Precision Xtra 99838Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00093815998389), received between Aug 8, 2018 and Aug 8, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Low Readings” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2018Low Readings; Low Readings

  CUSTOMER'S DAUGHTER REPORTED THAT ON (B)(6) 2018 AT 12:00 P.M., THE CUSTOMER RECEIVED A READING OF 108 MG/DL ON HIS ADC BLOOD GLUCOSE METER WHICH WAS LOWER THAN HE FELT. IT WAS FURTHER REPORTED THE CUSTOMER EXPERIENCED FEELING "SLEEPY AND TIRED" AND WAS SEEN AT A HOSPITAL WHERE A READING OF 302 MG/DL WAS OBTAINED ON THE HOSPITAL METER AT 1:00 P.M. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH "2-3 BAGS" OF INTRAVENOUS FLUIDS "TO LOWER GLUCOSE". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Fatigue; Hyperglycemia

  MAUDE report 7762864 ↗

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-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;
• Z-0996-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; MediSense Optium Blood Glucose Electrodes;