OneTouch Verio ReflectRecalls & reported problems across all models
LifeScan Europe GmbH · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 0
We found 5 models of OneTouch Verio Reflect by LifeScan Europe GmbH in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2019 and Mar 17, 2026 — classified as 32 injuries.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (26 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
Reports received per month, all models
Most reported OneTouch Verio Reflect problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings26
- Device Displays Incorrect Message4
- Device Handling Problem2
Patient problems
- Hypoglycemia8
- Shaking/Tremors8
- Diaphoresis6
- Hyperglycemia6
- Syncope/Fainting6
- Dizziness4
- Dyspnea4
- Loss of consciousness4
OneTouch Verio Reflect models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OneTouch Verio Reflect 023-927System, Test, Blood Glucose, Over The Counter12 reports
- OneTouch Verio Reflect 023-878System, Test, Blood Glucose, Over The Counter12 reports
- OneTouch Verio Reflect 024-237System, Test, Blood Glucose, Over The Counter4 reports
- OneTouch Verio Reflect 023-899System, Test, Blood Glucose, Over The Counter2 reports
- OneTouch Verio Reflect 024-369System, Test, Blood Glucose, Over The Counter2 reports
Recent OneTouch Verio Reflect adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY ERRATIC. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED BY REVIEW OF THE CALL BY A MEDICAL SURVEILLANCE SPECIALIST. THE ALLEGED ISSUE BEGAN ON (B)(6) 2025. THE PATIENT REPORTED RECEIVING READINGS OF "132MG/DL" AND "167MG/DL" WITH LESS THAN 20 MINUTES BETWEEN RESULTS WITH THE SUBJECT DEVICE. THE PATIENT ALSO REPORTED RECEIVING CONSISTENTLY HIGH READINGS COMPARED TO HER FEELINGS AND DEXCOM G6 SENSOR. THE PATIENT MANAGES THEIR DIABETES USING AN INSULIN POD WHICH DELIVERS ONE-THIRD OF A UNIT OF INSULIN PER HOUR. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INCREASED THEIR DOSE OF MEDICATION (INCREASED DOSE UNKNOWN). AFTER 3PM ON (B)(6) 2025, THE PATIENT BECAME UNCONSCIOUS. EMERGENCY SERVICES MEASURED THE PATIENT'S BLOOD GLUCOSE USING THEIR METER WHICH REVEALED THE PATIENT'S BLOOD GLUCOSE WAS "LOW". EMERGENCY SERVICES TREATED THE PATIENT WITH IV DEXTROSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECT
Patient problems: Loss of consciousness
MAUDE report 24618088 ↗InjuryMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY ERRATIC. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED BY REVIEW OF THE CALL BY A MEDICAL SURVEILLANCE SPECIALIST. THE ALLEGED ISSUE BEGAN ON (B)(6) 2025. THE PATIENT REPORTED RECEIVING READINGS OF "132MG/DL" AND "167MG/DL" WITH LESS THAN 20 MINUTES BETWEEN RESULTS WITH THE SUBJECT DEVICE. THE PATIENT ALSO REPORTED RECEIVING CONSISTENTLY HIGH READINGS COMPARED TO HER FEELINGS AND DEXCOM G6 SENSOR. THE PATIENT MANAGES THEIR DIABETES USING AN INSULIN POD WHICH DELIVERS ONE-THIRD OF A UNIT OF INSULIN PER HOUR. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INCREASED THEIR DOSE OF MEDICATION (INCREASED DOSE UNKNOWN). AFTER 3PM ON (B)(6) 2025, THE PATIENT BECAME UNCONSCIOUS. EMERGENCY SERVICES MEASURED THE PATIENT'S BLOOD GLUCOSE USING THEIR METER WHICH REVEALED THE PATIENT'S BLOOD GLUCOSE WAS "LOW". EMERGENCY SERVICES TREATED THE PATIENT WITH IV DEXTROSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECT
Patient problems: Loss of consciousness
MAUDE report 24617962 ↗InjuryMar 17, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY ERRATIC. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA), DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED BY REVIEW OF THE CALL BY A MEDICAL SURVEILLANCE SPECIALIST. THE ALLEGED ISSUE BEGAN ON (B)(6) 2025. THE PATIENT REPORTED RECEIVING READINGS OF "132MG/DL" AND "167MG/DL" WITH LESS THAN 20 MINUTES BETWEEN RESULTS, WITH THE SUBJECT DEVICE. THE PATIENT ALSO REPORTED RECEIVING CONSISTENTLY HIGH READINGS COMPARED TO HER FEELINGS AND DEXCOM G6 SENSOR. THE PATIENT MANAGES THEIR DIABETES USING AN INSULIN POD WHICH DELIVERS ONE-THIRD OF A UNIT OF INSULIN PER HOUR. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INCREASED THEIR DOSE OF MEDICATION (INCREASED DOSE UNKNOWN). AFTER 3PM ON (B)(6) 2025, THE PATIENT BECAME UNCONSCIOUS. EMERGENCY SERVICES MEASURED THE PATIENT'S BLOOD GLUCOSE USING THEIR METER WHICH REVEALED THE PATIENT'S BLOOD GLUCOSE WAS "LOW". EMERGENCY SERVICES TREATED THE PATIENT WITH IV DEXTROSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORR
Patient problems: Loss of consciousness
MAUDE report 24617810 ↗InjuryMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON 21 FEB 2026, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY ERRATIC. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED BY REVIEW OF THE CALL BY A MEDICAL SURVEILLANCE SPECIALIST. THE ALLEGED ISSUE BEGAN ON 20 NOV 2025. THE PATIENT REPORTED RECEIVING READINGS OF "132MG/DL" AND "167MG/DL" WITH LESS THAN 20 MINUTES BETWEEN RESULTS WITH THE SUBJECT DEVICE. THE PATIENT ALSO REPORTED RECEIVING CONSISTENTLY HIGH READINGS COMPARED TO HER FEELINGS AND DEXCOM G6 SENSOR. THE PATIENT MANAGES THEIR DIABETES USING AN INSULIN POD WHICH DELIVERS ONE-THIRD OF A UNIT OF INSULIN PER HOUR. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT INCREASED THEIR DOSE OF MEDICATION (INCREASED DOSE UNKNOWN). AFTER 3PM ON (B)(6) 2025, THE PATIENT BECAME UNCONSCIOUS. EMERGENCY SERVICES MEASURED THE PATIENT'S BLOOD GLUCOSE USING THEIR METER WHICH REVEALED THE PATIENT'S BLOOD GLUCOSE WAS "LOW". EMERGENCY SERVICES TREATED THE PATIENT WITH IV DEXTROSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECT
Patient problems: Loss of consciousness
MAUDE report 24597635 ↗InjuryJun 20, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS DISPLAYING ERROR 2, 4 AND 6 MESSAGES. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE/TIME APPROXIMATELY ONE AND A HALF WEEKS BEFORE THE END OF (B)(6) 2025. THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTED INSULIN (LANTUS AND HUMALOG, DOSES NOT SPECIFIED, TAKEN DAILY) AND THE ADVISED THAT IN RESPONSE TO THE ALLEGED ISSUE, THEY STOPPED ADMINISTERING THEIR MEDICATION. THE PATIENT ALLEGED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE(S) BEGAN, THEY ¿FELT HIGH GLUCOSE¿, THAT THEY ¿PASSED OUT AND HAD DIABETIC KETOACIDOSIS¿. THE PATIENT ADVISED THAT THEY CONTACTED EMERGENCY MEDICAL SERVICES (EMS) WHO REPORTEDLY ATTENDED AND SUBSEQUENTLY ADMINISTERED ¿INSULIN DRIP, SODIUM, WATER AND POTASSIUM¿. THE CUSTOMER WAS UNABLE AND/OR UNWILLING TO CONFIRM IF THEIR BLOOD GLUCOSE WAS MEASURED AT THE TIME OF EMS ARRIVAL. AT THE TIME OF TROUBLESHOOTING, THE CCA ESTABLISHED THA
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Syncope/Fainting
MAUDE report 22296367 ↗InjuryJun 20, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS DISPLAYING ERROR 2, 4 AND 6 MESSAGES. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE/TIME APPROXIMATELY ONE AND A HALF WEEKS BEFORE THE END OF (B)(6) 2025. THE PATIENT MANAGES THEIR DIABETES WITH SELF-ADJUSTED INSULIN (LANTUS AND HUMALOG, DOSES NOT SPECIFIED, TAKEN DAILY) AND THE ADVISED THAT IN RESPONSE TO THE ALLEGED ISSUE, THEY STOPPED ADMINISTERING THEIR MEDICATION. THE PATIENT ALLEGED THAT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE(S) BEGAN, THEY ¿FELT HIGH GLUCOSE¿, THAT THEY ¿PASSED OUT AND HAD DIABETIC KETOACIDOSIS¿. THE PATIENT ADVISED THAT THEY CONTACTED EMERGENCY MEDICAL SERVICES (EMS) WHO REPORTEDLY ATTENDED AND SUBSEQUENTLY ADMINISTERED ¿INSULIN DRIP, SODIUM, WATER AND POTASSIUM¿. THE CUSTOMER WAS UNABLE AND/OR UNWILLING TO CONFIRM IF THEIR BLOOD GLUCOSE WAS MEASURED AT THE TIME OF EMS ARRIVAL. AT THE TIME OF TROUBLESHOOTING, THE CCA ESTABLISHED THA
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Syncope/Fainting
MAUDE report 22296269 ↗InjuryJun 19, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS DISPLAYING AN ¿ERROR 2¿ (WITH SUB-ERROR CODE 2) MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2025, AND THEY WERE UNABLE TO MEASURE THEIR BLOOD GLUCOSE LEVELS. THEY DID NOT TAKE ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. ON (B)(6), 2025, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THEY DEVELOPED SYMPTOMS OF FEELING ¿VERY WEAK AND ALMOST LOSING CONSCIOUSNESS¿. EMERGENCY MEDICAL SERVICES WERE CONTACTED FOR ASSISTANCE. WHEN THE PARAMEDICS ARRIVED, THEY FOUND THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE ¿VERY LOW¿ (EXACT READING NOT PROVIDED). THE PATIENT STATED THAT THEY WERE TAKEN TO HOSPITAL WHEY THERE RECEIVED TREATMENT OF A DEXTROSE TABLET AND UNSPECIFIED MEDICATION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THE PATIENT THOUGH A TEST HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. REPLACEMEN
Patient problems: Hypoglycemia; Presyncope
MAUDE report 22290540 ↗InjuryJun 18, 2025Device Displays Incorrect Message; Device Displays Incorrect Message
ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS DISPLAYING AN ¿ERROR 2¿ (WITH SUB-ERROR CODE 2) MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2025, AND THEY WERE UNABLE TO MEASURE THEIR BLOOD GLUCOSE LEVELS. THEY DID NOT TAKE ANY ACTION REGARDING THEIR USUAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. ON (B)(6) 2025, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THEY DEVELOPED SYMPTOMS OF FEELING ¿VERY WEAK AND ALMOST LOSING CONSCIOUSNESS¿. EMERGENCY MEDICAL SERVICES WERE CONTACTED FOR ASSISTANCE. WHEN THE PARAMEDICS ARRIVED, THEY FOUND THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE ¿VERY LOW¿ (EXACT READING NOT PROVIDED). THE PATIENT STATED THAT THEY WERE TAKEN TO HOSPITAL WHEY THERE RECEIVED TREATMENT OF A DEXTROSE TABLET AND UNSPECIFIED MEDICATION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THE PATIENT THOUGH A TEST HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. REPLACEMENT
Patient problems: Hypoglycemia; Presyncope
MAUDE report 22288608 ↗InjuryAug 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON AUGUST 7, 2024, A PHARMACIST CONTACTED LIFESCAN (LFS) FRANCE ON BEHALF OF THE LAY USER/PATIENT, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE CONTACTED FOR ADDITIONAL INFORMATION. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. THE REPORTER CLAIMED THE PATIENT OBTAINED AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿242 MG/DL¿ WITH THE SUBJECT METER. IN RESPONSE TO THE ELEVATED READING, THE REPORTER CLAIMED THE PATIENT ADMINISTERED AN INCREASED DOSE OF INSULIN AND AS A RESULT WAS RUSHED TO HOSPITAL AND WAS HOSPITALIZED. THE REPORTER WAS UNABLE TO CONFIRM THE SYMPTOMS EXPERIENCED NOR THE TREATMENT RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE REPORTER WAS UNABLE TO PROVIDE ANY INFORMATION ABOUT THE PATIENT¿S TESTING TECHNIQUE OR CONDITION OF THE TEST STRIPS. REPLACEMENT PRODUCTS WERE PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY REQUIRED HOSPITALIZATION AFTER TAKING EXTRA INSULIN BASED ON AN ALLEGED INACCURATE HIGH RESULT OBTAINED WITH THE SUBJECT
Patient problems: Insufficient Information
MAUDE report 19988087 ↗InjuryAug 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2024, A PHARMACIST CONTACTED LIFESCAN (LFS) FRANCE ON BEHALF OF THE LAY USER/PATIENT, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE PATIENT COULD NOT BE CONTACTED FOR ADDITIONAL INFORMATION. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. THE REPORTER CLAIMED THE PATIENT OBTAINED AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿242 MG/DL¿ WITH THE SUBJECT METER. IN RESPONSE TO THE ELEVATED READING, THE REPORTER CLAIMED THE PATIENT ADMINISTERED AN INCREASED DOSE OF INSULIN AND AS A RESULT WAS RUSHED TO HOSPITAL AND WAS HOSPITALIZED. THE REPORTER WAS UNABLE TO CONFIRM THE SYMPTOMS EXPERIENCED NOR THE TREATMENT RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE REPORTER WAS UNABLE TO PROVIDE ANY INFORMATION ABOUT THE PATIENT¿S TESTING TECHNIQUE OR CONDITION OF THE TEST STRIPS. REPLACEMENT PRODUCTS WERE PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY REQUIRED HOSPITALIZATION AFTER TAKING EXTRA INSULIN BASED ON AN ALLEGED INACCURATE HIGH RESULT OBTAINED WITH THE SUBJECT ME
Patient problems: Insufficient Information
MAUDE report 19988085 ↗InjurySep 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON SEPTEMBER 15, 2023, THE LAY USER/PATIENT¿S RELATIVE CONTACTED LIFESCAN (LFS) ITALY, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER READ INACCURATELY LOW COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS AND COMPARED TO AN EMERGENCY MEDICAL SERVICE METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT ON (B)(6) 2023, AT 10:00 AM, THE PATIENT MEASURED HIS BLOOD GLUCOSE WITH THE SUBJECT METER IN RESPONSE TO SYMPTOMS OF ¿NOT FEELING WELL¿ AND OBTAINED AN ALLEGED LOW RESULT OF ¿40 MG/DL¿. THE REPORTER WAS UNABLE TO PROVIDE INFORMATION ON THE SPECIFIC SYMPTOMS FELT AT THAT TIME. THE REPORTER MENTIONED THAT THE PATIENT IS ASSISTED DAILY BY A CARER. THE REPORTER ADVISED THAT THE PATIENT PERFORMS BLOOD GLUCOSE MONITORING ONCE A DAY, 6 OR 7 TIMES A WEEK AND THAT HE TAKES ORAL THERAPY (TYPE/DOSE NOT REPORTED) AND A ONCE DAILY DOSE OF INSULIN TO MANAGE HIS DIABETES. DURING THE FOLLOW-UP CALL, THE REPORTER CLAIMED THAT IN THE DAYS PRIOR TO THE ALLEGED ISSUE, THE PATIENT WAS RECEIVING BLOOD GLUCOSE RESULTS OF AROUND ¿380 TO 400 MG/DL¿. AS A RESULT OF THE ALLEGED
Patient problems: Alteration in Body Temperature; Apnea; Dehydration; Hyperglycemia; Muscle Weakness/Atrophy; Pallor; Polydipsia; Syncope/Fainting
MAUDE report 17840507 ↗InjurySep 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, THE LAY USER/PATIENT¿S RELATIVE CONTACTED LIFESCAN (LFS) ITALY, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER READ INACCURATELY LOW COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS AND COMPARED TO AN EMERGENCY MEDICAL SERVICE METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT ON (B)(6) 2023, AT 10:00 AM, THE PATIENT MEASURED HIS BLOOD GLUCOSE WITH THE SUBJECT METER IN RESPONSE TO SYMPTOMS OF ¿NOT FEELING WELL¿ AND OBTAINED AN ALLEGED LOW RESULT OF ¿40 MG/DL¿. THE REPORTER WAS UNABLE TO PROVIDE INFORMATION ON THE SPECIFIC SYMPTOMS FELT AT THAT TIME. THE REPORTER MENTIONED THAT THE PATIENT IS ASSISTED DAILY BY A CARER. THE REPORTER ADVISED THAT THE PATIENT PERFORMS BLOOD GLUCOSE MONITORING ONCE A DAY, 6 OR 7 TIMES A WEEK AND THAT HE TAKES ORAL THERAPY (TYPE/DOSE NOT REPORTED) AND A ONCE DAILY DOSE OF INSULIN TO MANAGE HIS DIABETES. DURING THE FOLLOW-UP CALL, THE REPORTER CLAIMED THAT IN THE DAYS PRIOR TO THE ALLEGED ISSUE, THE PATIENT WAS RECEIVING BLOOD GLUCOSE RESULTS OF AROUND ¿380 TO 400 MG/DL¿. AS A RESULT OF THE ALLEGED INACCUR
Patient problems: Alteration in Body Temperature; Apnea; Dehydration; Hyperglycemia; Muscle Weakness/Atrophy; Pallor; Polydipsia; Syncope/Fainting
MAUDE report 17840499 ↗InjuryMar 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, THE REPORTER (A SALES REPRESENTATIVE) OF THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) SPAIN ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER READ INACCURATELY LOW COMPARED TO A LABORATORY TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR FOLLOW-UP QUESTIONS. THE REPORTER DID NOT SPECIFY WHEN THE ALLEGED ISSUE STARTED. THE REPORTER STATED THAT THE PATIENT RECEIVED A LOW BLOOD GLUCOSE READING OF ¿20/30 MG/DL¿ ON THE SUBJECT METER. THE REPORTER DID NOT HAVE INFORMATION ABOUT HOW THE PATIENT USUALLY MANAGES THEIR DIABETES NOR WHETHER THE PATIENT TOOK ANY ACTIONS BASED ON THE LOW READING RECEIVED ON THE SUBJECT METER. AT AN UNSPECIFIED TIME, THE PATIENT STARTED TO FEEL ¿DIZZY¿ AND WAS BROUGHT TO THE HOSPITAL FOR UNSPECIFIED TREATMENT. THE REPORTER INFORMED THE CCA THAT A LABORATORY TEST WAS DONE AT THE HOSPITAL AND A BLOOD GLUCOSE READING OF ¿300 MG/DL¿ WAS OBTAINED. DURING TROUBLESHOOTING, THE CCA ESTABLISHED THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. THE CCA REPLACED THE PRODUCTS. MEDICAL SURV
Patient problems: Dizziness
MAUDE report 16483144 ↗InjuryMar 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2023, THE REPORTER (A SALES REPRESENTATIVE) OF THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) SPAIN ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER READ INACCURATELY LOW COMPARED TO A LABORATORY TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL, SINCE THE PATIENT WAS UNABLE TO BE REACHED BY PHONE FOR FOLLOW-UP QUESTIONS. THE REPORTER DID NOT SPECIFY WHEN THE ALLEGED ISSUE STARTED. THE REPORTER STATED THAT THE PATIENT RECEIVED A LOW BLOOD GLUCOSE READING OF ¿20/30 MG/DL¿ ON THE SUBJECT METER. THE REPORTER DID NOT HAVE INFORMATION ABOUT HOW THE PATIENT USUALLY MANAGES THEIR DIABETES NOR WHETHER THE PATIENT TOOK ANY ACTIONS BASED ON THE LOW READING RECEIVED ON THE SUBJECT METER. AT AN UNSPECIFIED TIME, THE PATIENT STARTED TO FEEL ¿DIZZY¿ AND WAS BROUGHT TO THE HOSPITAL FOR UNSPECIFIED TREATMENT. THE REPORTER INFORMED THE CCA THAT A LABORATORY TEST WAS DONE AT THE HOSPITAL AND A BLOOD GLUCOSE READING OF ¿300 MG/DL¿ WAS OBTAINED. DURING TROUBLESHOOTING, THE CCA ESTABLISHED THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. THE CCA REPLACED THE PRODUCTS. MEDICAL SURV
Patient problems: Dizziness
MAUDE report 16483138 ↗InjuryMar 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON FEBRUARY 21, 2023, THE LAY USER/PATIENT¿S DAUGHTER CONTACTED LIFESCAN (LFS), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER WAS UNWILLING TO PROVIDE FURTHER INFORMATION DURING A FOLLOW-UP CALL. THE REPORTER STATED THE PATIENT HAD RECENTLY STARTED RECEIVING WHAT SHE FELT WERE INACCURATE HIGH READINGS OF ¿OVER 300 MG/DL¿ WITH THE SUBJECT METER. THE REPORTER STATED THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (DIABETEX 500 MG, ONLY ONE TABLET A DAY BECAUSE SHE IS HIGHLY ALLERGIC). THE REPORTER ALSO MENTIONED THE PATIENT IS ON BETA BLOCKERS. THE REPORTER STATED THAT ON (B)(6) 2023, BETWEEN 5:00 PM AND 6:00 PM, THE PATIENT BECAME SCARED WHEN SHE RECEIVED A READING OF ¿317 MG/DL¿ WITH THE SUBJECT METER AND TOOK ONE DIABETEX 500 MG TABLET IN RESPONSE. AS A RESULT, THE REPORTER STATED THE PATIENT EXPERIENCED HYPOGLYCEMIA WITH SYMPTOMS OF ¿ALMOST BECAME UNCONSCIOUS, DIZZY, POWERLESS AND PALE FACE¿ ON (B)(6) 2023, BETWEEN 5:00 PM AND 6:00 PM. THE REPORTER STATED THE PATIENT WAS IMMEDIATELY TAKEN TO HOSPITAL BY AMBULANCE AND WAS GIVEN ¿NITR
Patient problems: Dizziness; Extreme Exhaustion; Hypoglycemia; Pallor; Presyncope
MAUDE report 16475121 ↗
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 16, 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