OneTouch Ultramini 021-514Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00353885008167), received between Nov 30, 2016 and Jul 16, 2019 — classified as 71 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (23 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 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 ¿103 AND 331 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 8793335 ↗
• MalfunctionJul 10, 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 ¿46, 198 AND 360 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 8775395 ↗
• InjuryJun 13, 2019Device Handling Problem; Device Handling Problem

  ON (B)(6) 2019, 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 FOLLOWING A REVIEW OF THE CALL BY A SENIOR CCA. THE PATIENT REPORTED THAT THE SUBJECT METER WAS READING INACCURATELY BETWEEN 10PM AND 11PM ON (B)(6) 2019, WHEN SHE OBTAINED ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULTS OF ¿315 AND 276 MG/DL¿ ON THE SUBJECT METER, COMPARED TO ¿167 AND 137 MG/DL¿ ON A BAYER CONTOUR 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 MANAGES HER DIABETES WITH INSULIN WHICH SHE SELF-ADJUSTS. SHE REPORTED THAT AFTER OBTAINING THE ¿HIGH¿ READINGS, SHE ADMINISTERED AN ADDITIONAL 2 UNITS OF FAST ACTING INSULIN. SHE REPORTED THAT AROUND MIDNIGHT ON (B)(6), SHE ¿LOST BALANCE AND PASSED OUT¿. SHE STATED THAT HER HUSBAND CALLED THE PARAMEDICS, A BLOOD GLUCOSE RESULT OF 26 MG/DL WAS OBTAINED ON THE ER/HOSPITAL METER.

  Patient problems: Fainting; Vertigo

  MAUDE report 8694579 ↗
• InjuryJun 11, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA MINI METER WAS DISPLAYING AN UNKNOWN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE FIRST APPEARED APPROXIMATELY THREE MONTHS PRIOR TO CONTACTING LFS. SHE STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN; 2000MG PER DAY), DIET AND EXERCISE, AND EXPLAINED THAT SHE DID NOT TAKE ANY ACTION IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT INFORMED THE CSR THAT AFTER THE PRODUCT ISSUE STARTED, SHE BEGAN TO EXPERIENCE ¿SWEATING AND A HEADACHE¿ BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO HER SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE ALLEGED PRODUCT 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 SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING DUE TO THE PRODUCT ISSUE.

  Patient problems: Headache; Sweating

  MAUDE report 8685874 ↗
• MalfunctionMay 28, 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 ¿500 AND 100 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 8644739 ↗
• MalfunctionMay 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HER ONETOUCH ULTRA MINI METER DISPLAYED INACCURATELY ERRATIC RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE SUBJECT METER STARTED READING INACCURATELY ERRATIC ON (B)(6) 2019, 11:30PM. SHE REPORTEDLY OBTAINED ALLEGED INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS OF ¿145, AND 95MG/DL¿, PERFORMED LESS THAN 20 MINUTES APART. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THE REPORTED RESULTS, EXCEEDS LFS¿ PRECISION CRITERIA. THE PATIENT STATED THAT HALF AN HOUR PRIOR TO OBTAINING THESE READINGS SHE EXPERIENCED THE SYMPTOM OF ¿HEADACHE , NAUSEA AND DIZZINESS¿. THE PATIENT MANAGES HER DIABETES WITH DIET AND EXERCISE AND REPORTED THAT SHE SELF TREATED WITH FOOD ¿STRAWBERRY FLAVOURED YOGURT AND FRUITS¿. THE PATIENT DENIED THAT SHE USED ANOTHER DEVICE TO OBTAIN A BLOOD GLUCOSE RESULT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE SAMPLES HAD BEEN TAKEN FROM THE SAME APPROVED SAMPLE SITE. THE PATIENT DESCRIBED THE CORRECT TESTING STEPS. SHE CONFIRMED TH

  Patient problems: Dizziness; Headache; Nausea

  MAUDE report 8630788 ↗
• MalfunctionMay 17, 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 ¿44 AND 70 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 8618734 ↗
• MalfunctionMay 17, 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 ¿93, 68, 50 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 8618730 ↗
• 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 ¿409 AND 305 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 8548177 ↗
• InjuryApr 9, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ADVISED THE CSR THAT ON (B)(6) 2019 AT 6.00PM, SHE OBTAINED AN INACCURATELY HIGH RESULT OF ¿197 MG/DL¿ ON THE SUBJECT METER, COMPARED TO HER FEELINGS/NORMAL RESULTS. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF DIABETES MEDICATIONS (METFORMIN; UNSPECIFIED DOSAGE, NOVOLOG; SLIDING SCALE AND LEVEMIR; UNSPECIFIED DOSAGE). SHE STATED THAT, AROUND DINNER TIME, SHE TOOK HER USUAL DOSE OF MEDICATION (12 UNITS OF INSULIN) IN RESPONSE TO THE ALLEGED INACCURATE HIGH READING. THE PATIENT EXPLAINED THAT ON (B)(6) 2019 AT 12.38AM, SHE EXPERIENCED SYMPTOMS OF ¿SWEATY AND DIZZY¿. SHE STATED THAT SHE PERFORMED ANOTHER BLOOD GLUCOSE TEST AND OBTAINED A READING OF ¿56 MG/DL¿ SHE EXPLAINED THAT SHE SELF-TREATED HER SYMPTOMS WITH A GLUCOSE TABLET AND A GLASS OF ORANGE JUICE IMMEDIATELY AFTE

  Patient problems: Dizziness; Sweating

  MAUDE report 8494546 ↗
• InjuryFeb 24, 2019Loss of Power; Loss of Power

  ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER POWER ISSUE BEGAN ON (B)(6) 2019 AT 6 AM. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH 1000 MG OF METFORMIN IN THE MORNING AND EVENING AS WELL AS A COMBINATION OF INSULIN SHOTS; 3 SHORT-ACTING AND 1 LONG-ACTING DAILY (TYPES AND DOSES UNSPECIFIED). THE PATIENT REPORTED THAT IN RESPONSE TO THE ALLEGED POWER ISSUE WITH THE SUBJECT METER SHE JUST CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT CLAIMED THAT 3 DAYS AFTER THE ALLEGED POWER ISSUE BEGAN SHE DEVELOPED SYMPTOMS OF FEELING ¿FATIGUED AND SLEEPY ALL DAY¿. THE PATIENT DENIED RECEIVING ANY TREATMENT OR MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND BASED ON THE INFORMATION PROVIDED THERE APPEARED TO BE NO MISUSE TO THE PRODUCT. THROUGH TROUBLESHOOTING THE CSR DETERMINED THAT THE METER¿S BATTERY NEEDED REPLACED. HOWEVER, THE PATIENT DID NOT HAVE A

  Patient problems: Fatigue; Lethargy

  MAUDE report 8364820 ↗
• InjuryDec 18, 2018Device Handling Problem; Device Handling Problem

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER DISPLAYED AN INACCURATELY HIGH RESULT COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED THAT THE SUBJECT METER WAS READING INACCURATELY AT 12:13AM ON (B)(6)2018, WHEN SHE OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT OF ¿156 MG/DL¿ ON BOTH THE SUBJECT METER AND ANOTHER ONETOUCH ULTRAMINI METER. THE PATIENT MANAGES HER DIABETES WITH LEVEMIR AND HUMULIN R INSULIN AND METFORMIN ORAL MEDICATION. THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER OBTAINING THE ALLEGED INACCURATE RESULT. SHE REPORTED THAT AROUND 2 HOURS LATER, AT 2AM ON (B)(6) 2018, HER FAMILY WERE UNABLE TO WAKE HER UP AS SHE HAD ¿PASSED OUT¿ AND BEEN INCONTINENT. SHE INDICATED THAT THE FAMILY GAVE HER APPLE JUICE TO TREAT HER SYMPTOMS AND CALLED THE EMERGENCY MEDICAL SERVICES (EMS). SHE REPORTED THAT WHEN THE PARAMEDICS ARRIVE AT 2:45AM, THEY OBTAINED A BLOOD GLUCOSE RESULT OF ¿23 MG/DL¿ ON THE EMS METER WHICH SHE COMPARED TO THE RESULT ON THE SUBJECT METER FROM A COUPLE OF HOURS PRE

  Patient problems: Extreme Exhaustion; Fainting; Incontinence

  MAUDE report 8172840 ↗
• InjuryDec 4, 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 HER ONETOUCH ULTRAMINI METER DISPLAYED INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE METER STARTED READING INACCURATELY FROM APPROXIMATELY 10 DAYS PRIOR TO CONTACTING LFS ON (B)(6) 2018, AT AN UNSPECIFIED TIME ONWARD. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF DIABETES MEDICATION (METFORMIN - TWICE A DAY (1000 MG EACH), LEVEMIR ¿ EVERY MORNING AND NIGHT (DOSE UNSPECIFIED), HUMALOG ¿ 3 UNITS A DAY). ON (B)(6) 2018 AROUND 5:30 PM THE PATIENT REPORTEDLY ¿FELT A SHAKING SENSATION AND PASSED OUT¿ ON THE SAME DAY. THE PATIENT CLAIMED THAT SHE TREATED HERSELF WITH 6-7 GLUCOSE TABLETS AND REPORTED SHE FELT BETTER AND STABLE AFTER. THE PATIENT DID NOT REPORT READINGS OBTAINED WITH THE SUBJECT METER FROM THIS DAY. ON (B)(6) 2018 IN THE MORNING, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿512 AND 430 MG/DL¿ ON THE SUBJECT METER, WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESUL

  Patient problems: Fainting; Shaking/Tremors

  MAUDE report 8127846 ↗
• InjuryNov 28, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, A REPORTER ON BEHALF OF THE LAY USER/PATIENT CONTACTED LIFESCAN(LFS) USA ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. IT WAS REPORTED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2018 AT AROUND 10-11:30 AM. THE REPORTER CLAIMED THAT THE PATIENT GOT A VALUE OF ¿104 MG/DL¿ WITH THE SUBJECT METER COMPARED TO A RESULT OF ¿40 MG/DL¿ WITH AN EMERGENCY MEDICAL SERVICE (EMS) METER. THE TESTS WERE PERFORMED AT THE SAME TIME. 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 A COMBINATION OF MEDICATIONS; METFORMIN TWICE DAILY, TRULICITY 180 UNITS ONCE A WEEK AND AN UNSPECIFIED INJECTION FOR HER DIABETES. IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE DUE TO THE ALLEGED INACCURACY ISSUE. THE REPORTER CLAIMED THAT ONE-HOUR PRIOR TO

  Patient problems: Fatigue

  MAUDE report 8109600 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT WAS UNABLE TO SPECIFY WHEN THE ALLEGED INACCURACY BEGAN BUT REPORTED THAT IT HAPPENED APPROXIMATELY 3 WEEKS AGO. THE PATIENT REPORTED THAT SHE OBTAINED AN INACCURATE HIGH READING OF "142 MG/DL" COMPARED TO A RESULT OF "118 MG/DL" ON AN UNKNOWN DEVICE, THE TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. 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 DIET AND EXERCISE AND REPORTED THAT SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE AFTER THE ALLEGED INACCURACY ISSUE BEGAN. THE PATIENT CLAIMED THAT AT AN UNSPECIFIED TIME SHE DEVELOPED SYMPTOMS OF "SWEATING, SHAKING AND DIZZINESS" WHICH SHE ASSOCIATED WITH SYMPTOMS OF LOW BLOOD SUGAR. THE PATIENT REPORTED THAT SHE WENT TO HER DOCTOR IN RESPONSE T

  Patient problems: Dizziness; Shaking/Tremors; Sweating

  MAUDE report 8068195 ↗
• InjuryOct 25, 2018Failure to Calibrate; Failure to Calibrate

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING HER ONE TOUCH ULTRAMINI METER DOESN'T TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE FIRST OCCURRED APPROXIMATELY ONE TO TWO WEEKS PRIOR TO CONTACTING LFS, AT AN UNSPECIFIED TIME. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (METFORMIN 1000 MG AND GLIPIZIDE 50 MG). THE PATIENT DID NOT SPECIFY WHETHER SHE MADE ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED POWER ISSUE. AT AN UNSPECIFIED DATE AND TIME, AFTER THE ALLEGED PRODUCT ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿SWEATING AND SHAKING¿. IT WAS NOT REPORTED IF THE PATIENT RECEIVED ANY TREATMENT FOR THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) CONFIRMED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THERE WAS NO INDICATION OF MISUSE TO THE DEVICE. THE PATIENT USED THE CORRECT TEST STRIPS. HOWEVER, THE CSR ALSO NOTED THAT INSERTING THE TEST STRIPS AS WELL AS PUSHING THE POWER BUTTON DID TURN THE SUBJECT METER

  Patient problems: Shaking/Tremors; Sweating

  MAUDE report 8003743 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER, HOSPITAL, METER. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED OBTAINING AN ALLEGED INACCURATELY HIGH RESULT WITH THE SUBJECT METER, ON (B)(6) 2018 AT 7:00AM, BUT SHE WAS UNABLE TO RECALL THE EXACT RESULT. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN ¿ SELF ADJUSTED AND IN RESPONSE TO THE ALLEGED INACCURATELY HIGH RESULT, SHE REPORTED TAKING AN, ¿INCREASED INSULIN INTAKE¿ BASED ON THE RESULTS SHE OBTAINED AND HOW THEY RELATED TO A SLIDING SCALE. THE PATIENT REPORTED THAT A FEW MINUTES LATER SHE DEVELOPED SYMPTOMS OF FEELING, ¿DIZZINESS, SWEATY, ABOUT TO FAINT¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT DENIED RECEIVING ANY TREATMENT OVER AND ABOVE HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT REPORTED BECOMING AWARE OF THE ALLEGED PRODUCT ISSUE WHEN SHE OBTAINED A RESULT OF, ¿345 MG/DL¿ WITH THE SUBJECT METER AND, ¿270 MG/DL¿ WITH THE HOSPITAL METER. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRE

  Patient problems: Dizziness; Sweating; Syncope

  MAUDE report 7972772 ↗
• InjurySep 27, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2018, A REPORTER ON BEHALF OF THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS DISPLAYING AN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATION (CSR) DOCUMENTATION AND FURTHER INFORMATION OBTAINED WHEN MEDICAL SURVEILLANCE REVIEWED THE INITIAL CALL. THE REPORTER CLAIMED THAT ABOUT A MONTH AGO (DATE NOT SPECIFIED) BEFORE CONTACTING LFS THE PATIENT WAS UNABLE TO OBTAIN RESULTS ON HER METER AS IT KEPT SHOWING THE MESSAGE "ERROR 5". THE REPORTER INFORMED THE CSR THAT THE PATIENT MANAGES HER DIABETES WITH HUMULIN 70/30 AND THAT SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE AFTER THE ALLEGED ISSUE BEGAN. THE REPORTED CLAIMED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE STARTED SHE ¿GOT SICK¿ BECAUSE SHE WAS UNABLE TO CHECK HER BLOOD SUGAR AND SPECIFIED THAT SHE ¿FELT FUNNY", WAS ¿GETTING LIGHTHEADED¿ AND ¿FALLING¿. THE REPORTER CLAIMED THAT IN RESPONSE TO THE PATIENT FALLING THEY WOULD HELP HER SIT DOWN, TREAT HER WITH FOOD AND DRINK AND SHE WOULD BE OK AFTER A COUPLE OF SECONDS. THE REPORTER ALSO CLAIMED THAT WHEN SHE WAS NOT THERE TO HELP (DATES NOT SPECIFIED), THE PATIENT WOULD

  Patient problems: Fainting

  MAUDE report 7913375 ↗
• InjurySep 5, 2018Battery Problem; Battery Problem

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRAMINI METER DISPLAYED THE BATTERY INDICATOR SYMBOL. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE METER DISPLAYED THE BATTERY INDICATOR SYMBOL AT 11:45 AM ON (B)(6) 2018. THE PATIENT MANAGES HER DIABETES WITH METFORMIN AND GLIPIZIDE ORAL MEDICATION. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER THE BATTERY SYMBOL APPEARED. SHE STATED THAT ABOUT 5 MINUTES LATER, SHE DEVELOPED SYMPTOMS OF ¿DIZZINESS AND SHAKINESS¿. SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THE METER WAS NOT BEING USED FOR THE FIRST TIME. BASED ON THE INFORMATION PROVIDED, THERE HAD BEEN NO MISUSE OF THE METER. ALSO, BASED ON THE INFORMATION PROVIDED, THE METER¿S BATTERY NEEDED TO BE REPLACED. AFTER CHANGING THE BATTERY, THE ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY ADVERSE EVENT, I.E. D

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 7845170 ↗
• InjuryAug 22, 2018Loss of Power; Loss of Power

  ON (B)(\6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT HER ONETOUCH ULTRA MINI METER HAD A POWER ISSUE - TURNS OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2018, 8:45AM. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (METFORMIN), DIET AND EXERCISE. IT IS UNCLEAR IF THE PATIENT MADE ANY CHANGE TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. SHE STATED THAT ¿A FEW MINUTES¿ AFTER THE ALLEGED PRODUCT ISSUE BEGAN, SHE DEVELOPED THE SYMPTOMS OF ¿DIZZY, HEADACHE AND SHAKY¿. THE PATIENT STATED THAT SHE SELF-TREATED WITH FOOD AND DRINK. ¿SWEETS¿. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT IT WAS NOT THE FIRST TIME THE METER WAS BEING USED, THERE WAS NO MISUSE OF THE METER. AFTER EDUCATING THE PATIENT ABOUT THE AUTO SHUT OFF, THE ISSUE REMAINED UNRESOLVED AND BASED ON THE INFORMATION PROVIDED THE BATTERY DID NOT REQUIRE TO BE REPLACED. THE PATIENT¿S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT THAT MEET LFS¿ CRITERIA F

  Patient problems: Dizziness; Headache; Shaking/Tremors

  MAUDE report 7804079 ↗
• InjuryAug 8, 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 HER ONETOUCH ULTRAMINI METER DISPLAYED INACCURATELY ERRATIC RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE SUBJECT METER STARTED READING INACCURATELY AT AN UNKNOWN TIME ON (B)(6) 2018; HOWEVER, SHE WAS UNABLE TO RECALL THE RESULTS. THE PATIENT MANAGES HER DIABETES WITH JANUMET 50/1000MG ORAL MEDICATION. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AS A RESULT OF THE ALLEGED ISSUE ; SHE INDICATED THAT SHE STUCK TO HER DIET AND EXERCISED. SHE REPORTED THAT AN UNKNOWN TIME AFTER OBTAINING THE ALLEGED INACCURATELY ERRATIC RESULTS, SHE DEVELOPED SYMPTOMS OF ¿NAUSEOUS, DIZZY, LIGHT HEADED AND HOT FLASHES¿. SHE REPORTED THAT DURING A DOCTOR¿S OFFICE VISIT HER DOCTOR DID ¿NOTHING¿ AS HE/SHE WAS TRYING TO FIGURE OUT WHAT WAS WRONG. NO OTHER TREATMENT FOR THE SYMPTOMS WAS REPORTED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE METER AND TEST STRIPS. REPLACEMENT PRODUCTS, INCLUDING CONTROL SOLUTI

  Patient problems: Dizziness; Hot Flashes/Flushes; Nausea

  MAUDE report 7760840 ↗
• InjuryAug 2, 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 THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED PRODUCT ISSUE OCCURRED AT 10:30PM ON (B)(6) 2018. AT THIS TIME, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿181MG/DL¿ WITH THE SUBJECT METER AND ¿54MG/DL¿ ON ANOTHER DEVICE WITHIN 30 MINUTES OF ONE ANOTHER. 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 THEIR DIABETES WITH 5MG GLIPIZIDE PER DAY AND DID NOT MAKE ANY CHANGES TO THEIR DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT DEVELOPED SYMPTOMS OF ¿INCOHERENT AND UNRESPONSIVE¿ 10 MINUTES LATER. IN RESPONSE TO THIS THE EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED. AT 10:45PM THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED ON THE EMS METER WITH THE RESULT OF ¿54MG/DL¿ BEING OBTAINED AT THIS TIME. IN RESPONSE TO THIS THE PATIENT

  Patient problems: Dysphasia; Loss of consciousness

  MAUDE report 7741745 ↗
• InjuryJul 19, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER DISPLAYED AN ERROR 5 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS THE PATIENT WAS UNABLE TO BE CONTACTED, DESPITE NUMEROUS ATTEMPTS, IN ORDER TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT DID NOT STATE WHEN THE ALLEGED PRODUCT ISSUE OCCURRED. THE PATIENT MANAGES THEIR DIABETES WITH X2 500MG METFORMIN TABLETS PER DAY AND DID NOT MAKE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED PRODUCT ISSUE. AN UNSPECIFIED TIME IN RELATION TO THE ALLEGED PRODUCT ISSUE THE PATIENT DEVELOPED SYMPTOMS OF ¿TIRED AND READY TO FALL OVER AND PASS OUT¿; HOWEVER, IT WAS DOCUMENTED THAT THE PATIENT DID NOT REQUIRE ANY FORM OF TREATMENT AS A RESULT OF THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT AND THIS WAS NOT THE FIRST TIME THE PRODUCT HAD BEEN USED. THE PATIENT¿S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT WHILE USING THE PRODUCT. THE A

  Patient problems: Fatigue; Syncope

  MAUDE report 7701628 ↗
• InjuryJul 11, 2018Device Alarm System; Device Alarm System

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA MINI METER WAS DISPLAYING A MESSAGE SAYING ¿HI¿. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE METER ISSUE BEGAN AT 5 PM ON (B)(6) 2018, WHEN SHE OBTAINED A MESSAGE ON THE SUBJECT METER, THAT SAID ¿HI¿. THE PATIENT REPORTED THAT SHE WAS UNAWARE WHAT THE MESSAGE MEANT. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF MEDICATION (METFORMIN AND INSULIN), AND THAT SHE MADE NO CHANGES TO HER NORMAL DIABETES MANAGEMENT. THE PATIENT STATED THAT SHE LEFT THE HOUSE TO BUY A NEW METER, AND THEN DEVELOPED SYMPTOMS OF ¿SHAKY, BLACKED OUT AND WOKE UP IN HOSPITAL¿. THE PATIENT WAS UNABLE TO CONFIRM WHAT TREATMENT SHE RECEIVED IN HOSPITAL. DURING TROUBLESHOOTING THE CSR NOTED THAT IT WAS NOT THE FIRST TIME THE PATIENT WAS USING THE METER. 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 PRODUCT ISSUE BEGAN. THERE IS INSUFFICIENT INFORMATION TO RULE OUT THE CO

  Patient problems: Fainting; Shaking/Tremors

  MAUDE report 7676649 ↗
• InjuryJul 9, 2018Device Handling Problem; Device Handling Problem

  ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA MINI METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO A LABORATORY DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THEY FIRST BECAME AWARE OF THE METER ISSUE, AROUND DINNER TIME ON (B)(6) 2018, REPORTING THAT THEY HAD OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT OF ¿350 MG/DL¿ ON THE SUBJECT METER COMPARED TO ¿130 MG/DL ON A LABORATORY DEVICE. THE TESTS WERE PERFORMED GREATER THAN 30 MINUTES OF EACH OTHER. THE CSR NOTED THAT THE PATIENT WAS UNABLE TO CONFIRM HOW THEY MANAGED THEIR DIABETES, BUT STATED THAT AFTER THE METER ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF ¿SHAKY¿, IN RESPONSE TO THESE SYMPTOMS, SHE DRANK SOME WATER AND WENT TO THE HOSPITAL AT 10PM. THE PATIENT STATED THAT A BLOOD TEST WAS TAKEN, THEN SHE WAS SENT HOME WITH NO OTHER TREATMENT. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, AND THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES, REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REP

  Patient problems: Shaking/Tremors

  MAUDE report 7669242 ↗