OneTouch Ultra2Recalls & reported problems across all models
LifeScan Europe GmbH · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 2 models of OneTouch Ultra2 by LifeScan Europe GmbH in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between May 30, 2017 and Sep 16, 2022 — classified as 21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported OneTouch Ultra2 problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings11
- Loss of Power3
- Adverse Event Without Identified Device or Use Problem2
- Device Handling Problem2
- Incorrect Or Inadequate Test Results2
- Component Missing1
- Device Alarm System1
Patient problems
- Diaphoresis6
- Urinary Frequency / Polyuria5
- Dizziness4
- Fatigue4
- Anxiety2
- High Blood Pressure/ Hypertension2
- Hyperglycemia2
- Increased Appetite2
OneTouch Ultra2 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OneTouch Ultra2 021-098SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER15 reports
- OneTouch Ultra2 021-100GLUCOSE OXIDASE, GLUCOSE7 reports
Recent OneTouch Ultra2 adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryApr 18, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results
ON (B)(6) 2018, THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT HIS WIFE¿S ONETOUCH ULTRA 2 METER WAS READING INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER ALLEGED THAT, THEY FIRST BECAME AWARE OF THE PRODUCT ISSUE ON (B)(6) 2018, AT 6 PM, WHEN HIS WIFE OBTAINED BLOOD GLUCOSE READINGS OF ¿170 AND 567 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. THE REPORTER STATED THAT HIS WIFE MANAGES HER DIABETES USING INSULIN (SELF-ADJUSTER), AND THAT SHE MADE NO CHANGES TO HER NORMAL DIABETES MANAGEMENT, IN RESPONSE TO THE ALLEGED INACCURATE READINGS. THE REPORTER STATED THAT 15 MINS PRIOR TO THE METER ISSUE, THE PATIENT HAD DEVELOPED SYMPTOMS OF ¿NAUSEA¿. THE REPORTER STATED THAT HIS WIFE ATTENDED THE HOSPITAL, AND WAS TREATED BY A HEALTH CARE PROFESSIONAL, WITH ¿10 SHOTS OF HUMALOG AND LANTUS INSULIN¿, AT 6.10 ¿ 6.15 PM ON THE SAME DAY. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE CORRECT TESTING STE
Patient problems: Nausea
MAUDE report 7439111 ↗InjuryMar 8, 2018Device Alarm System; Device Alarm System
ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA2 METER CONTINUED TO DISPLAY THE APPLY SAMPLE ICON INSTEAD OF COUNTING DOWN AND PROVIDING A BLOOD GLUCOSE RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE BEGAN 3 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH ¿LECIMITRIL 2.5¿ AND CLAIMED SHE TOOK HER USUAL DOSE OF MEDICATION ON (B)(6) 2018 AT 4:00 PM IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿LIGHTHEADEDNESS, FELT ILL, OFF BALANCE, DID NOT FEEL GOOD¿ AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. IT WAS NOTED THAT THE CORRECT STRIPS WERE BEING USED FOR TESTING AND THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CSR NOTED THE PATIENT DID NOT HAVE TESTING SUPPLIES AVAILABLE TO TEST THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PAT
Patient problems: Dizziness; Malaise; Vertigo
MAUDE report 7322870 ↗
Other LifeScan Europe GmbH products
All LifeScan Europe GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page