Precision Xtra 99877Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00093815998778), received between Aug 2, 2018 and Nov 30, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “High Readings” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2021High Readings; High Readings

  A CALLER REPORTED A HIGH READING ISSUE WITH THE ADC BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED UNSPECIFIED HIGH READING, BUT SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS UNRESPONSIVE. THE CUSTOMER WAS TAKEN TO THE HOSPITAL AND HEALTHCARE METER RESULTS OF 72 MG/DL AND 79 MG/DL WERE OBTAINED AS COMPARED TO ADC METER RESULT OF 172 MG/DL. THE CUSTOMER WAS DIAGNOSED WITH HYPOGLCYEMIA, AND PROVIDED UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT. THE RESULTS OF ADC METER AGAINST HEALTHCARE METER, WHEN PLOTTED ON A PARKES ERROR GRID FALL INTO THE "C" ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 12903724 ↗
• MalfunctionAug 6, 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 346 MG/DL, 157 MG/DL AND 75 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 7751919 ↗
• InjuryAug 2, 2018High Readings; High Readings

  CUSTOMER REPORTED THAT ON (B)(6) 2018 AT 3:43 P.M., SHE OBTAINED A READING OF 192 MG/DL ON HER ADC METER THAT SHE FELT WAS HIGH. CUSTOMER FURTHER REPORTED SHE "WASN'T FEELING WELL" AND AFTER LEAVING THE DOCTOR'S CLINIC, SHE WALKED OUT OF THE BUILDING AND EXPERIENCED A LOSS OF CONSCIOUSNESS. PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL WITHIN 5-10 MINUTES, A READING OF 39 MG/DL WAS OBTAINED ON THEIR DEVICE. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS "TO BRING (HER) SUGAR UP" AND A PEANUT BUTTER AND JELLY SANDWICH. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 7744668 ↗

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-0997-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care, Optium Blood Glucose Test Strips;
• 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;