Precision Xceed ProRecalls & reported problems across all models

We found 2 models of Precision Xceed Pro by Abbott Diabetes Care Inc in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between May 5, 2017 and Sep 18, 2023 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (19 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

Most reported Precision Xceed Pro problems

Precision Xceed Pro models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Precision Xceed Pro 70932

  NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
  24 reports
• Precision Xceed Pro 70907-03

  Glucose dehydrogenase, glucose
  1 report

Recent Precision Xceed Pro adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED ERRATIC READINGS FROM AN ADC DEVICE. THE HEALTH CARE PROFESSIONAL REPORTED READINGS OF "LO" (BELOW 20 MG/DL) AND 380 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 17765115 ↗
• MalfunctionJan 31, 2023Incorrect, 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 16271263 ↗
• MalfunctionJan 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTS THAT A PATIENT RECEIVED A LOW READING FROM AN ADC HOSPITAL BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED A LOW READING OF 164 MG/DL WHICH WAS LOWER THAN A LAB READING OF 547 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: Insufficient Information

  MAUDE report 13172142 ↗
• MalfunctionMar 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED RECEIVING A LOW READING FROM A HOSPITAL ADC BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED A LOW READING OF 432 MG/DL WHICH WAS LOWER THAN LAB READING OF 642 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL "OUT OF RANGE" 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 11553849 ↗
• MalfunctionDec 2, 2020Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE BATTERY OF AN ADC HOSPITAL BLOOD GLUCOSE METER "EXPLODED" WHILE THE METER WAS SITTING ON THE DOCKING STATION. THE HEALTH CARE PROFESSIONAL FURTHER REPORTED THAT THE METER WAS ALSO "VERY HOT TO THE TOUCH." THERE WAS NO REPORT OF A DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934782 ↗
• MalfunctionJul 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A LOW READING FROM AN ADC HOSPITAL BLOOD GLUCOSE METER. THE HEALTH CARE PROFESSIONAL REPORTED A LOW READING OF 492 MG/DL WHICH WAS LOWER THAN LAB READING OF 678 MG/DL. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL "OUT OF RANGE" 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 10337918 ↗
• MalfunctionSep 27, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED RECEIVING A HIGH READING FROM THEIR ADC HOSPITAL BLOOD GLUCOSE METER. CUSTOMER REPORTED A HIGH READING OF 500 MG/DL WHICH WAS HIGHER THAN A LAB READING OF 121 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 7916430 ↗
• MalfunctionApr 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 362 MG/DL AND A "LO" (READING OF LESS THAN 20 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: Hyperglycemia; Hypoglycemia

  MAUDE report 7419994 ↗
• MalfunctionFeb 28, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A LOWER THAN EXPECTED READING ON A HOSPITAL ADC BLOOD GLUCOSE METER. A HEALTH CARE PROFESSIONAL REPORTED RECEIVING A READING OF LESS THAN 20 MG/DL("LO" DISPLAY MESSAGE INDICATES A READING LESS THAN 20 MG/DL), WHICH WAS LOWER THAN LAB READING OF 135 MG/DL. THE RESULTS FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7305060 ↗
• MalfunctionFeb 28, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER, A HEALTH PROFESSIONAL, REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF LESS THAN 20 MG/DL (A "LO" DISPLAY MESSAGE INDICATES A READING LESS THAN 20 MG/DL) AND 267 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 Known Impact Or Consequence To Patient

  MAUDE report 7303446 ↗
• MalfunctionNov 17, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CALLER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 136 MG/DL AND <20 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS 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 7043678 ↗
• MalfunctionNov 17, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HOSPITAL REPORTED THAT A SPECIFIC ADC TEST STRIP LOT WAS PRODUCING ERRATIC READINGS ACROSS THE HOSPITAL WHEN USED WITH DIFFERENT ADC METERS. IT WAS REPORTED THAT READINGS OF <20 MG/DL AND >500 MG/DL WERE RECEIVED WHEN USING STRIP LOT 4C785H WHEN ATTEMPTING TO OBTAIN PATIENT RESULTS AND THAT MULTIPLE TESTS WERE BEING PERFORMED (WITHIN 10 MINUTES) IN ORDER TO GET A VALID TEST RESULT. THE REPORTER PROVIDED DATA DOCUMENTING READING COMPARISONS TAKEN BETWEEN (B)(6) 2017 THROUGH (B)(6) 2017. MULTIPLE SETS OF READINGS WHEN PLOTTED ON THE 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 Consequences Or Impact To Patient

  MAUDE report 7043454 ↗
• MalfunctionNov 17, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CALLER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 91 MG/DL AND <20 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS 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 7043394 ↗
• MalfunctionNov 17, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CALLER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 233 MG/DL AND <20 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS 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 7043373 ↗
• MalfunctionNov 15, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF "HI" ( >500 MG/DL) AND "LO" ( <20 MG/DL) WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS 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 Known Impact Or Consequence To Patient

  MAUDE report 7031978 ↗

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