FreeStyle Libre 2 Plus 78749 (UDI 00357599836016)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00357599836016), received between Jun 24, 2026 and Sep 17, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 120.00 mg/dL compared to readings of 355.00 mg/dL respectively obtained on a 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 15 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 50801349 ↗
• MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501965 ↗
• InjuryAug 27, 2026Low Readings

  A low readings issue with the Abbott Diabetes Care (ADC) device was reported. The customer received an unspecified low scan on the ADC device. It is unknown whether the customer noted a trend arrow on the device. The customer was asymptomatic and was unable to self-treat. The customer had contact with healthcare professional (HCP) who obtained blood glucose result of 381 mg/dL and required administration of insulin injection (dose/type unknown) for the diagnosis of hyperglycemia. There was no report of death or permanent impairment associated with this event.

  Patient problems: Hyperglycemia

  MAUDE report 50483199 ↗
• MalfunctionAug 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 3.30 mmol/L compared to glucose values of 10.30 mmol/L 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 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 50259866 ↗
• MalfunctionJun 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 56.00 MG/DL COMPARED TO READINGS OF 182.00 MG/DL RESPECTIVELY OBTAINED ON A ADC 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 25612674 ↗