OneTouch Ultra Blue 022-895Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00353885009713), received between Nov 3, 2017 and Aug 11, 2022 — classified as 6 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 16, 2021Open, 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-1936-2021 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONE TOUCH ULTRA TEST TRIPS WERE ¿MESSED UP¿ AND ¿DIDN T REGISTER¿. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT DID NOT REPORT WHEN THE ALLEGED STRIP ISSUE STARTED. DURING THE FOLLOW-UP CALL THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH AN INSULIN PUMP AND PILLS (TYPE AND DOSE UNSPECIFIED) AND INDICATED THAT SHE DID NOT MADE ANY CHANGES TO HER DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT INFORMED THE AGENT THAT DUE TO THE ALLEGED STRIP ISSUE HER BLOOD SUGAR LEVELS WENT UP TO 500 MG/DL FOR THREE DAYS. DURING THE FOLLOW-UP CALL THE PATIENT CONFIRMED THAT SHE WAS ABLE TO RECEIVE THESE READINGS WITH THE SUBJECT TEST STRIPS. THE PATIENT DID NOT REPORT ANY SYMPTOMS AND DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. THE CCA WAS NOT ABLE TO TROUBLESHOOT THE PROBLEM DURING THE INITIAL CALL AND THE PATIENT WAS UNABLE TO READ THE LOT NUMBER. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECA

  Patient problems: Hyperglycemia

  MAUDE report 15214728 ↗
• InjuryAug 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA TEST TRIPS WERE ¿MESSED UP¿ AND ¿DIDN¿T REGISTER¿. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT DID NOT REPORT WHEN THE ALLEGED STRIP ISSUE STARTED. DURING THE FOLLOW-UP CALL THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH AN INSULIN PUMP AND PILLS (TYPE AND DOSE UNSPECIFIED) AND INDICATED THAT SHE DID NOT MADE ANY CHANGES TO HER DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT INFORMED THE AGENT THAT DUE TO THE ALLEGED STRIP ISSUE HER BLOOD SUGAR LEVELS WENT UP TO 500 MG/DL FOR THREE DAYS. DURING THE FOLLOW-UP CALL THE PATIENT CONFIRMED THAT SHE WAS ABLE TO RECEIVE THESE READINGS WITH THE SUBJECT TEST STRIPS. THE PATIENT DID NOT REPORT ANY SYMPTOMS AND DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. THE CCA WAS NOT ABLE TO TROUBLESHOOT THE PROBLEM DURING THE INITIAL CALL AND THE PATIENT WAS UNABLE TO READ THE LOT NUMBER. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAU

  Patient problems: Hyperglycemia

  MAUDE report 15214727 ↗
• MalfunctionAug 26, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  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 TEST STRIPS APPEAR TO HAVE BEEN CONTAMINATED WITH EXCESS ADHESIVE. COMPLAINTS RELATING TO THE REPORTED PRODUCT(S) WERE EVALUATED. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE PRODUCT(S) DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT OT ULTRA BLUE TEST STRIPS WERE STICKING TOGETHER. THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE DURING CUSTOMER SERVICES TROUBLESHOOTING, THERE WAS NO INDICATION TO REASONABLY SUGGEST THAT THE PRODUCT MALFUNCTIONED AND THERE WAS ALSO NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929425 ↗
• InjuryJul 15, 2019Peeled/Delaminated; Peeled/Delaminated

  ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA BLUE TEST STRIPS WERE PEELING AND STICKING TOGETHER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION OF THE CALL. THE PATIENT REPORTED THAT THE TEST STRIPS WERE PEELING AND STICKING TOGETHER AROUND 9-10 AM ON (B)(6) 2019. THE PATIENT MANAGES HIS DIABETES WITH HUMULIN INSULIN (NO ADJUSTMENTS). HE INDICATED THAT BECAUSE HE WAS UNABLE TO OBTAIN A READING, HE ATE SUGAR TO INCREASE HIS BLOOD GLUCOSE LEVEL ABOUT 30-45 MINUTES LATER. HE REPORTED THAT ABOUT AN HOUR LATER, HE FELT SYMPTOMS OF "NAUSEA, FATIGUE, SHAKING AND ANXIETY". HE DENIED RECEIVING ANY TREATMENT FOR HIS SYMPTOMS ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT ALLEGED ISSUE OCCURRED BEFORE INSERTING THE STRIP INTO THE METER AND MORE THAN ONE TEST STRIP FROM THE VIAL WAS AFFECTED. THE ISSUE REMAINED UNRESOLVED. 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 ISSUE WITH PEELING

  Patient problems: Anxiety; Fatigue; Nausea; Shaking/Tremors

  MAUDE report 8789109 ↗
• InjuryJul 15, 2019Peeled/Delaminated; Peeled/Delaminated

  ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA BLUE TEST STRIPS WERE PEELING AND STICKING TOGETHER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION OF THE CALL. THE PATIENT REPORTED THAT THE TEST STRIPS WERE PEELING AND STICKING TOGETHER AROUND 9-10 AM ON (B)(6) 2019. THE PATIENT MANAGES HIS DIABETES WITH HUMULIN INSULIN (NO ADJUSTMENTS). HE INDICATED THAT BECAUSE HE WAS UNABLE TO OBTAIN A READING, HE ATE SUGAR TO INCREASE HIS BLOOD GLUCOSE LEVEL ABOUT 30-45 MINUTES LATER. HE REPORTED THAT ABOUT AN HOUR LATER, HE FELT SYMPTOMS OF ¿NAUSEA, FATIGUE, SHAKING AND ANXIETY¿. HE DENIED RECEIVING ANY TREATMENT FOR HIS SYMPTOMS ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT ALLEGED ISSUE OCCURRED BEFORE INSERTING THE STRIP INTO THE METER AND MORE THAN ONE TEST STRIP FROM THE VIAL WAS AFFECTED. THE ISSUE REMAINED UNRESOLVED. 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 ISSUE WITH PEELING

  Patient problems: Fatigue; Nausea; Shaking/Tremors

  MAUDE report 8788399 ↗
• InjuryJan 26, 2018Defective Component; Defective Component

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING AN ISSUE WITH HER ONETOUCH ULTRA TEST STRIP VIAL. THE PATIENT CLAIMED THAT THE VIAL INSIDE A SEALED CONTAINER WAS OPEN. THE COMPLAINT WAS CLASSIFIED BASED ON FURTHER INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING SINCE THE PATIENT WAS UNABLE TO BE CONTACTED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT SHE BECAME AWARE OF THE ALLEGED OPEN VIAL ON (B)(6) 2018 AT 8:00 AM. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (METFORMIN) AND INSULIN (HUMULIN). THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN WHEN SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. DURING THE CALL, THE PATIENT REPORTED DEVELOPING ¿LOW BLOOD SUGAR¿ AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED SHE PROCEEDED TO THE URGENT CARE CLINIC ON (B)(6) 2018 AT 10:00 AM WHERE HER BLOOD GLUCOSE WAS MEASURED AT ¿48 MG/DL¿ ON THE CLINIC DEVICE. DURING THE CALL, THE PATIENT CLAIMED SHE RECEIVED UNSPECIFIED TREATMENT AND WAS REPORTEDLY ADVISED TO INCREASE HER DAILY DOSE OF METFORMIN MED

  Patient problems: Hypoglycemia

  MAUDE report 7220952 ↗
• InjuryNov 3, 2017Bent; Bent

  ON (B)(6) 2017 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH HER ONETOUCH ULTRA BLUE TEST STRIPS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST LISTENED AGAIN TO THE CALL RECORDING. THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN AROUND 1 MONTH AGO, HOWEVER COULD NOT REMEMBER THE SPECIFIC DATE OR TIME WHEN SHE NOTED THAT APPROXIMATELY HALF OF THE TEST STRIPS WERE BENT IN THE VIAL SHE RECEIVED FROM THE PHARMACY. THE PATIENT MANAGES HER DIABETES USING LANTUS INSULIN (SELF-ADJUSTS) AND SHE REPORTEDLY DECREASED HER FOOD/DRINK CONSUMPTION AND TOOK INSULIN AT THE TIME THE PRODUCT ISSUE OCCURRED. THE PATIENT CLAIMED EXPERIENCING SYMPTOMS OF ¿SHAKING, DIZZY AND LIGHT-HEADED¿ AN UNSPECIFIED AMOUNT OF TIME AFTER THE ALLEGED ISSUE BEGAN, AND REPORTEDLY VISITED THE HOSPITAL WHERE SHE RECEIVED HCP TREATMENT OF ¿SWEET FOOD AND APPLE JUICE¿ IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT CONFIRMED THAT HER BLOOD GLUCOSE WAS NOT MEASURED USING ANY OTHER DEVICE AT THE TIME. THE CSR WAS UNABLE TO RESOLVE THE ISSUE DURING TROUBLESHOOTING. REPLACEMENT PROD

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 6998549 ↗