OneTouch Ultramini 021-913Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00353885002684), received between Jan 17, 2017 and Jul 25, 2019 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 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 ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿83, 150 AND 173 MG/DL ¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8825260 ↗
• MalfunctionJun 11, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY [HIGH/LOW] COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿91 MG/DL¿ WITH THE SUBJECT METER AND ¿71 MG/DL¿ ON THE LABORATORY DEVICE. THE TESTS WERE PERFORMED WITHIN 10-30 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8685895 ↗
• MalfunctionApr 25, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿80, 144 AND 89 MG/DL ¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8548205 ↗
• InjuryAug 2, 2018Loss of Power; Loss of Power

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT DESPITE A RECENT BATTERY CHANGE, THE METER WOULD NOT POWER ON AT 3PM ON (B)(6) 2018. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. SHE REPORTED THAT AS A RESULT OF THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL. SHE INDICATED THAT AT ABOUT 4PM ON (B)(6) 2018, SHE BECAME ¿SHAKY¿. SHE STATED THAT AT 6:30PM ON (B)(6) 2018, SHE ATE CHEESE TO ¿RELIEVE¿ HER SHAKINESS AND FELT BETTER A SHORT TIME LATER. NO ADDITIONAL ASSISTANCE WAS SOUGHT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE METER WAS NOT BEING USED FOR THE FIRST TIME. BASED ON THE INFORMATION PROVIDED THERE HAD BEEN NO MISUSE OF THE METER. THE PATIENT CONFIRMED THAT SHE WAS USING THE CORRECT TEST STRIPS BUT THE METER WOULD NOT TURN ON WHEN A NEW TEST STRIPS WAS INSERTED PER OWNER¿S MANUAL OR WHEN THE POWER BUTTON WAS PRESSED. BASED ON THE INFORMATION PROVIDED, THE METER¿S BATTERY DID NOT NEED TO BE REPLACED. THE ISSUE COULD NOT BE RESOLVED WITH TRAI

  Patient problems: Shaking/Tremors

  MAUDE report 7741842 ↗
• InjuryFeb 27, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2018, THE PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA MINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER (PARAMEDICS METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED WHEN MEDICAL SURVEILLANCE SPECIALIST (MSS) MADE A FOLLOW UP CALL. THE PATIENT STATED THAT THE ISSUE FIRST OCCURRED ON (B)(6) 2018, TIME UNKNOWN. THE PATIENT DETAILED THAT HE TESTED HIS BLOOD AND OBTAINED AN ALLEGED GLUCOSE RESULT OF 40MG/DL ON THE SUBJECT METER COMPARED TO 29MG/DL ON THE OTHER METER. 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 STATED THAT HE MANAGES HIS DIABETES INSULIN (NON-ADJUSTER) AND MADE NO CHANGE TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT DETAILED TO MSS THAT ON AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN HE HAD BECOME ¿UNCONSCIOUS¿ AND RECEIVED HCP TREATMENT OF IV GLUCOSE FROM THE PARAMEDICS. AT THE TIME OF TROUBLE SHOOTIN

  Patient problems: Fainting

  MAUDE report 7298624 ↗
• InjuryNov 15, 2017Loss of Power; Loss of Power

  ON (B)(6) 2017 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER POWER ISSUE BEGAN ON (B)(6) 2017 (TIME NOT SPECIFIED). THE PATIENT MANAGES HER DIABETES USING INSULIN (NO ADJUSTMENTS) AND REPORTEDLY CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE (34 UNITS LANTUS, 16 ¿ 20 UNITS HUMALOG) AFTER THE REPORTED ISSUE BEGAN. THE PATIENT STATED THAT SHE DEVELOPED SYMPTOMS OF ¿VERY DIZZY, HEADACHE AND VERY THIRSTY¿ ON (B)(6) AND IN THE MORNING OF (B)(6) SHE FELT ¿VERY SICK¿ AND VISITED THE EMERGENCY ROOM (ER) WHERE HER BLOOD GLUCOSE WAS MEASURED USING AN ER METER, ALTHOUGH SHE STATED SHE WAS NOT TOLD THE RESULT. THE PATIENT REPORTEDLY RECEIVED HCP TREATMENT OF 10 TO 20 UNITS OF INSULIN IN RESPONSE TO THE REPORTED EVENT. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE METER BATTERY DID NOT REQUIRE TO BE REPLACED; THE CORRECT TEST STRIPS WERE BEING USED; IT WAS NOT THE PATIENT¿S FIRST USE OF THE PRODUCT AND THERE HAD BEEN NO MISUSE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. TH

  Patient problems: Dizziness; Headache; Polydipsia

  MAUDE report 7032005 ↗
• InjuryOct 26, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2017 THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. THE CUSTOMER CARE ADVOCATE (CCA) ATTEMPTED TO CONTACT THE PATIENT WITH FOLLOW UP QUESTIONS FROM MEDICAL SURVEILLANCE BUT THEY WERE UNABLE TO REACH THE PATIENT. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE ORIGINAL CCA DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN AT 1:59PM ON (B)(6). THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF 290, 484 AND 544MG/DL ON THE SUBJECT METER. LIFESCAN COULD NOT CONFIRM THE TIMING OF THESE READINGS AS WE WERE UNABLE TO REACH THE PATIENT. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION BUT THEY WERE UNABLE TO PROVIDE FURTHER DETAILS. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿DIZZINESS, WENT INTO A COMA AND KIDNEYS SHUT DOWN¿. THE PATIENT REPORTED BEING TREATED AT THE EMERGENCY ROOM AT 5:30PM ON (B)(6). THE PATIENT DID NOT PROVIDE FURTHER DETAILS OF THE TREATMENT RECEIVED. LIFESCAN WERE UNABLE TO CONFIRM IF THE REPORTED COMA WAS ASSOCIATED WITH AN ACUTE BLOOD GLUCOSE EXCURSION. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE PATIENT D

  Patient problems: Coma; Dizziness; Renal Failure

  MAUDE report 6978962 ↗
• MalfunctionMar 19, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2017, THE LAY USER/PATIENT¿S WIFE (REPORTER), CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER STATED THAT THEY FIRST NOTICED THE ALLEGED METER INACCURACY ISSUE AROUND (B)(6) 2017, AT 8/8.30 AM, CLAIMING THAT THEY OBTAINED AN INACCURATE BLOOD GLUCOSE RESULT OF ¿160, 180 AND 39 MG/DL¿ ON THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS OUT WITH LFS¿ CRITERIA FOR PRECISION. THE REPORTED STATED THAT THE PATIENT MANAGES HIS DIABETES WITH GLYBURIDE AND JANUMET, AND DENIES THAT HE MADE ANY CHANGES TO HIS NORMAL DIABETES MANAGEMENT REGIMEN. THE REPORTER STATED THAT AROUND 8/830 AM, THE PATIENT HAD DEVELOPED SYMPTOMS OF ¿SHAKY, SWEATY AND DIZZY¿, AND WHEN THEY TESTED THEIR BLOOD GLUCOSE THEY OBTAINED THE RESULTS ABOVE. THE REPORTER STATED THAT THE PATIENT SELF-TREATED THE SYMPTOMS BY DRINKING SOME PEPSI. A BLOOD GLUCOSE RESULT OF ¿140 MG/DL¿ WAS OBTAINED ON ANOTHER METER ON (B)(6) 2017, THE TIME OF THIS RESU

  Patient problems: Dizziness; Shaking/Tremors; Sweating

  MAUDE report 6416256 ↗
• InjuryJan 17, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON 01/09/2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY OCCURRED AT 6PM ON (B)(6) 2017. AT THIS TIME THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿104MG/DL¿ WITH THE SUBJECT METER AND ¿33MG/DL¿ ON ANOTHER METER WITHIN 30 MINUTES OF ONE ANOTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT MANAGES THEIR DIABETES BY SELF-ADJUSTING THEIR INSULIN DOSAGE AND DID NOT STATE WHETHER THEY HAD TAKEN ANY ACTION WITH REGARD TO THEIR NORMAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT STATED THAT AN UNSPECIFIED PERIOD OF TIME BEFORE THE ALLEGED INACCURACY OCCURRED THEY WERE ¿UNRESPONSIVE¿ AND AS A RESULT WERE TAKEN TO THE EMERGENCY ROOM (E.R). IN E.R THEY WERE TREATED WITH FOOD AND/OR DRINK BY A HEALTHCARE PROFESSIONAL AND THE BLOOD GLUCOSE RESULT OF ¿33MG/DL¿ WAS OBTAINED AT THIS TIME. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT

  Patient problems: Loss of consciousness

  MAUDE report 6255418 ↗