FreeStyle Precision ProRecalls & reported problems across all models
Abbott Diabetes Care Inc · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 4 models of FreeStyle Precision Pro by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2017 and Mar 14, 2026 — classified as 3 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (14 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 FreeStyle Precision Pro problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings14
- High Readings2
- Low Readings2
- Product Quality Problem2
- Break1
- Moisture Damage1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient5
- Hypoglycemia3
- Hyperglycemia2
- Insufficient Information1
- No Consequences Or Impact To Patient1
FreeStyle Precision Pro models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FreeStyle Precision Pro 71284SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER14 reports
- FreeStyle Precision Pro 72011-01Calculator/data processing module, for clinical use6 reports
- FreeStyle Precision Pro 71412-70Glucose dehydrogenase, glucose1 report
- FreeStyle Precision Pro 72008-01System, test, blood glucose, over the counter1 report
Recent FreeStyle Precision Pro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2026High Readings
A HEALTH CARE PROFESSIONAL REPORTED ERRONEOUS GLUCOSE RESULTS FROM A HOSPITAL ABBOTT DIABETES CARE DEVICE. THE HEALTH CARE PROFESSIONAL REPORTED A BLOOD GLUCOSE RESULTS OF 501 MG/DL COMPARED TO A READING OF 156 MG/DL RESPECTIVELY OBTAINED FROM A BLOOD GLUCOSE LAB AND THE RESULTS, 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 24600361 ↗MalfunctionFeb 17, 2026Low Readings
A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER OBTAINED A GLUCOSE READING OF 20 MG/DL ON THE ADC DEVICE COMPARED TO A GLUCOSE READING OF 300 MG/DL OBTAINED ON ANOTHER ADC METER. THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE D 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 24372135 ↗MalfunctionDec 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTHCARE PROFESSIONAL REPORTED A HIGH READING FROM AN ABBOTT DIABETES CARE BLOOD GLUCOSE HOSPITAL METER. THE HEALTHCARE PROFESSIONAL REPORTED A HIGH BLOOD GLUCOSE READING OF 500 MG/DL COMPARED TO AN ABBOTT DIABETES CARE BLOOD GLUCOSE METER READING OF 79 MG/DL. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FALL IN THE D 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 23932994 ↗MalfunctionDec 19, 2025Product Quality Problem; Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTS A BATTERY OF A HOSPITAL ABBOTT DIABETES CARE DEVICE "EXPLODED." NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO REPORT OF FIRE, SMOKE, 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 23854512 ↗MalfunctionSep 5, 2025Non Reproducible Results; Non Reproducible Results
A HEALTH CARE PROFESSIONAL REPORTED ERRATIC READINGS ON AN ABBOTT DIABETES CARE DEVICE. CUSTOMER REPORTED RECEIVING READINGS OF 23 MG/DL AND 119 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 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 22980923 ↗InjuryApr 7, 2025Low Readings; Low Readings
A LOW READING ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. A HEALTHCARE PROFESSIONAL REPORTED UNSPECIFIED INCORRECT READINGS RECEIVED ON THE ADC DEVICE. ON (B)(6) 2025 AT 09:55AM, THE CUSTOMER HAD A READING OF 40 MG/DL USING A LABORATORY ANALYZER. AT 10:59AM AND 11:02AM, THEY OBTAINED A BLOOD GLUCOSE READING OF LESS THAN 20 MG/DL USING THE ADC METER. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS, BUT WAS TREATED WITH 5% DEXTROSE ADMINISTERED INTRAVENOUSLY BY A HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: Hypoglycemia
MAUDE report 21787027 ↗MalfunctionMar 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTH CARE PROFESSIONAL REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN HOSPITAL ABBOTT DIABETES CARE BLOOD GLUCOSE DEVICE. THE HEALTH CARE PROFESSIONAL REPORTED A BLOOD GLUCOSE RESULTS OF 400 MG/DL COMPARED TO A READING OF 125 MG/DL RESPECTIVELY OBTAINED ON AN ABBOTT DIABETES CARE BLOOD GLUCOSE DEVIE AND THE RESULTS, 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 21540233 ↗MalfunctionJun 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTHCARE PROFESSIONAL REPORTED A HIGH READING FROM AN ABBOTT DIABETES CARE BLOOD GLUCOSE HOSPITAL METER. THE HEALTHCARE PROFESSIONAL REPORTED A HIGH BLOOD GLUCOSE READING OF 220 MG/DL COMPARED TO AN ABBOTT DIABETES CARE BLOOD GLUCOSE METER READING OF 90 MG/DL. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FALL IN 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 19532754 ↗MalfunctionNov 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTH CARE PROFESSIONAL REPORTED A PATIENT RECEIVED HIGH READINGS FROM THEIR ADC HOSPITAL DEVICE. THE HEALTH CARE PROFESSIONAL REPORTED HIGH READINGS OF 134 MG/DL AND 134 MG/DL WHICH WERE HIGHER THAN LAB READING OF 34 MG/DL AND 39 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "D" 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: Hypoglycemia
MAUDE report 15744489 ↗MalfunctionDec 21, 2021Incorrect, 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 13052394 ↗InjuryJun 29, 2021Product Quality Problem; Product Quality Problem
ABBOTT DIABETES CARE RECEIVED A MEDWATCH REPORT WHICH CONTAINED THE FOLLOWING INFORMATION: A HEALTHCARE PROFESSIONAL REPORTED THAT "THE BLOOD GLUCOSE TEST STRIP ARE READING WET/DAMAGE". NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF ANY MEDICAL EVENT OR THIRD-PARTY MEDICAL INTERVENTION. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12084415 ↗MalfunctionMay 18, 2021Break; Moisture Damage
THE BLOOD GLUCOSE TEST STRIPS ARE READING WET/DAMAGED.
Patient problems: Insufficient Information
MAUDE report 11841033 ↗MalfunctionOct 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTH CARE PROFESSIONAL REPORTED A HIGH READING FROM AN HOSPITAL ADC BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED A HIGH READING OF 234 MG/DL WHICH WAS HIGHER THAN A LAB READING OF 104 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. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: Hyperglycemia
MAUDE report 10712161 ↗MalfunctionSep 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTH CARE PROFESSIONAL REPORTED ERRATIC READINGS FROM AN ADC HOSPITAL BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED READINGS OF 500 MG/DL AND 29 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "D" 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 10573911 ↗MalfunctionMar 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A HEALTH CARE PROFESSIONAL REPORTED A HIGH READING FROM AN ADC HOSPITAL BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED A HIGH READING OF 157 MG/DL WHICH WAS HIGHER THAN A LAB READING OF 61 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. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9866007 ↗
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.
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