Precision Xtra 99694Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00093815996941), received between Oct 6, 2017 and Apr 15, 2020 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K051213); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2020Incorrect, 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 400 MG/DL AND 90 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 9963125 ↗
• InjuryJun 27, 2019High Readings; High Readings

  CUSTOMER¿S WIFE REPORTED CUSTOMER RECEIVED UNSPECIFIED READINGS FROM HIS ADC BLOOD GLUCOSE METER THAT WERE BELIEVED TO BE ERRONEOUSLY HIGH. SHE FURTHER REPORTED THAT ON (B)(6)2019 CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED, TREATED HIM WITH AN UNSPECIFIED MEDICATION AND TRANSPORTED HIM TO A HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE CALLER DECLINED TO CONTINUE TROUBLESHOOTING AND DISCONNECTED THE CALL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 8740585 ↗
• InjuryMar 25, 2019No Device Output; No Device Output

  CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO HIS ADC BLOOD GLUCOSE METER TURNING ON WITH BUTTON PRESS BUT NOT WITH INSERTION OF TEST STRIPS. CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2019, HE EXPERIENCED NERVOUSNESS AND DRY MOUTH, AND WENT TO A CLINIC TO GET HIS BLOOD GLUCOSE LEVELS MEASURED BECAUSE HE HAD NO OTHER DEVICE. A READING OF 51 MG/DL WAS OBTAINED ON THE HCP METER, AND THE CUSTOMER WAS GIVEN SOMETHING TO EAT AND DRINK AND WAS TOLD TO REST. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 8449760 ↗
• InjuryAug 24, 2018High Readings; High Readings

  CUSTOMER REPORTED RECEIVING A HIGHER READING THAN A READING FROM A HCP METER AND PROVIDED THE FOLLOWING RESULTS: ADC METER: 228 MG/DL VS HCP METER: 53 MG/DL. CUSTOMER FURTHER REPORTED THAT ON (B)(6) 2018 CUSTOMER RECEIVED THE READING OF 228 MG/DL AND TOOK HIS UNSPECIFIED REGULAR LEVEMIR (INSULIN DETEMIR) DOSE. HE FURTHER NOTED RECEIVING A READING OF 75 MG/DL, BUT IT IS UNKNOWN WHEN THIS READING WAS RECEIVED. A FEW HOURS LATER, HE FELT ¿TIRED AND HIS VISION WAS BLURRY¿ SO HE SELF-PRESENTED TO HIS HEALTHCARE PROVIDER. AT THE HCP OFFICE, A READING OF 53 MG/DL WAS RECEIVED AND HE WAS GIVEN TWO BOXES OF JUICE TO DRINK. A SUBSEQUENT READING OF 83 MG/DL WAS RECEIVED AND NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 7814926 ↗
• InjuryApr 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED HER ADC BLOOD GLUCOSE METER WAS "GIVING FALSE READINGS" AND THAT "BECAUSE OF THE READINGS, (SHE) BEEN AT THE HOSPITAL LAST YEAR". READINGS OF 342 MG/DL AND 261 MG/DL WERE REPORTEDLY OBTAINED ON THE ADC METER BUT IT IS UNKNOWN WHEN THESE READINGS WERE OBTAINED RELATED TO THE REPORTED HOSPITAL VISIT. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER AS SHE DECLINED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Information

  MAUDE report 7419646 ↗
• MalfunctionOct 6, 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. CUSTOMER REPORTED RECEIVING READINGS OF 22 MG/DL AND 118 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 Consequences Or Impact To Patient

  MAUDE report 6925919 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051213. One submission often covers many models, so check the product and lot details in each record.

• Z-0996-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; MediSense Optium Blood Glucose Electrodes;
• Z-0999-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Glucose & Ketone Monitoring System; Precision G3b Smartblue Blood Glucose Test Strips;
• Z-0997-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care, Optium Blood Glucose Test Strips;