OneTouch Ultramini 021-911Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00353885002677), received between Sep 13, 2017 and Sep 13, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (1 report).

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 18, 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.

• InjurySep 13, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO A HOSPITAL METER (BRAND NOT REPORTED). THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED INACCURACY FIRST BEGAN. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿299 MG/DL¿ WITH THE SUBJECT METER AND ¿199 MG/DL¿ ON THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. THE PATIENT MANAGES HER DIABETES WITH SELF-ADJUSTED INSULIN (HUMALOG) AND SHE ADVISED THAT IN RESPONSE TO THE ALLEGED INACCURACY ISSUE, SHE INCREASED THE DOSE OF HER INSULIN BASED ON A SLIDING SCALE (DOSE NOT SPECIFIED). THE PATIENT REPORTED THAT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF FEELING ¿FATIGUE, SHAKINESS AND BLURRED VISION¿. THE PATIENT STATED THAT SHE WAS ADMITTED TO HO

  Patient problems: Blurred Vision; Fatigue; Shaking/Tremors

  MAUDE report 6860903 ↗