OneTouch Ultramini 021-422Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00353885001311), received between Feb 3, 2017 and Aug 21, 2019 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN UNITED STATES, ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿218 AND 334 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914261 ↗
• InjuryFeb 3, 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 ANOTHER ONETOUCH ULTRAMINI. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT 2 A.M., ON (B)(6) 2017. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿109 MG/DL¿ WITH THE SUBJECT METER AND ¿70 MG/DL¿ WITH THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LFS¿S CRITERIA FOR ACCURACY. THE PATIENT ADVISED THAT SHE DOES NOT TAKE ANY MEDICATION TO MANAGE HER DIABETES AND REPORTED THAT APPROXIMATELY 10 MINUTES PRIOR TO OBTAINING THE ALLEGED INACCURATELY HIGH BLOOD GLUCOSE READING, SHE DEVELOPED SYMPTOMS OF ¿ITCHING, SWEATING AND NAUSEA¿. THE PATIENT ADVISED THAT SHE SELF-TREATED HER SYMPTOMS BY DRINKING 3 OZ., OF ORANGE JUICE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT

  Patient problems: Itching Sensation; Nausea; Sweating

  MAUDE report 6299232 ↗