OneTouch Ultramini 021-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00353885000512), received between Nov 2, 2017 and Sep 9, 2019 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 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 LOW COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿345 MG/DL¿ WITH THE SUBJECT METER AND ¿490 MG/DL¿ ON THE LABORATORY DEVICE. THE TESTS WERE PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS WITHIN LIFESCAN¿S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING RULED OUT AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION(S): THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. IN ADDITION, THERE WAS NO EVIDENCE THAT THE PRODUCT MALFUNCTIONED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8974344 ↗
• InjuryAug 9, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, THE PATIENT CONTACTED LIFESCAN USA, ALLEGING THAT HER ONETOUCH ULTRA MINI METER WAS READING INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON LIMITED INFORMATION CUSTOMER SERVICE REPRESENTATIVE (CSR) MANAGED TO OBTAIN FROM PATIENT BEFORE SHE DISCONTINUED THE CALL. CSR NOTED THAT SHE WAS UNABLE TO IDENTIFY WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT ALLEGED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF "300, 264 AND 100 MG/DL" ON THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THESE READINGS EXCEED LIFESCAN'S CRITERIA FOR PRECISION. IT IS UNKNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF ANY CHANGES WERE MADE TO HER NORMAL DIABETES MANAGEMENT REGIMEN. THE ONLY INFORMATION MADE AVAILABLE TO THE CSR WAS THAT AFTER THE PRODUCT ISSUE SHE HAD DEVELOPED SYMPTOMS OF "SWEATING". IT IS UNKNOWN IF THE ALLEGED SYMPTOMS REQUIRED ANY TREATMENT. DURING TROUBLESHOOTING THE CSR NOTED THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED, THERE WAS NO OBVIOUS MISUSE OF THE METER, THE CORRECT TEST STRIPS WERE BEING USED, AND THE PATIENT DESCRIBED THE CORRECT TESTING STEPS. THE CSR CONFIRMED THAT THE PATIENT'S TEST STRIPS

  Patient problems: Sweating

  MAUDE report 8878455 ↗
• InjuryAug 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(4) 2019, THE PATIENT CONTACTED LIFESCAN USA, ALLEGING THAT HER ONETOUCH ULTRA MINI METER WAS READING INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON LIMITED INFORMATION CUSTOMER SERVICE REPRESENTATIVE (CSR) MANAGED TO OBTAIN FROM PATIENT BEFORE SHE DISCONTINUED THE CALL. CSR NOTED THAT SHE WAS UNABLE TO IDENTIFY WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT ALLEGED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF ¿300, 264 AND 100 MG/DL¿ ON THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THESE READINGS EXCEED LIFESCAN¿S CRITERIA FOR PRECISION. IT IS UNKNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF ANY CHANGES WERE MADE TO HER NORMAL DIABETES MANAGEMENT REGIMEN. THE ONLY INFORMATION MADE AVAILABLE TO THE CSR WAS THAT AFTER THE PRODUCT ISSUE SHE HAD DEVELOPED SYMPTOMS OF ¿SWEATING¿. IT IS UNKNOWN IF THE ALLEGED SYMPTOMS REQUIRED ANY TREATMENT. DURING TROUBLESHOOTING THE CSR NOTED THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED, THERE WAS NO OBVIOUS MISUSE OF THE METER, THE CORRECT TEST STRIPS WERE BEING USED, AND THE PATIENT DESCRIBED THE CORRECT TESTING STEPS. THE CSR CONFIRMED THAT THE PATIENT¿S TEST STRIPS

  Patient problems: Sweating

  MAUDE report 8859272 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA MINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER (EMERGENCY SERVICES METER). THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THE METER ISSUE BEGAN AT 4.45 PM ON (B)(6) 2019, REPORTING THAT HE OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT OF "161 MG/DL" ON THE SUBJECT METER COMPARED TO "38 MG/DL" ON THE OTHER DEVICE. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER'S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. THE PATIENT REPORTED THAT HE MANAGES HIS DIABETES WITH INSULIN AND METFORMIN AND MADE NO CHANGES TO HIS NORMAL DIABETES MANAGEMENT REGIMEN. THE PATIENT WAS UNABLE TO DESCRIBE ANY SYMPTOMS HE DEVELOPED BUT STATED AT 5 PM ON (B)(6) 2019 HE WAS TREATED BY PARAMEDICS WITH IV GLUCOSE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, AND AN APPROVED SAMPLE SITE WAS USED. THE CSR NOTED THAT THE PATIENT DID NOT HAVE CON

  Patient problems: No Information

  MAUDE report 8802069 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA MINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER (EMERGENCY SERVICES METER). THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THE METER ISSUE BEGAN AT 4.45 PM ON (B)(6) 2019, REPORTING THAT HE OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT OF ¿161 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿38 MG/DL¿ ON THE OTHER DEVICE. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. THE PATIENT REPORTED THAT HE MANAGES HIS DIABETES WITH INSULIN AND METFORMIN AND MADE NO CHANGES TO HIS NORMAL DIABETES MANAGEMENT REGIMEN. THE PATIENT WAS UNABLE TO DESCRIBE ANY SYMPTOMS HE DEVELOPED BUT STATED AT 5 PM ON (B)(6) 2019 HE WAS TREATED BY PARAMEDICS WITH IV GLUCOSE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, AND AN APPROVED SAMPLE SITE WAS USED. THE CSR NOTED THAT THE PATIENT DID NOT HAVE CON

  Patient problems: No Information

  MAUDE report 8766354 ↗
• InjuryAug 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(4) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED FOLLOWING A REVIEW OF THE CALL BY A SENIOR CCA. THE PATIENT REPORTED THAT THE METER HAD BEEN READING INACCURATELY FOR ABOUT 3 MONTHS PRIOR TO CONTACTING LFS. SHE ALLEGED THAT ON AN UNSPECIFIED DATE/TIME, SHE OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT OF ¿119 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿ BELOW 30 MG/DL¿ ON AN EMERGENCY MEDICAL SERVICES (EMS) METER, PERFORMED GREATER THAN 30 MINUTES APART. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. THE PATIENT MANAGES HER DIABETES WITH INSULIN, WHICH SHE SELF-ADJUSTS. SHE ALLEGED THAT ON AN UNSPECIFIED DATE/TIME HER HUSBAND FOUND HER ¿OUT OF IT, SWEATY AND DIZZY¿. SHE INDICATED THAT HER HUSBAND TWICE GAVE HER ORANGE JUICE AND THEN CALLED THE RESCUE SERVIC

  Patient problems: Confusion/ Disorientation; Dizziness; Sweating

  MAUDE report 7800298 ↗
• InjuryAug 1, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT SHE WAS OBTAINING ERRATIC RESULTS, ON HER ONETOUCH ULTRA MINI METER. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ISSUE FIRST BEGAN ON (B)(6) 2018, ALLEGING THAT SHE OBTAINED INACCURATE READINGS OF ¿496, 107, 121 AND 117 MG/DL¿ ON THE SUBJECT METER, THE TESTS WERE PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE AND MADE NO CHANGES TO HER NORMAL ROUTINE. THE PATIENT REPORTED THAT 10 DAYS AFTER THE METER ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF ¿SHAKINESS¿. SHE CONFIRMED THAT NO TREATMENT WAS RECEIVED OR REQUIRED. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, AND AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES. CSR NOTED THAT THE VIAL WAS NOT CRACKED OR BROKEN, THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT PASSED THEIR EXPIRY DATE. THE PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RE

  Patient problems: Shaking/Tremors

  MAUDE report 7738103 ↗
• InjuryNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH IN COMPARISON TO RESULTS OBTAINED ON ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2017 SHE OBTAINED A RESULT OF ¿196 MG/DL¿ ON THE SUBJECT METER WHICH SHE FELT WAS INACCURATELY HIGH IN COMPARISON TO A READING OF ¿179 MG/DL¿ OBTAINED ON ANOTHER DEVICE. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. IT IS UNKNOWN WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE HER DIABETES OR IF SHE MADE ANY CHANGES TO HER DIABETES MANAGEMENT ROUTINE. THE PATIENT REPORTED THAT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED SYMPTOMS OF ¿WEAK AND SHAKING¿ HOWEVER DID NOT SPECIFY RECEIVING ANY TREATMENT. DURING TROUBLESHOOTING THE CCA NOTED THAT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND AN APPROVED SAMPLE SITE WAS USED. PRODUCT WAS REPLACED AND REQUESTED BACK. THIS COMPLAINT IS BEING REPOR

  Patient problems: Shaking/Tremors; Weakness

  MAUDE report 6995610 ↗