FreeStyle Libre 2 71953 (UDI 00357599803001)Recalls & reported problems
Abbott Diabetes Care Inc · FreeStyle Libre 2 Flash Glucose Monitoring System Reader · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This FreeStyle Libre 2 reader displays glucose readings from the sensor. Its 3,084 adverse event reports often describe product quality problems, unexpected alarms and readers that fail to power up. The reports include 1 death and 434 injuries. Two open recalls name this device: one from July 2023 over an incompatible sensor message, and one from February 2023 over lithium-ion batteries that may swell or overheat. Reports rose to 490 over the last year, up from 103 the year before.
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
- 3,286
- Deaths reported
- 1
- Injuries reported
- 434
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 3,286 adverse event reports that list this exact device (DI 00357599803001), received between Oct 28, 2020 and Sep 28, 2026 — classified as 1 death, 434 injuries, 2,851 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (2,352 reports).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- Jul 12, 2023Open, Classified
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results
Z-2414-2023 · Root cause: Software Design Change · FDA record ↗
- Feb 13, 2023Open, Classified
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
Z-1275-2023 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Product Quality Problem2,352
- Device Alarm System519
- Failure to Power Up182
- Unable to Obtain Readings171
- Device Displays Incorrect Message67
- Premature Discharge of Battery55
- High Readings18
- Incorrect, Inadequate or Imprecise Result or Readings15
Patient problems
- No Clinical Signs, Symptoms or Conditions2,851
- Loss of consciousness202
- Hypoglycemia173
- Hyperglycemia127
- Convulsion/Seizure57
- Dizziness55
- Insufficient Information42
- Diaphoresis34
Recent adverse event reports
The 25 most recent of 3,286 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, 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 50922282 ↗InjurySep 23, 2026Device Alarm System
A customer reported an unexpected low glucose alarm with the Abbott Diabetes Care (ADC) device. As a result, the customer experienced symptoms described as a lack of sleep and nausea. Due to the continuous unexpected low glucose alarms, the customer self-treated by consuming candy. There was no report of death or permanent impairment associated with this event.
Patient problems: Hypoglycemia; Nausea
MAUDE report 50871370 ↗MalfunctionSep 23, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864491 ↗MalfunctionSep 22, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862830 ↗MalfunctionSep 22, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860493 ↗MalfunctionSep 22, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, 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 50857636 ↗MalfunctionSep 21, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848808 ↗MalfunctionSep 21, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848467 ↗MalfunctionSep 21, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847127 ↗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 ADC meter results of 176 mg/dL compared to glucose values of 90 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. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816874 ↗MalfunctionSep 18, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50815439 ↗MalfunctionSep 18, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50814703 ↗MalfunctionSep 18, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50814318 ↗MalfunctionSep 18, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813941 ↗MalfunctionSep 18, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, 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 50812907 ↗MalfunctionSep 17, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812190 ↗MalfunctionSep 17, 2026Device Alarm System
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809119 ↗MalfunctionSep 17, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807276 ↗MalfunctionSep 17, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, 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 50804940 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803512 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803441 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802816 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802372 ↗MalfunctionSep 17, 2026Product Quality Problem
A customer reported their ADC device is too hot to hold. There was no report of fire, smoke, explosion, 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 50801488 ↗MalfunctionSep 17, 2026Device Alarm System
A customer reported an unexpected high/low glucose alarm with the ADC device, in use with the application. There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue. There was no report of death, serious injury, or mistreatment associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801433 ↗
Other System, test, blood glucose, over the counter devices
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- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Libre 2 71952Abbott Diabetes Care Inc · System, test, blood glucose, over the counter1 recall324 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.