FreeStyle Libre 2 Plus 78747 (UDI 00357599835019)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,833 adverse event reports that list this exact device (DI 00357599835019), received between Oct 16, 2025 and Sep 30, 2026 — classified as 97 injuries, 1,736 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,512 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,833 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 50953814 ↗
• 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 46 mg/dL compared to readings of 249 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 50949349 ↗
• 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 210.00 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 50944676 ↗
• 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 66.00 mg/dL,68.00 mg/dL compared to readings of 172.00 mg/dL,202.00 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 8 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 50944671 ↗
• 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 103.00 mg/dL compared to readings of 249.00 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 50944336 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943513 ↗
• 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 and 58.00 mg/dL compared to readings of 258.00 mg/dL and 240.00 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 50935928 ↗
• 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 57 mg/dL compared to readings of 220 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 50931744 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930492 ↗
• 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 53 mg/dL compared to readings of 162 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 50929666 ↗
• 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 41 mg/dL compared to readings of 269 mg/dL respectively obtained on a 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 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 50929468 ↗
• 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 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 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 50929326 ↗
• 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 70.00 mg/dL compared to readings of 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 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 50929099 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929098 ↗
• 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 51.00 mg/dL compared to readings of 202.00 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 50928926 ↗
• InjurySep 29, 2026Unable to Obtain Readings; Device Displays Incorrect Message

  An unspecified sensor error message was reported with the Abbott Diabetes Care (ADC) device and customer was unable to obtain readings. The customer did not report any symptoms but an ambulance was called. Upon arrival, a glucose reading of 32 mg/dL was obtained on unknown device. The ambulance staff attempted intravenous insertion multiple times; the customer resisted, fell from chair, but recovered after oral glucose medication within 5-10 minutes. There was no report of death or permanent impairment associated with this event.

  Patient problems: Hypoglycemia

  MAUDE report 50927102 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50926261 ↗
• 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 55.00 mg/dL compared to readings of 261.00 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 9 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 50914818 ↗
• 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 350 mg/dL and 360 mg/dL compared to readings of 107 mg/dL and 60 mg/dL respectively obtained on a 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 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 50913204 ↗
• 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 60 mg/dL compared to readings of 268 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 50913193 ↗
• 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 51 mg/dL compared to readings of 368 mg/dL respectively obtained on a 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 14 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 50912387 ↗
• 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 83.00 mg/dL compared to readings of 361.00 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 50911761 ↗
• 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 45.00 mg/dL compared to readings of 355.00 mg/dL respectively obtained on a 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 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 50911591 ↗
• 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 56.00 mg/dL compared to readings of 264.00 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 50911543 ↗
• 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 298 mg/dL compared to readings of 106 mg/dL respectively obtained on an Other Consumer Non-ADC Product 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 50911023 ↗