OneTouch Ultra Blue 020-994Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00353885994255), received between Sep 19, 2017 and Sep 27, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 16, 2021Class IIOpen, Classified

   Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

   Z-1938-2021 · Root cause: Environmental control · Recall details · FDA record ↗

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.

• InjurySep 27, 2017Peeled/Delaminated; Peeled/Delaminated

  ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA TEST STRIPS WERE PEELING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT SHE FIRST NOTICED THAT THE TEST STRIPS WERE PEELING AT 7:00PM ON (B)(6) 2017; THE ALLEGED ISSUE OCCURRED WHEN THE TEST STRIPS WAS INSERTED INTO THE TEST STRIP PORT OF THE METER. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISE. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. SHE REPORTED THAT ONE DAY AFTER THE ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF ¿HEADACHE, SWEATING AND TIRED¿. SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS ABOVE AND BEYOND HER USUAL DIABETES CARE AND MANAGEMENT ROUTINE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING STEPS. THE ALLEGED ISSUE OCCURRED AFTER INSERTING THE STRIP INTO THE METER. THE CCA WALKED THE PATIENT THROUGH INSERTING A NEW TEST STRIP AND THE ISSUE WAS RESOLVED. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED

  Patient problems: Fatigue; Headache; Sweating

  MAUDE report 6896588 ↗
• InjurySep 19, 2017Peeled/Delaminated; Peeled/Delaminated

  ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA TEST STRIPS WERE PEELING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT SHE FIRST NOTICED THAT THE TEST STRIPS WERE PEELING AT 7:00PM ON (B)(6) 2017; THE ALLEGED ISSUE OCCURRED WHEN THE TEST STRIPS WAS INSERTED INTO THE TEST STRIP PORT OF THE METER. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISE. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. SHE REPORTED THAT ONE DAY AFTER THE ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF ¿HEADACHE, SWEATING AND TIRED¿. SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS ABOVE AND BEYOND HER USUAL DIABETES CARE AND MANAGEMENT ROUTINE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING STEPS. THE ALLEGED ISSUE OCCURRED AFTER INSERTING THE STRIP INTO THE METER. THE CCA WALKED THE PATIENT THROUGH INSERTING A NEW TEST STRIP AND THE ISSUE WAS RESOLVED. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED

  Patient problems: Fatigue; Headache; Sweating

  MAUDE report 6875034 ↗