ReliOn Ultima 70121Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00681131060301), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Calibration Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K083223); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2018Device Displays Incorrect Message; Calibration Problem; Device Displays Incorrect Message; Calibration Problem

  A CALLER, CALLING ON BEHALF OF A CUSTOMER, REPORTED THE CUSTOMER RECEIVED MULTIPLE ERROR MESSAGES FROM HIS ADC BLOOD GLUCOSE METER, AND A CALIBRATION ISSUE, WHICH PREVENTED A READING FROM BEING DISPLAYED. CALLER FURTHER REPORTED THAT ON (B)(6) 2018 CUSTOMER WAS SHOWING SIGNS OF ¿MENTAL STATUS CONFUSION AND WEAKNESS¿ SO HE WAS TAKEN TO A HOSPITAL. AT THE HOSPITAL A READING OF 500 MG/DL WAS RECEIVED. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND A CEREBRAL VASCULAR ACCIDENT AND TREATED WITH AN UNSPECIFIED INTRAVENOUS INFUSION AND INSULIN VIA INJECTION. CUSTOMER WAS HOSPITALIZED AND DISCHARGED ON (B)(6) 2018. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 7987374 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083223. One submission often covers many models, so check the product and lot details in each record.

• Z-1000-2011 · Dec 22, 2010 · Terminated
  Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;