FreeStyle Libre 3 Plus 78769 (UDI 00357599843014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 472 adverse event reports that list this exact device (DI 00357599843014), received between Sep 2, 2025 and Sep 29, 2026 — classified as 14 injuries, 458 malfunctions.

The most frequently reported specific device problem is “Low Readings” (267 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.

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-1022-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 472 reports, in the reporter's own words as published by the FDA.

• 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 50.00 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 the C Zone, showing the difference in values to be clinically significant. The length of sensor wear was 1 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 50933498 ↗
• 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 50.00 mg/dL compared to readings of 150.00 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 50930024 ↗
• MalfunctionSep 25, 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 56.00 mg/dL compared to readings of 162.00 mg/dL respectively obtained on a HCP 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 50894456 ↗
• InjurySep 24, 2026Unable to Obtain Readings; Device Displays Incorrect Message

  Patient problems: Loss of consciousness

  MAUDE report 50891895 ↗
• MalfunctionSep 24, 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 compared to readings of 160 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 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 50883250 ↗
• MalfunctionSep 24, 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 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 50882059 ↗
• MalfunctionSep 23, 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 237.00 mg/dL compared to readings of 110.00 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 50864831 ↗
• MalfunctionSep 22, 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 47.00 mg/dL compared to readings of 240.00 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 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 50851845 ↗
• 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 64.00 mg/dL, 54.00 mg/dL compared to readings of 220.00 mg/dL, 330.00 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 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 50836573 ↗
• 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 60 mg/dL compared to readings of 291 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 12 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 50836422 ↗
• 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 59 mg/dL compared to readings of 171 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 50836262 ↗
• MalfunctionSep 21, 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 50835451 ↗
• MalfunctionSep 20, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834719 ↗
• MalfunctionSep 19, 2026Detachment of Device or Device Component

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50831959 ↗
• MalfunctionSep 18, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831064 ↗
• MalfunctionSep 18, 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 50817547 ↗
• MalfunctionSep 18, 2026Device Alarm System

  A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50814599 ↗
• MalfunctionSep 18, 2026Device Alarm System

  A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50814136 ↗
• MalfunctionSep 18, 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 50813569 ↗
• 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 50804648 ↗
• 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 213 mg/dL compared to glucose values of 94 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 50802589 ↗
• 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 50799811 ↗
• MalfunctionSep 17, 2026Device Alarm System

  A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. 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 50799571 ↗
• 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 72 mg/dL compared to glucose values of 217 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 50798292 ↗
• 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 89.00 mg/dL compared to glucose values of 318.00 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 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 50798029 ↗