FreeStyle Libre 2 Plus 78749 (UDI 00357599836009)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00357599836009), received between Sep 20, 2024 and Sep 8, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679018 ↗
• MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673418 ↗
• MalfunctionSep 1, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542421 ↗
• MalfunctionAug 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 300.00 mg/dL,150.00 mg/dL,165.00 mg/dL,250.00 mg/dL compared to glucose values of 160.00 mg/dL,90.00 mg/dL,105.00 mg/dL,123.00 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 50490985 ↗
• MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50490183 ↗
• MalfunctionAug 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 40.00 mg/dL compared to glucose values of 170.00 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 50428672 ↗
• MalfunctionJul 28, 2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057178 ↗
• MalfunctionJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50048855 ↗
• MalfunctionJul 10, 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 MG/DL, 44 MG/DL, 40 MG/DL COMPARED TO GLUCOSE VALUES OF 97 MG/DL, 100 MG/DL, 199 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 25778461 ↗
• MalfunctionJul 7, 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 GLUCOSE VALUES OF 259 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 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 25732211 ↗
• MalfunctionMay 12, 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 48.00 MG/DL COMPARED TO READINGS OF 156.00 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 25151269 ↗
• MalfunctionApr 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 50.00 MG/DL, AND 81.00 MG/DL COMPARED TO READINGS OF 262.00 MG/DL, AND 209.00 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 24982601 ↗
• MalfunctionApr 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 61.00 MG/DL COMPARED TO READINGS OF 191.00 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 24869801 ↗
• MalfunctionNov 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, 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 181 MG/DL AND 181MG/DL COMPARED TO READINGS OF 80 MG/DL AND 59MG/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 23451431 ↗
• InjuryFeb 4, 2025High Readings; High Readings

  A HIGH GLUCOSE READINGS ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE WAS REPORTED. THE CUSTOMER RECEIVED UNSPECIFIED HIGHER SENSOR SCAN RESULTS COMPARED TO UNSPECIFIED READINGS OBTAINED ON A COMPETITOR BRAND METER. IT IS UNKNOWN WHETHER THE CUSTOMER NOTED A TREND ARROW ON THE DEVICE. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER CONSULTED WITH A HEALTHCARE PROFESSIONAL (HCP) WHERE THE CUSTOMER'S BLOOD GLUCOSE WAS MEASURED AND OBTAINED A GLUCOSE READING OF 23 MG/DL. THE CUSTOMER WAS THEN PROVIDED WITH 100 MG OF GLUCOSE AS TREATMENT FOR THE DIAGNOSIS OF HYPOGLYCEMIA BY AN HCP. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 21304077 ↗
• MalfunctionSep 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO C ZONE AND THE LENGTH OF THE SENSOR WEAR WHEN THE ISSUE OCCURRED WAS DAY 14. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320335 ↗
• MalfunctionSep 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267065 ↗