FreeStyle Libre 3 Plus 78769-01Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 3 PLUS Sensor NFRS · Class 2
Quick summary
This Abbott FreeStyle Libre 3 Plus sensor has 296 reports, including 2 injuries and no deaths. Most describe readings that were incorrect or imprecise, and some reports say the sensor readings differed from a comparison glucose meter by clinically significant amounts. Reports rose to 282 in the latest 12 months from 14 in the 12 months before. 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
- 367
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 367 adverse event reports that list this exact device (DI 30357599843008), received between Mar 10, 2025 and Sep 21, 2026 — classified as 2 injuries, 365 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (304 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 Readings304
- Low Readings47
- Device Alarm System10
- Detachment of Device or Device Component4
- Delivered as Unsterile Product2
Patient problems
- No Clinical Signs, Symptoms or Conditions361
- Device Embedded In Tissue or Plaque4
- Fever1
- Hyperglycemia1
- Insufficient Information1
- Loss of consciousness1
- Shaking/Tremors1
Recent adverse event reports
The 25 most recent of 367 reports, in the reporter's own words as published by the FDA.
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 62 mg/dL, 50 mg/dL compared to glucose values of 109 mg/dL, 292 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 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 50841315 ↗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 298 mg/dL compared to glucose values of 150 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 6 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 50835877 ↗MalfunctionSep 20, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834783 ↗MalfunctionSep 18, 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 283 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 50814241 ↗MalfunctionSep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786779 ↗MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774852 ↗MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774608 ↗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 glucose values of 167 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 is 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 50770656 ↗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 55 mg/dL compared to glucose values of 168 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 50754190 ↗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 50 mg/dL compared to glucose values of 170 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 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 50753703 ↗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 50mg/dL compared to glucose values of 200mg/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 7 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 50751813 ↗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 60 mg/dL, 69 mg/dL compared to glucose values of 170 mg/dL, 155 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 9 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 50749478 ↗MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50731241 ↗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 "[81 mg/dL]" compared to glucose values of "[321 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 is 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 50729871 ↗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 52 mg/dL compared to glucose values of 200 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 50729154 ↗MalfunctionSep 10, 2026Delivered as Unsterile Product
A customer reported that they received an ADC device in a state where the sterile barrier appeared to be compromised. There was no indication that the customer applied the device to their body, and no patient consequences were reported. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712851 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50708202 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50689032 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50688883 ↗MalfunctionSep 9, 2026Delivered as Unsterile Product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50687354 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
A customer reported that an ADC device component detached and remained in skin. There was no indication that the customer required intervention from a healthcare professional to remove the component. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50669346 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
A customer reported that an ADC device component detached and remained in skin. There was no indication that the customer required intervention from a healthcare professional to remove the component. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50668138 ↗MalfunctionSep 8, 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 (b)(6) compared to glucose values of (b)(6) 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 7 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 50662022 ↗MalfunctionSep 8, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50660849 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576430 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.