OneTouch Ultramini 021-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 00353885011464), received between Nov 30, 2016 and Jul 13, 2022 — classified as 198 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (136 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 25 most recent of 286 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH ULTRA EASY METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN 1 WEEK PRIOR TO CONTACTING LFS WHEN THEY OPENED A NEW VIAL OF STRIPS (EXACT DATE AND TIME NOT COMMUNICATED). THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES WITH A FIXED DOSE OF REGULAR INSULIN AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT A FEW DAYS PRIOR TO CONTACTING LFS (EXACT DATE AND TIME NOT COMMUNICATED), THEY DEVELOPED HYPOGLYCEMIC SYMPTOMS OF FEELING ¿HUNGRY AND SWEATY¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED THEY TESTED THEIR BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED AN ALLEGED INACCURATE HIGH RESULT OF ¿160 MG/DL.¿ DESPITE THE ELEVATED READING, THE PATIENT CLAIMED THEY ATE FOOD AS SELF-TREATMENT FOR THE SYMPTOMS. THE PATIENT INFORMED THE CCA THAT MEDICAL INTERVENTION WAS NOT REQUIRED AS GENERALLY THEY HAVE A TENDENCY OF HYPOGLYCEMIA. THE PATIE

  Patient problems: Diaphoresis; Hypoglycemia; Increased Appetite

  MAUDE report 15009252 ↗
• InjuryJul 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH ULTRA EASY METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN 1 WEEK PRIOR TO CONTACTING LFS WHEN THEY OPENED A NEW VIAL OF STRIPS (EXACT DATE AND TIME NOT COMMUNICATED). THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES WITH A FIXED DOSE OF REGULAR INSULIN AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT A FEW DAYS PRIOR TO CONTACTING LFS (EXACT DATE AND TIME NOT COMMUNICATED), THEY DEVELOPED HYPOGLYCEMIC SYMPTOMS OF FEELING ¿HUNGRY AND SWEATY¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED THEY TESTED THEIR BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED AN ALLEGED INACCURATE HIGH RESULT OF ¿160 MG/DL.¿ DESPITE THE ELEVATED READING, THE PATIENT CLAIMED THEY ATE FOOD AS SELF-TREATMENT FOR THE SYMPTOMS. THE PATIENT INFORMED THE CCA THAT MEDICAL INTERVENTION WAS NOT REQUIRED AS GENERALLY THEY HAVE A TENDENCY OF HYPOGLYCEMIA. THE PATIE

  Patient problems: Diaphoresis; Hypoglycemia; Increased Appetite

  MAUDE report 15009216 ↗
• InjurySep 10, 2019Loss of Power; Loss of Power

  ON (B)(6) 2019, A REPORTER FOR THE PATIENT (THE PATIENT'S WIFE) CONTACTED LIFESCAN (LFS) USA, TO REPORT THAT THE PATIENT'S ONETOUCH ULTRAMINI METER WOULD NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE METER STOPPED POWERING ON, ON (B)(6) 2019; SHE REPORTED THAT SHE THEN BOUGHT BATTERIES AND INSERTED THEM INTO THE METER, BUT STILL THE METER WOULD NOT TURN ON. THE PATIENT MANAGES HIS DIABETES WITH NOVOLIN INSULIN (NO ADJUSTMENTS). THE REPORTER DENIED THAT THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE AFTER THE METER STOPPED POWERING ON. SHE INDICATED THAT ON (B)(6) 2019, THE PATIENT DEVELOPED SYMPTOMS OF "DIZZINESS AND BLURRY VISION". SHE DENIED THAT THE PATIENT RECEIVED 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 THE METER WAS NOT BEING USED FOR THE FIRST TIME. BASED ON THE INFORMATION PROVIDED THERE HAD BEEN NO MISUSE OF THE METER. THE REPORTER CONFIRMED THAT THE PATIENT WAS USING CORRECT ONETOUCH ULTRA TEST STRIPS. HOWEVER, THE METER DID NOT TURN ON WHEN THE POWER BUTTON WAS

  Patient problems: Blurred Vision; Dizziness

  MAUDE report 8981189 ↗
• 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 ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿287 AND 168 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 8974152 ↗
• InjurySep 6, 2019Loss of Power; Loss of Power

  ON (B)(6) 2019, A REPORTER FOR THE PATIENT (THE PATIENT¿S WIFE) CONTACTED LIFESCAN (LFS) USA, TO REPORT THAT THE PATIENT¿S ONETOUCH ULTRAMINI METER WOULD NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE METER STOPPED POWERING ON, ON (B)(6) 2019; SHE REPORTED THAT SHE THEN BOUGHT BATTERIES AND INSERTED THEM INTO THE METER, BUT STILL THE METER WOULD NOT TURN ON. THE PATIENT MANAGES HIS DIABETES WITH NOVOLIN INSULIN (NO ADJUSTMENTS). THE REPORTER DENIED THAT THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE AFTER THE METER STOPPED POWERING ON. SHE INDICATED THAT ON (B)(6) 2019, THE PATIENT DEVELOPED SYMPTOMS OF ¿DIZZINESS AND BLURRY VISION¿. SHE DENIED THAT THE PATIENT RECEIVED 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 THE METER WAS NOT BEING USED FOR THE FIRST TIME. BASED ON THE INFORMATION PROVIDED THERE HAD BEEN NO MISUSE OF THE METER. THE REPORTER CONFIRMED THAT THE PATIENT WAS USING CORRECT ONETOUCH ULTRA TEST STRIPS. HOWEVER, THE METER DID NOT TURN ON WHEN THE POWER BUTTON WAS

  Patient problems: Blurred Vision; Dizziness

  MAUDE report 8968729 ↗
• MalfunctionSep 5, 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 ¿299 AND 216 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 8964419 ↗
• MalfunctionSep 4, 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 ¿256 AND 130 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 8959093 ↗
• MalfunctionAug 30, 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 ¿210 AND 150 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 8949083 ↗
• MalfunctionAug 30, 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 ¿250 AND 90 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 8949062 ↗
• MalfunctionAug 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON 08/28/2019, THE REPORTER CONTACTED LIFESCAN UNITED STATES, ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿400 AND 200 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 8948885 ↗
• MalfunctionAug 28, 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 HIGH COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿121 MG/DL ¿ WITH THE SUBJECT METER AND ¿90 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 EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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 8939911 ↗
• MalfunctionAug 28, 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 ¿209 AND 369 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 8938841 ↗
• MalfunctionAug 27, 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 HIGH COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿225 MG/DL¿ WITH THE SUBJECT METER AND ¿125 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 EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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 8935650 ↗
• MalfunctionAug 27, 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 ¿31 AND 161 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 8934507 ↗
• MalfunctionAug 20, 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 ¿159 AND 124 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 8909435 ↗
• MalfunctionAug 16, 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 ¿190, 155 AND 119 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 8900823 ↗
• InjuryAug 16, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2019, A REPORTER FOR THE PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER DISPLAYED ERROR 3 MESSAGES. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION FOLLOWING A REVIEW OF THE CALL BY A SENIOR CCA AND A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT STARTING AROUND 5PM ON (B)(6) 2019, WHEN THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE LEVEL, THE METER SHOWED ERROR 3 MESSAGES. THE PATIENT MANAGES HER DIABETES WITH 80 UNITS OF TRESIBA INSULIN (NO ADJUSTMENTS). THE REPORTER DENIED THAT THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER STATED THAT AN UNKNOWN TIME LATER, THE PATIENT DEVELOPED "SLURRED SPEECH"; THE REPORTER DID NOT KNOW IF THIS WAS ASSOCIATED WITH A HIGH OR LOW BLOOD GLUCOSE EXCURSION. THE REPORTER DENIED THAT THE PATIENT RECEIVED ANY TREATMENT FOR HER SYMPTOM. DURING TROUBLESHOOTING, THE REPORTER DESCRIBED THE CORRECT TESTING STEPS. THE CCA WALKED THE REPORTER/PATIENT THROUGH A RETEST, BUT THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE

  Patient problems: Dysphasia

  MAUDE report 8900728 ↗
• MalfunctionAug 15, 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 ¿104, 260 AND 142 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 8896835 ↗
• MalfunctionAug 15, 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 HIGH COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿208 MG/DL¿ WITH THE SUBJECT METER AND ¿130 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 EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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 8896722 ↗
• InjuryAug 14, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2019, A REPORTER FOR THE PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER DISPLAYED ERROR 3 MESSAGES. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION FOLLOWING A REVIEW OF THE CALL BY A SENIOR CCA AND A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT STARTING AROUND 5PM ON (B)(6) 2019, WHEN THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE LEVEL, THE METER SHOWED ERROR 3 MESSAGES. THE PATIENT MANAGES HER DIABETES WITH 80 UNITS OF TRESIBA INSULIN (NO ADJUSTMENTS). THE REPORTER DENIED THAT THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER STATED THAT AN UNKNOWN TIME LATER, THE PATIENT DEVELOPED ¿SLURRED SPEECH¿; THE REPORTER DID NOT KNOW IF THIS WAS ASSOCIATED WITH A HIGH OR LOW BLOOD GLUCOSE EXCURSION. THE REPORTER DENIED THAT THE PATIENT RECEIVED ANY TREATMENT FOR HER SYMPTOM. DURING TROUBLESHOOTING, THE REPORTER DESCRIBED THE CORRECT TESTING STEPS. THE CCA WALKED THE REPORTER/PATIENT THROUGH A RETEST, BUT THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE

  Patient problems: Dysphasia

  MAUDE report 8892252 ↗
• MalfunctionAug 12, 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 ¿312, 194, 261 AND 176 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 8883342 ↗
• MalfunctionAug 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 ERRATIC. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿330, 88 AND 185 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 8877683 ↗
• MalfunctionAug 7, 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 ¿111 AND 154 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 8868319 ↗
• MalfunctionAug 6, 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 ¿282 AND 168 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 8863936 ↗
• MalfunctionAug 5, 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 ¿394 AND 265 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 8858787 ↗