MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926045 ↗MalfunctionSep 28, 2026Low Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925952 ↗MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925951 ↗MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925292 ↗MalfunctionSep 28, 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 "[130mg/dL]" compared to glucose values of "[60mg/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 50914871 ↗MalfunctionSep 28, 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 52 mg/dL compared to glucose values of 240 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 50912315 ↗MalfunctionSep 28, 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 "[100 mg/dL]" compared to glucose values of "[55 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 "[6 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 50911951 ↗MalfunctionSep 28, 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 50 mg/dL compared to readings of 188 mg/dL respectively obtained on a Competitor Brand Sensor and the results, 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 7 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 50911560 ↗MalfunctionSep 26, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906384 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906322 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906320 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906274 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906212 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906191 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906091 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906025 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904236 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904235 ↗MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903699 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.