FreeStyle Precision Pro 72011-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00357599807009), received between Jun 13, 2024 and Feb 17, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Low Readings

  A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER OBTAINED A GLUCOSE READING OF 20 MG/DL ON THE ADC DEVICE COMPARED TO A GLUCOSE READING OF 300 MG/DL OBTAINED ON ANOTHER ADC METER. THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE D ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372135 ↗
• MalfunctionDec 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL REPORTED A HIGH READING FROM AN ABBOTT DIABETES CARE BLOOD GLUCOSE HOSPITAL METER. THE HEALTHCARE PROFESSIONAL REPORTED A HIGH BLOOD GLUCOSE READING OF 500 MG/DL COMPARED TO AN ABBOTT DIABETES CARE BLOOD GLUCOSE METER READING OF 79 MG/DL. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FALL IN THE D ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932994 ↗
• MalfunctionDec 19, 2025Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTS A BATTERY OF A HOSPITAL ABBOTT DIABETES CARE DEVICE "EXPLODED." NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO REPORT OF FIRE, SMOKE, OR SHOCK. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854512 ↗
• InjuryApr 7, 2025Low Readings; Low Readings

  A LOW READING ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. A HEALTHCARE PROFESSIONAL REPORTED UNSPECIFIED INCORRECT READINGS RECEIVED ON THE ADC DEVICE. ON (B)(6) 2025 AT 09:55AM, THE CUSTOMER HAD A READING OF 40 MG/DL USING A LABORATORY ANALYZER. AT 10:59AM AND 11:02AM, THEY OBTAINED A BLOOD GLUCOSE READING OF LESS THAN 20 MG/DL USING THE ADC METER. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS, BUT WAS TREATED WITH 5% DEXTROSE ADMINISTERED INTRAVENOUSLY BY A HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 21787027 ↗
• MalfunctionMar 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN HOSPITAL ABBOTT DIABETES CARE BLOOD GLUCOSE DEVICE. THE HEALTH CARE PROFESSIONAL REPORTED A BLOOD GLUCOSE RESULTS OF 400 MG/DL COMPARED TO A READING OF 125 MG/DL RESPECTIVELY OBTAINED ON AN ABBOTT DIABETES CARE BLOOD GLUCOSE DEVIE AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540233 ↗
• MalfunctionJun 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL REPORTED A HIGH READING FROM AN ABBOTT DIABETES CARE BLOOD GLUCOSE HOSPITAL METER. THE HEALTHCARE PROFESSIONAL REPORTED A HIGH BLOOD GLUCOSE READING OF 220 MG/DL COMPARED TO AN ABBOTT DIABETES CARE BLOOD GLUCOSE METER READING OF 90 MG/DL. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FALL IN THE C ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532754 ↗