OneTouch Ultra2 021-098Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00353885000277), received between May 30, 2017 and Sep 16, 2022 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 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) UNITED STATES, ALLEGING THAT THEIR ONETOUCH ULTRA2 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 ON (B)(6) 2022. THE PATIENT MENTIONED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿OVER 400, 121, 471, 328 AND 150 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN ON A SELF-ADJUSTING DOSE. THE PATIENT CLAIMED THAT 2 DAYS AFTER THE ALLEGED ISSUE BEGAN, THEY ADMINISTERED AN INCREASED DOSE OF INSULIN (AMOUNT NOT SPECIFIED) DUE TO THE ALLEGED ISSUE AND BECAME ¿DIZZY AND SWEATY¿. THE PATIENT DENIED RECEIVING ANY TREATMENT ABOVE AND BEYOND THEIR USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT FOR THE REPORTED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECT AND WERE NOT EXPIRED OR OPENED PAST THEIR DIS

  Patient problems: Diaphoresis; Dizziness

  MAUDE report 15435818 ↗
• InjurySep 15, 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) UNITED STATES, ALLEGING THAT THEIR ONETOUCH ULTRA2 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 ON (B)(6) 2022. THE PATIENT MENTIONED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿OVER 400, 121, 471, 328 AND 150 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN ON A SELF-ADJUSTING DOSE. THE PATIENT CLAIMED THAT 2 DAYS AFTER THE ALLEGED ISSUE BEGAN, THEY ADMINISTERED AN INCREASED DOSE OF INSULIN (AMOUNT NOT SPECIFIED) DUE TO THE ALLEGED ISSUE AND BECAME ¿DIZZY AND SWEATY¿. THE PATIENT DENIED RECEIVING ANY TREATMENT ABOVE AND BEYOND THEIR USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT FOR THE REPORTED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECT AND WERE NOT EXPIRED OR OPENED PAST THEIR DIS

  Patient problems: Diaphoresis; Dizziness

  MAUDE report 15433422 ↗
• InjuryMay 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY LOW COMPARED TO HER FEELINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2021, SHE BEGAN OBTAINING WHAT SHE FELT WERE INACCURATE LOW BLOOD GLUCOSE READINGS IN THE ¿80S AND 90S MG/DL¿ RANGE WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN ON A SELF-ADJUSTING DOSE. THE PATIENT CLAIMED SHE STOPPED TAKING HER NIGHT TIME INSULIN ON (B)(6) 2021 AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AFTER THE ALLEGED ISSUE BEGAN, SHE DEVELOPED SYMPTOM OF ¿PEE A LOT;¿ SYMPTOM SHE ASSOCIATED WITH A HIGH BLOOD GLUCOSE. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT FOR HYPERGLYC

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 11867470 ↗
• InjuryMay 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY LOW COMPARED TO HER FEELINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2021, SHE BEGAN OBTAINING WHAT SHE FELT WERE INACCURATE LOW BLOOD GLUCOSE READINGS IN THE ¿80S AND 90S MG/DL¿ RANGE WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN ON A SELF-ADJUSTING DOSE. THE PATIENT CLAIMED SHE STOPPED TAKING HER NIGHT TIME INSULIN ON (B)(6) 2021 AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AFTER THE ALLEGED ISSUE BEGAN, SHE DEVELOPED SYMPTOM OF ¿PEE A LOT;¿ SYMPTOM SHE ASSOCIATED WITH A HIGH BLOOD GLUCOSE. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT FOR HYPERGLYC

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 11867469 ↗
• InjuryNov 16, 2020Loss of Power; Loss of Power

  ON (B)(6) 2020, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER WOULD NOT POWER ON AND SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN ON THE MORNING OF (B)(6) 2020. THE PATIENT MANAGES HER DIABETES WITH ISOPHANE INSULIN (SELF-ADJUSTER). THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN WHEN SHE WAS UNABLE TO PERFORM A BLOOD GLUCOSE TEST DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AT MIDDAY ON (B)(6) 2020, SHE STARTED TO FEEL "THIRSTY AND URINATE CONSTANTLY." IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED SHE TESTED HER BLOOD GLUCOSE ON A NEIGHBOR'S METER (ULTRA MINI) AND RESULT OF "OVER 600 MG/DL" WAS OBTAINED. SHE THEN CONTACTED HER DOCTOR WHO ADVISED HER TO GO TO THE EMERGENCY ROOM (ER) IMMEDIATELY. THE PATIENT CLAIMED SHE WAS TREATED AT THE ER WITH INTRAVENOUS (IV) FLUIDS AND INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THAT THERE WAS NO INDICATION OF MISUSE TO THE DEVICE. THE CCA CONFIRMED TH

  Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 10844064 ↗
• InjuryNov 16, 2020Loss of Power; Loss of Power

  ON (B)(6) 2020, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER WOULD NOT POWER ON AND SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN ON THE MORNING OF (B)(6) 2020. THE PATIENT MANAGES HER DIABETES WITH ISOPHANE INSULIN (SELF-ADJUSTER). THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN WHEN SHE WAS UNABLE TO PERFORM A BLOOD GLUCOSE TEST DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AT MIDDAY ON (B)(6) 2020, SHE STARTED TO FEEL "THIRSTY AND URINATE CONSTANTLY." IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED SHE TESTED HER BLOOD GLUCOSE ON A NEIGHBOR'S METER (ULTRA MINI) AND RESULT OF "OVER 600 MG/DL" WAS OBTAINED. SHE THEN CONTACTED HER DOCTOR WHO ADVISED HER TO GO TO THE EMERGENCY ROOM (ER) IMMEDIATELY. THE PATIENT CLAIMED SHE WAS TREATED AT THE ER WITH INTRAVENOUS (IV) FLUIDS AND INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THAT THERE WAS NO INDICATION OF MISUSE TO THE DEVICE. THE CCA CONFIRMED TH

  Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 10844058 ↗
• InjuryNov 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE PATIENT CONTACTED LIFESCAN (LFS) US, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT 01:00 ON (B)(6) 2020. THE PATIENT CLAIMED OBTAINING RESULTS OF "556 MG/DL" (01:00, (B)(6) 2020), "181 M/DL" (02:04, (B)(6) 2020), "261 MG/DL" (08:43, (B)(6) 2020) AND "204 MG/DL" (13:14, (B)(6) 2020) ON THE SUBJECT DEVICE. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION ("GLUCOZAN, 5 MG", AND "JARDIANCE, 10 MG"). THE PATIENT REPORTED THAT SHE TOOK "JARDIANCE, 25 MG AND, GLUCOZAN, 5 MG AFTER EACH TEST TAKEN" AND THAT SHE STOPPED EATING IN RESPONSE TO THE ALLEGED ELEVATED READINGS OBTAINED ON THE SUBJECT DEVICE. THE PATIENT REPORTED THAT AT 02:00 ON (B)(6) 2020, SHE BECAME "WEAK", STARTED TO "SWEAT" AND THAT SHE WAS "STARVING". THE PATIENT ADVISED THAT SHE WENT TO THE HOSPITAL AT 13:15 ON (B)(6) 2020, WHERE HER BLOOD GLUCOSE WAS REPORTEDLY TESTED AT "55, 56 AND 58 MG/DL" ON THE HOSPITAL DEVICE. THE PATIENT ADVISED THE CCA THAT SHE WAS SUBSEQUENTLY TREATED WITH ORANGE JUICE AND PEANUT BUTTER CRACKERS UN

  Patient problems: Diaphoresis; Fatigue; Increased Appetite

  MAUDE report 10780018 ↗
• InjuryNov 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE PATIENT CONTACTED LIFESCAN (LFS) US, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT 01:00 ON (B)(6) 2020. THE PATIENT CLAIMED OBTAINING RESULTS OF "556 MG/DL" (01:00, (B)(6) 2020), "181 M/DL" (02:04, (B)(6) 2020), "261 MG/DL" (08:43, 05 OCTOBER 2020) AND "204 MG/DL" (13:14, (B)(6) 2020) ON THE SUBJECT DEVICE. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION ("GLUCOZAN, 5 MG", AND "JARDIANCE, 10 MG"). THE PATIENT REPORTED THAT SHE TOOK "JARDIANCE, 25 MG AND, GLUCOZAN, 5 MG AFTER EACH TEST TAKEN" AND THAT SHE STOPPED EATING IN RESPONSE TO THE ALLEGED ELEVATED READINGS OBTAINED ON THE SUBJECT DEVICE. THE PATIENT REPORTED THAT AT 02:00 ON (B)(6) 2020, SHE BECAME "WEAK", STARTED TO "SWEAT" AND THAT SHE WAS "STARVING". THE PATIENT ADVISED THAT SHE WENT TO THE HOSPITAL AT 13:15 ON (B)(6) 2020, WHERE HER BLOOD GLUCOSE WAS REPORTEDLY TESTED AT "55, 56 AND 58 MG/DL" ON THE HOSPITAL DEVICE. THE PATIENT ADVISED THE CCA THAT SHE WAS SUBSEQUENTLY TREATED WITH ORANGE JUICE AND PEANUT BUTTER CRACKER

  Patient problems: Diaphoresis; Fatigue; Increased Appetite

  MAUDE report 10780008 ↗
• InjuryOct 8, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2020. THE PATIENT CLAIMED HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED READINGS OF "236, 269 AND 93 MG/DL" AT 8:00 AM, 9:00 AM, AND 9:01 AM RESPECTIVELY. THE PATIENT STATED THAT HE DOES NOT TAKE ANY MEDICATION TO MANAGE HIS DIABETES AND DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED INACCURATE RESULTS. THE PATIENT REPORTED THAT AFTER 9:00 AM ON SEPTEMBER 16, 2020, HE DEVELOPED SYMPTOMS OF "ANXIETY, CLAMMY AND PROBABLY RAISED BLOOD PRESSURE." THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA DOCUMENTED THAT THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA N

  Patient problems: Anxiety; Diaphoresis; High Blood Pressure/ Hypertension

  MAUDE report 10648522 ↗
• InjuryOct 8, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON THE MORNING OF (B)(6) 2020. THE PATIENT CLAIMED HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED READINGS OF "236, 269 AND 93 MG/DL" AT 8:00 AM, 9:00 AM, AND 9:01 AM RESPECTIVELY. THE PATIENT STATED THAT HE DOES NOT TAKE ANY MEDICATION TO MANAGE HIS DIABETES AND DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED INACCURATE RESULTS. THE PATIENT REPORTED THAT AFTER 9:00 AM ON SEPTEMBER 16, 2020, HE DEVELOPED SYMPTOMS OF "ANXIETY, CLAMMY AND PROBABLY RAISED BLOOD PRESSURE." THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA DOCUMENTED THAT THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA N

  Patient problems: Anxiety; Diaphoresis; High Blood Pressure/ Hypertension

  MAUDE report 10648520 ↗
• InjuryMay 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2020 AT 2:25 AM WHEN HE OBTAINED AN ALLEGED INACCURATE HIGH RESULT OF ¿96 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH LANTUS INSULIN ON A SELF-ADJUSTING DOSE. THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT A FEW MINUTES AFTER THE ALLEGED ISSUE OCCURRED, HE STARTED TO ¿FEEL LIKE PASSING OUT AND WAS SWEATING.¿ IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED HE SELF-TREATED WITH A GLUCOSE TABLET AND A BOOST NUTRITIONAL DRINK. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HIS BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. THE CSA NOTED THE PATIENT WAS TESTING

  Patient problems: Sweating; Syncope

  MAUDE report 10060767 ↗
• InjuryMay 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2020 AT 2:25 AM WHEN HE OBTAINED AN ALLEGED INACCURATE HIGH RESULT OF ¿96 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH LANTUS INSULIN ON A SELF-ADJUSTING DOSE. THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT A FEW MINUTES AFTER THE ALLEGED ISSUE OCCURRED, HE STARTED TO ¿FEEL LIKE PASSING OUT AND WAS SWEATING.¿ IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED HE SELF-TREATED WITH A GLUCOSE TABLET AND A BOOST NUTRITIONAL DRINK. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HIS BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. THE CSA NOTED THE PATIENT WAS TESTING

  Patient problems: Sweating; Syncope

  MAUDE report 10060766 ↗
• MalfunctionMay 29, 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 ¿411, 305 AND 295 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. IN ADDITION 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8648738 ↗
• InjuryJun 3, 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 ULTRA2 METER READ INACCURATELY HIGH IN COMPARISON WITH HER FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT COULD NOT SPECIFY WHEN THE ISSUE BEGAN HOWEVER STATED THAT SHE HAD OBTAINED RESULTS OF ¿250 AND 330MG/DL¿ ON THE SUBJECT METER, WHICH THE PATIENT FELT WAS INACCURATELY HIGH. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. THE PATIENT MANAGES HER DIABETES BY SELF-ADJUSTING HER INSULIN DOSES AND ADMINISTERED HER USUAL DOSE OF INSULIN, INCREASING BY 2 UNITS EVERY THREE DAYS. THE PATIENT REPORTED THAT ¿OVER TIME¿ AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED SYMPTOMS OF ¿TIRED AND WEAK¿ HOWEVER DENIED RECEIVING ANY TREATMENT. DURING THE CALL, IT WAS DETERMINED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE STRIPS HAD NOT EXPIRED HOWEVER HAD BEEN STORED INCORRECTLY. THE PRODUCT WAS REPLACED AND REQUESTED BACK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRIT

  Patient problems: Fatigue; Weakness

  MAUDE report 6610200 ↗
• InjuryMay 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER KIT WAS MISSING TEST STRIPS AND CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS THE PATIENT WAS NOT AVAILABLE WHEN MEDICAL SURVEILLANCE ATTEMPTED TO FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION RELATING TO THE COMPLAINT. THE REPORTER COULD NOT SPECIFY WHEN THE ISSUE WAS IDENTIFIED, BUT STATED THAT THE PATIENT GOT THE DEVICE ON (B)(6) 2016. THE PATIENT MANAGES HER DIABETES WITH FIXED INSULIN DOSES AND EXERCISE. THE REPORTER DETAILED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED THE PATIENT DEVELOPED SYMPTOMS OF ¿FREQUENT URINATION, DIARRHEA AND KIDNEY FAILURE¿ AND THAT ON (B)(6) 2017 THE PATIENT WAS HOSPITALIZED WHERE SHE HAD HER BLOOD GLUCOSE TESTED, BUT THE REPORTER COULD NOT SPECIFY THE RESULTS, AND THE PATIENT WAS TREATED WITH IV FLUIDS. DURING THE CALL, IT WAS DETERMINED THAT WHEN THE REPORTER WAS EDUCATED ON THE CORRECT BOX CONTENTS THERE WAS NO PRODUCT MISSING. THE PRODUCT WAS REPLACED AND REQUESTED BACK. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/

  Patient problems: Diarrhea; Renal Failure; Urinary Frequency / Polyuria

  MAUDE report 6597245 ↗