FreeStyle Libre 3 Plus 78769 (UDI 00357599843007)Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 3 PLUS Sensor NFRS · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is an Abbott FreeStyle Libre 3 Plus sensor, a small factory-calibrated wearable sensor that reads glucose through the skin without a fingerstick. Most of the 34 reports describe the sensor giving inaccurate or unreliable readings, including some readings far off from other meters, plus a few low readings. Three injuries and no deaths were reported, and 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
- 44
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00357599843007), received between Apr 2, 2025 and Sep 29, 2026 — classified as 3 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (39 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
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings39
- Low Readings4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Hyperglycemia1
- Insufficient Information1
- Purulent Discharge1
- Skin Infection1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 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 69.00 mg/dL compared to readings of 202.00 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 14 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 50932005 ↗MalfunctionSep 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 44.00 mg/dL compared to readings of 407.00 mg/dL respectively obtained on a meter and the results, when plotted on a Parkes Error Grid, fall into the D Zone, showing the difference in values to be clinically significant. The length of sensor wear was 12 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 50911850 ↗MalfunctionSep 21, 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 42.00 mg/dL compared to readings of 145.00 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 50839422 ↗MalfunctionSep 15, 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 353.00 mg/dL compared to readings of 170.00 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 11 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 50772299 ↗MalfunctionSep 15, 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 53 mg/dL compared to readings of 351 mg/dL respectively obtained on a Meter and the results, when plotted on a Parkes Error Grid, fall into the D 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 50770323 ↗MalfunctionSep 15, 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 60 mg/dL compared to readings of 300 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 50769555 ↗MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769076 ↗MalfunctionSep 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 51.00 mg/dL compared to readings of 200.00 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 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 50750671 ↗MalfunctionSep 11, 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 mg/dL compared to readings of 300 mg/dL respectively obtained on a Competitor Brand Meter and the results, when plotted on a Parkes Error Grid, fall into the D Zone, showing the difference in values to be clinically significant. The length of sensor wear was 10 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 50730585 ↗MalfunctionSep 11, 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 57.00 mg/dL compared to readings of 192.00 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 50728320 ↗MalfunctionAug 31, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534079 ↗MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498741 ↗MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498614 ↗MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498601 ↗MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497183 ↗MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50496695 ↗MalfunctionAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490931 ↗MalfunctionAug 27, 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 compared to glucose values of 120.00 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 an unknown number of 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 50486185 ↗MalfunctionAug 27, 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 250.00 mg/dL compared to glucose values of 56.00 mg/dL respectively obtained on the comparison device, when plotted on a Parkes Error Grid, fall into the D Zone, showing the difference in values to be clinically significant. The length of sensor wear was 5 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 50469765 ↗MalfunctionAug 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 350.00 mg/dL compared to readings of 160.00 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 5 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 50276880 ↗MalfunctionAug 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 385 mg/dL compared to readings of 145 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 13 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 50275488 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
An adverse skin reaction was reported with wear of the Abbott Diabetes Care (ADC) device. The customer experienced symptoms described as white pus and self-treated the affected area with triple antibiotic ointment, Betadine, and hydrogen peroxide. There was no report of death or permanent impairment associated with this event.
Patient problems: Purulent Discharge; Skin Infection
MAUDE report 50111958 ↗MalfunctionJul 31, 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 179.00 mg/dL compared to readings of 97.00 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 11 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 50098322 ↗MalfunctionJul 30, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50083469 ↗MalfunctionJul 15, 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 75.00 MG/DL COMPARED TO READINGS OF 192.00 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 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 25825653 ↗
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- Dexcom G7 iOS App SW12300Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 recalls1 death55,219 reports
- Dexcom G7 GSS (161) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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