FreeStyle Libre 3 Plus 78768 (UDI 00357599844011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18,890 adverse event reports that list this exact device (DI 00357599844011), received between Apr 25, 2025 and Sep 30, 2026 — classified as 1 death, 406 injuries, 18,483 malfunctions.

The most frequently reported specific device problem is “Low Readings” (10,141 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K222447, 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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-1021-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 18,890 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50954721 ↗
• MalfunctionSep 30, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953438 ↗
• MalfunctionSep 30, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953435 ↗
• MalfunctionSep 30, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953434 ↗
• InjurySep 30, 2026Low Readings

  Patient problems: Hyperglycemia

  MAUDE report 50953274 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951191 ↗
• 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 50.00 mg/dL compared to readings of 161.00 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 2 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 50951040 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950455 ↗
• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50948714 ↗
• 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 60 mg/dL compared to readings of 199 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 50947907 ↗
• 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 50 mg/dL compared to readings of 150 mg/dL respectively obtained on a Competitor Brand 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 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 50947482 ↗
• 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 53.00 mg/dL compared to readings of 174.00 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. There was no report of death, serious injury, or mistreatment associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947166 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947165 ↗
• 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 53.00 mg/dL compared to readings of 223.00 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 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 50946493 ↗
• 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 57 mg/dL compared to readings of 384 mg/dL respectively obtained on a Competitor Brand Meter and the results, 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 13 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 50946362 ↗
• 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 55.00 mg/dL compared to readings of 155.00 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 50946306 ↗
• 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 270 mg/dL and 250 mg/dL compared to readings of 88 mg/dL and 111 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 50946257 ↗
• 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 79.00 mg/dL compared to readings of 282.00 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 13 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 50946077 ↗
• 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 57 mg/dL compared to readings of 203 mg/dL respectively obtained on a Competitor Brand 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 50945830 ↗
• 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 397.00 mg/dL and 400.00 mg/dL compared to readings of 137.00 mg/dL and 135.00 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 10 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 50945644 ↗
• 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 400.00 mg/dL compared to readings of 129.00 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 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 50945388 ↗
• 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 50 mg/dL compared to readings of 150 mg/dL respectively obtained on a Competitor Brand 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 50944715 ↗
• 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 45.00 mg/dL compared to readings of 169.00 mg/dL respectively obtained on a Competitor Brand 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 50944488 ↗
• 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 52.00 mg/dL compared to readings of 202.00 mg/dL respectively obtained on a Competitor Brand 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 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 50944284 ↗
• 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 356 mg/dL compared to readings of 166 mg/dL respectively obtained on a Competitor Brand 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 11 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 50944218 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K222447, K233537. One submission often covers many models, so check the product and lot details in each record.

• Z-1022-2026 · Nov 24, 2025 · Open, Classified
  FreeStyle 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