Precision Xceed Pro 70932Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00093815709329), received between May 5, 2017 and Sep 18, 2023 — classified as 24 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, 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 ↗
• 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 ↗
• 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 7031977 ↗
• 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 7031976 ↗
• 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 7031974 ↗
• MalfunctionNov 14, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A HIGH READING ON A HOSPITAL ADC BLOOD GLUCOSE METER. A HEALTH CARE PROFESSIONAL REPORTED A READING OF 404 MG/DL WHICH WAS LOWER THAN LAB READING OF 9 MG/DL. THE RESULTS FELL INTO THE "E" 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 7030012 ↗
• MalfunctionSep 19, 2017High Readings; High Readings

  A HEALTHCARE PROFESSIONAL REPORTED RECEIVING INACCURATELY HIGH READINGS ON THE ADC BLOOD GLUCOSE METER. HEALTH PROFESSIONAL REPORTED RECEIVING METER READINGS OF 227 MG/DL AND 278 MG/DL COMPARED TO A LAB RESULT OF 93 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. THE REPORTED READINGS WERE OBTAINED FROM A PATIENT EXPERIENCING MEDICAL ISSUES UNRELATED TO DIABETES. THE REPORTED ISSUE DID NOT CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR MISTREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877729 ↗
• MalfunctionSep 19, 2017High Readings; High Readings

  A HEALTHCARE PROFESSIONAL REPORTED RECEIVING AN INACCURATELY HIGH READING ON THE ADC BLOOD GLUCOSE METER. HEALTH PROFESSIONAL REPORTED RECEIVING A METER READING OF 285 MG/DL COMPARED TO A LAB RESULT OF 93 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. THE REPORTED ADC READING WAS OBTAINED FROM A PATIENT EXPERIENCING MEDICAL ISSUES UNRELATED TO DIABETES. THE REPORTED ISSUE DID NOT CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR MISTREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6877686 ↗
• MalfunctionSep 19, 2017High Readings; High Readings

  A HEALTHCARE PROFESSIONAL REPORTED RECEIVING AN INACCURATELY HIGH READING ON THE ADC BLOOD GLUCOSE METER. HEALTH PROFESSIONAL REPORTED RECEIVING A METER READING OF ">500 MG/DL" COMPARED TO A LAB RESULT OF 169 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. THE REPORTED ADC READING WAS OBTAINED FROM A PATIENT EXPERIENCING MEDICAL ISSUES UNRELATED TO DIABETES. THE REPORTED ISSUE DID NOT CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR MISTREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6877685 ↗
• MalfunctionMay 5, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  HEALTH PROFESSIONAL REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 45 MG/DL AND 454 MG/DL WERE PLOTTED ON A PARKES ERROR GRID AND 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 6549807 ↗
• MalfunctionMay 5, 2017High Readings; High Readings

  A HEALTH CARE PROFESSIONAL REPORTED RECEIVING A HIGH ADC READING OF 87 MG/DL AS COMPARED TO A LABORATORY REFERENCE READING OF 21 MG/DL OBTAINED 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 6549806 ↗
• MalfunctionMay 5, 2017High Readings; High Readings

  HEALTH PROFESSIONAL REPORTED RECEIVING AN INACCURATELY HIGH READING ON THEIR ADC BLOOD GLUCOSE METER. HEALTH PROFESSIONAL REPORTED RECEIVING A METER READING OF 75 MG/DL COMPARED TO A LAB RESULT OF 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: No Known Impact Or Consequence To Patient

  MAUDE report 6549733 ↗