FreeStyle Precision Pro 71284Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00093815712848), received between Dec 15, 2017 and Nov 7, 2022 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED A PATIENT RECEIVED HIGH READINGS FROM THEIR ADC HOSPITAL DEVICE. THE HEALTH CARE PROFESSIONAL REPORTED HIGH READINGS OF 134 MG/DL AND 134 MG/DL WHICH WERE HIGHER THAN LAB READING OF 34 MG/DL AND 39 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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: Hypoglycemia

  MAUDE report 15744489 ↗
• MalfunctionDec 21, 2021Incorrect, 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 13052394 ↗
• InjuryJun 29, 2021Product Quality Problem; Product Quality Problem

  ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH CONTAINED THE FOLLOWING INFORMATION: A HEALTHCARE PROFESSIONAL REPORTED THAT "THE BLOOD GLUCOSE TEST STRIP ARE READING WET/DAMAGE". NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF ANY MEDICAL EVENT OR THIRD-PARTY MEDICAL INTERVENTION. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084415 ↗
• MalfunctionMay 18, 2021Break; Moisture Damage

  THE BLOOD GLUCOSE TEST STRIPS ARE READING WET/DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 11841033 ↗
• MalfunctionOct 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED A HIGH READING FROM AN HOSPITAL ADC BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED A HIGH READING OF 234 MG/DL WHICH WAS HIGHER THAN A LAB READING OF 104 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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: Hyperglycemia

  MAUDE report 10712161 ↗
• MalfunctionSep 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED ERRATIC READINGS FROM AN ADC HOSPITAL BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED READINGS OF 500 MG/DL AND 29 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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 10573911 ↗
• MalfunctionMar 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED A HIGH READING FROM AN ADC HOSPITAL BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED A HIGH READING OF 157 MG/DL WHICH WAS HIGHER THAN A LAB READING OF 61 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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 Known Impact Or Consequence To Patient

  MAUDE report 9866007 ↗
• MalfunctionSep 10, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEATH CARE PROFESSIONAL REPORTED A HIGH READING FROM AN ADC HOSPITAL BLOOD GLUCOSE METER. CUSTOMER REPORTED A HIGH READING OF 343 MG/DL WHICH WAS HIGHER THAN A LAB READING OF 129 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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 Known Impact Or Consequence To Patient

  MAUDE report 8983391 ↗
• InjuryApr 4, 2019High Readings; High Readings

  A HEALTHCARE PROFESSIONAL REPORTED RECEIVING HIGH READING ON THE ADC BLOOD GLUCOSE METER. ON (B)(6) 2019 AT 08:39 A.M., A PATIENT'S BLOOD GLUCOSE WAS CHECKED AND A METER READING OF GREATER THAN 400 MG/DL WAS OBTAINED COMPARED TO A READING OF 58 MG/DL OBTAINED ON THE UNSPECIFIED EMS METER AT UNKNOWN TIME. IT WAS FURTHER REPORTED THE PATIENT WAS TREATED WITH ORAL GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 8484239 ↗
• MalfunctionApr 2, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A HIGH READING FROM A HOSPITAL ADC BLOOD GLUCOSE METER. A HEALTH CARE PROFESSIONAL REPORTED A READING OF 400 MG/DL WHICH WAS HIGHER THAN A LAB READING OF 72 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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 Known Impact Or Consequence To Patient

  MAUDE report 8474679 ↗
• MalfunctionFeb 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTHCARE PROFESSIONAL REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 19 MG/DL (DISPLAYED AS A "LO" DISPLAY MESSAGE ON THE REPORTED METER), AND 135 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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 Known Impact Or Consequence To Patient

  MAUDE report 7268630 ↗
• MalfunctionJan 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED ERRATIC READINGS ON AN ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 135 MG/DL AND "LO" (READING OF LESS THAN 19 MG/DL) WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS FELL 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 Consequences Or Impact To Patient

  MAUDE report 7233030 ↗
• MalfunctionJan 31, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH PROFESSIONAL REPORTED RECEIVING ERRATIC READINGS ON AN ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 387 MG/DL, 75 MG/DL AND "LO" (A READING LESS THAN 20 MG/DL) WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS FELL 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 Known Impact Or Consequence To Patient

  MAUDE report 7233018 ↗
• MalfunctionDec 15, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED THAT RECEIVING A HIGH READING ON A HOSPITAL ADC BLOOD GLUCOSE METER. A HEALTH CARE PROFESSIONAL REPORTED A READING OF GREATER THAN 500 MG/DL WHEN COMPARED TO A LABORATORY READING OF 133 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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: Hyperglycemia

  MAUDE report 7123791 ↗