FreeStyle Libre 3 72080Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 3 Sensor Kit NFRS · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Abbott FreeStyle Libre sensor is a glucose monitor worn on the skin. Its 182 reports include no deaths and 65 injuries, and reports in the last 12 months (47) are up from 1 in the prior 12 months. Many describe inaccurate or unobtainable readings, and some mention low blood sugar, fainting or seizures. There is 1 open recall, started in November 2025, over possible incorrect low glucose readings.
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
- 274
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 00357599819002), received between Nov 5, 2022 and Sep 21, 2026 — classified as 65 injuries, 209 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (178 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 24, 2025Open, Classified
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Z-1023-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings178
- Device Displays Incorrect Message28
- Low Readings28
- Unable to Obtain Readings25
- Detachment of Device or Device Component17
- Device Alarm System10
- Adverse Event Without Identified Device or Use Problem6
- High Readings3
Patient problems
- No Clinical Signs, Symptoms or Conditions208
- Hypoglycemia29
- Loss of consciousness22
- Hyperglycemia13
- Convulsion/Seizure8
- Dizziness8
- Skin Infection6
- Headache5
Recent adverse event reports
The 25 most recent of 274 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 50 mg/dL compared to glucose values of 200 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 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 50835360 ↗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 55 mg/dL compared to glucose values of 158 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 5 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 50816259 ↗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 54 mg/dL compared to glucose values of 154 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 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 50814879 ↗MalfunctionSep 17, 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 350 mg/dL compared to glucose values of 173 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 50798428 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50711078 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50710993 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703537 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703457 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703324 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702475 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702294 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702208 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701821 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700574 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699337 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699177 ↗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 58.00 mg/dL compared to glucose values of 200.00 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 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 50699175 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698571 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697822 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697232 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695595 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695493 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694395 ↗MalfunctionSep 9, 2026Delivered as Unsterile Product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691569 ↗MalfunctionSep 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690755 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.