Precision XtraRecalls & reported problems across all models
Abbott Diabetes Care Inc · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 391
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 10 models of Precision Xtra by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 391 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2017 and Aug 22, 2026 — classified as 18 injuries, 373 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (361 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Precision Xtra problems
Device problems
- Failure to Power Up361
- Incorrect, Inadequate or Imprecise Result or Readings14
- High Readings6
- No Device Output3
- Premature Discharge of Battery2
- Product Quality Problem2
- Battery Problem1
- Crack1
Patient problems
- No Known Impact Or Consequence To Patient227
- No Clinical Signs, Symptoms or Conditions139
- Hypoglycemia10
- Loss of consciousness6
- Dizziness5
- Hyperglycemia5
- No Consequences Or Impact To Patient3
- Insufficient Information2
Precision Xtra models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Precision Xtra 99837SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER207 reports
- Precision Xtra 98814Glucose dehydrogenase, glucose153 reports
- Precision Xtra 71502SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER12 reports
- Precision Xtra 99694Glucose dehydrogenase, glucose6 reports
- Precision Xtra 99695SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER4 reports
- Precision Xtra 99728SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3 reports
- Precision Xtra 99877Glucose dehydrogenase, glucose3 reports
- Precision Xtra 70745NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)1 report
- Precision Xtra 80050Glucose dehydrogenase, glucose1 report
- Precision Xtra 99838Glucose dehydrogenase, glucose1 report
Recent Precision Xtra adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 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 50387172 ↗MalfunctionApr 1, 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 24753138 ↗MalfunctionFeb 26, 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 24454514 ↗MalfunctionFeb 25, 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 24440265 ↗MalfunctionFeb 2, 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 24234667 ↗MalfunctionJan 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 23971539 ↗MalfunctionJun 3, 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 22132466 ↗MalfunctionMay 27, 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 22087353 ↗MalfunctionNov 27, 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 20794448 ↗MalfunctionNov 18, 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 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 20706093 ↗MalfunctionSep 17, 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 20234975 ↗MalfunctionSep 2, 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 20116699 ↗MalfunctionJul 10, 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 19709503 ↗MalfunctionApr 26, 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 19189565 ↗MalfunctionApr 23, 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 19161753 ↗
Other Abbott Diabetes Care Inc products
- FreeStyle Libre 314 models · 69,860 reports · 6 recalls
- FreeStyle Libre 3 Plus5 models · 52,808 reports · 2 recalls
- FreeStyle Libre 212 models · 30,420 reports · 2 recalls
- FreeStyle Libre 14 day5 models · 16,749 reports · 1 recall
- FreeStyle Lite9 models · 3,388 reports
- FreeStyle Libre 2 Plus4 models · 3,192 reports
- FreeStyle Freedom Lite5 models · 2,436 reports
- FreeStyle Libre7 models · 705 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page