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FreeStyle Freedom Lite 71499Recalls & reported problems

Abbott Diabetes Care Inc · FreeStyle Freedom Lite Blood Glucose Monitoring System · Class 2

Quick summary

This Abbott FreeStyle Freedom Lite blood glucose meter has 207 adverse event reports: no deaths and 7 injuries. Most reports describe the meter not turning on, and a few describe a low reading that differed sharply from another meter. Some reports also list patient symptoms such as high blood sugar or loss of consciousness. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
208
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00699073714992), received between Apr 21, 2017 and Sep 30, 2026 — classified as 7 injuries, 201 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (198 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.

Reports received per month

Nov 2023: 7 reportsDec 2023: 0 reportsJan 2024: 4 reportsFeb 2024: 1 reportsMar 2024: 2 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 3 reportsAug 2024: 3 reportsSep 2024: 0 reportsOct 2024: 4 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 2 reportsMay 2025: 2 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 3 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Power Up198
  • Incorrect, Inadequate or Imprecise Result or Readings5
  • No Device Output2
  • Device Displays Incorrect Message1
  • Display or Visual Feedback Problem1
  • Premature Discharge of Battery1
  • Unable to Obtain Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions121
  • No Known Impact Or Consequence To Patient77
  • Hyperglycemia4
  • Loss of consciousness4
  • Confusion/ Disorientation1
  • Convulsion/Seizure1
  • Diaphoresis1
  • Dizziness1

Recent adverse event reports

The 25 most recent of 208 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Failure to Power Up

    The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942996 ↗
  • MalfunctionAug 28, 2026Failure to Power Up

    The reporter contacted Abbott Diabetes Care, alleging the meter will not turn on. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no report of death, serious injury, or mistreatment associated with this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50493394 ↗
  • MalfunctionMay 6, 2026Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25091754 ↗
  • MalfunctionApr 16, 2026Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24903159 ↗
  • MalfunctionMar 18, 2026Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24634737 ↗
  • MalfunctionFeb 16, 2026Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24344164 ↗
  • MalfunctionFeb 11, 2026Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24314476 ↗
  • MalfunctionFeb 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

    CUSTOMER REPORTED RECEIVING A LOW READING FROM THEIR ABBOTT DIABETES CARE DEVICE. CUSTOMER REPORTED A LOW READING OF 26 MG/DL WHICH WAS LOWER THAN A METER IN READING OF 145 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. THE LENGTH OF SENSOR WEAR WAS UNKNOWN. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24258302 ↗
  • MalfunctionJan 13, 2026Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24053252 ↗
  • MalfunctionSep 2, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22935908 ↗
  • MalfunctionJul 11, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22477756 ↗
  • MalfunctionMay 30, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22112382 ↗
  • MalfunctionMay 5, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21959075 ↗
  • MalfunctionApr 30, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21935379 ↗
  • MalfunctionApr 11, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21823917 ↗
  • MalfunctionMar 21, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21664442 ↗
  • MalfunctionMar 20, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21649986 ↗
  • MalfunctionJan 28, 2025Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21253174 ↗
  • MalfunctionDec 6, 2024Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20862108 ↗
  • MalfunctionNov 8, 2024Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20640231 ↗
  • MalfunctionOct 24, 2024Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20520650 ↗
  • MalfunctionOct 4, 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 THE C ZONE. THE LENGTH OF SENSOR WEAR WAS 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 20370810 ↗
  • MalfunctionOct 4, 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 THE C ZONE. THE LENGTH OF SENSOR WEAR WAS 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 20370370 ↗
  • MalfunctionOct 4, 2024Failure to Power Up; Failure to Power Up

    THE REPORTER CONTACTED ABBOTT DIABETES CARE, ALLEGING THE METER WILL NOT TURN ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20369097 ↗
  • InjuryAug 23, 2024Unable to Obtain Readings; Device Displays Incorrect Message; Unable to Obtain Readings; Device Displays Incorrect Message

    AN ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER RECEIVED AN UNSPECIFIED ERROR MESSAGE ON THEIR METER DISPLAY AND WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER EXPERIENCED A SEIZURE AND A LOSS OF CONSCIOUSNESS AND WAS ABLE TO SELF-TREAT WITH METFORMIN WHICH WAS PROVIDED TO THEM BY A HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Patient problems: Convulsion/Seizure; Hyperglycemia; Loss of consciousness

    MAUDE report 20050318 ↗

Other SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.