OneTouch Ultramini 021-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00353885000482), received between Dec 22, 2017 and Dec 22, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Component Missing” (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.

• InjuryDec 22, 2017Component Missing; Component Missing

  ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT A LANCING DEVICE WAS MISSING FROM HER KIT. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ISSUE WITH THE LANCING DEVICE OCCURRED ON (B)(6) 2017 AT 3.44 PM. HE REPORTED THAT HE MANAGES HIS DIABETES WITH INSULIN(SELF-ADJUSTER) AND HE ADMINISTERED HIS NORMAL AMOUNT OF MEDICATION (NOVOLOG 14 UNITS). THE PATIENT ALLEGED THAT ON THE DAY THE LANCING DEVICE ISSUE BEGAN HE DEVELOPED SYMPTOM OF ¿SWEATY¿. NO TREATMENT WAS REQUIRED FOR THE ALLEGED SYMPTOM. DURING TROUBLESHOOTING THE CSR NOTED THAT THE LANCING DEVICE WAS MISSING FROM THE PACKAGE, AND THE CLOSURE SEAL ON THE PACKAGING WAS INTACT, PRIOR TO OPENING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

  Patient problems: Sweating

  MAUDE report 7141471 ↗