OneTouch Ultra Blue 022-896Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00353885009720), received between Jan 7, 2017 and Jun 17, 2019 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJun 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE EVALUATION: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING; THE REPORTED ISSUE WAS CONFIRMED. THE TEST STRIPS WERE FOUND TO HAVE SCRAP TOP TAPE OVER THE ELECTRODES. ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT ¿SOME¿ OF THE PATIENT¿S ONETOUCH ULTRA TEST STRIPS DIDN'T ¿HAVE BLACK AND WHITE STRIPS ON THE STRIP, ONLY BLUE LABEL¿. THIS COMPLAINT WAS INITIALLY RULED OUR BECAUSE INFORMATION OBTAINED DURING THE INITIAL CALL DID NOT REASONABLY SUGGEST A MALFUNCTION HAD OCCURRED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8702771 ↗
• InjuryJan 7, 2017Bent; Bent

  ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT HIS ONETOUCH ULTRA TEST STRIPS WERE BENT AND PEELING. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ISSUE OCCURRED ¿2 TO 3 WEEKS¿ PRIOR TO CONTACTING LFS. THE PATIENT MANAGES HIS DIABETES BY SELF-ADJUSTING HIS INSULIN DOSES AND INCREASED THE DOSE OF HIS HUMALOG INSULIN BY 1-2 UNITS DURING THE DAY AND HIS LANTUS INSULIN BY 2 UNITS AT NIGHT IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ¿30 MINUTES¿ AFTER THE ALLEGED ISSUE OCCURRED HE DEVELOPED SYMPTOMS OF ¿HEADACHES, BLURRED VISION, BOTHER WITH HIS LEGS AND CHEST PAINS¿ AND STATED THAT ¿A COUPLE OF WEEKS¿ PRIOR TO CONTACTING LFS HE VISITED HIS DOCTOR, WHO ¿REFERRED HIM TO ANOTHER DOCTOR¿. DURING THE CALL THE CCA NOTED THAT MORE THAN ONE STRIP IN THE VIAL WAS AFFECTED AND THEY WERE BENT AND PEELING PRIOR TO INSERTING THE STRIP INTO THE METER. THE PRODUCT WAS REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGE

  Patient problems: Blurred Vision; Chest Pain; Headache

  MAUDE report 6231579 ↗