FreeStyle Libre 14 day 71940Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 14 day Sensor Kit · Class 3
All models of FreeStyle Libre 14 day (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This FreeStyle Libre 14 day sensor kit has 16,074 adverse event reports in the FDA database, including 1 death and 2,770 injuries. Reports mostly describe incorrect or imprecise glucose readings, sensors that cannot give readings, and wrong on-screen messages. Reports in the last 12 months (429) are well above the 12 months before (170). 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
- 16,002
- Deaths reported
- 1
- Injuries reported
- 2,770
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16,002 adverse event reports that list this exact device (DI 00357599001018), received between Dec 13, 2018 and Sep 30, 2026 — classified as 1 death, 2,770 injuries, 13,231 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (13,181 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. 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
- Incorrect, Inadequate or Imprecise Result or Readings13,181
- Device Displays Incorrect Message865
- Unable to Obtain Readings765
- Low Readings564
- Appropriate Device Problem Term/Code Not Available541
- Detachment of Device or Device Component332
- High Readings229
- Adverse Event Without Identified Device or Use Problem144
Patient problems
- No Clinical Signs, Symptoms or Conditions12,537
- Loss of consciousness889
- Hypoglycemia798
- No Known Impact Or Consequence To Patient634
- Hyperglycemia591
- Skin Irritation358
- Dizziness253
- Insufficient Information235
Recent adverse event reports
The 25 most recent of 16,002 reports, in the reporter's own words as published by the FDA.
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 70.00 mg/dL,80.00 mg/dL compared to readings of 300.00 mg/dL,300.00 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 unknown 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 50943860 ↗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 69 mg/dL compared to readings of 286 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 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 50943574 ↗MalfunctionSep 29, 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 67.00 mg/dL compared to readings of 200.00 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 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 50931834 ↗MalfunctionSep 29, 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 101.00 mg/dL compared to readings of 241.00 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 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 50929338 ↗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 200 mg/dL compared to readings of 100 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 unknown. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913201 ↗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 50802353 ↗MalfunctionSep 15, 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 500 mg/dL compared to glucose values of 120 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 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 50767671 ↗MalfunctionSep 14, 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 42 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 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 50750110 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50559226 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558542 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558516 ↗MalfunctionSep 2, 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 182.00 mg/dL compared to glucose values of 86.00 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 50558080 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50557997 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50557983 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50557979 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50557906 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50556585 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50556330 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50556151 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50556132 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50556090 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555883 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555599 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555395 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555389 ↗
Other Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated devices
- FreeStyle Libre 71536Abbott Diabetes Care Inc · Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated640 reports
- FreeStyle Libre 14 day 71938Abbott Diabetes Care Inc · Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated1 recall578 reports
- FreeStyle Libre 14 day 71937Abbott Diabetes Care Inc · Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated1 recall82 reports
- FreeStyle LibreLink 71732-01Abbott Diabetes Care Inc · Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated111 reports
- FreeStyle LibreLink 71733-01Abbott Diabetes Care Inc · Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated92 reports
- FreeStyle Libre 14 day 71939Abbott Diabetes Care Inc · Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated78 reports
- FreeStyle Libre 71525Abbott Diabetes Care Inc · Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated1 recall18 reports
- FreeStyle Libre 14 day 71936Abbott Diabetes Care Inc · Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated1 recall9 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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