OneTouch Verio Flex 023-271Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,703 adverse event reports that list this exact device (DI 00353885010986), received between Nov 18, 2016 and Mar 23, 2026 — classified as 623 injuries, 3,080 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1,409 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 3,703 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Device Displays Incorrect Message

  ON FEBRUARY 26, 2026, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WAS DISPLAYING AN ¿ERROR 2¿ MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE ATTEMPTS TO REACH THE REPORTER FOR FURTHER INFORMATION WERE UNSUCCESSFUL. THE REPORTER STATED THAT ON FEBRUARY 25, 2026, AT 1:30 AM, THE PATIENT WAS SLEEPING AND WHEN SHE ATTEMPTED TO WAKE HIM, HE WAS ¿UNRESPONSIVE¿, AND AN ¿ERROR 2¿ MESSAGE APPEARED WHEN ATTEMPTING TO TEST HIS BLOOD GLUCOSE WITH THE SUBJECT METER. THE REPORTER STATED THAT SHE CALLED EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. WHEN EMS ARRIVED, THE REPORTER CLAIMED THAT THEY TESTED THE PATIENT¿S BLOOD GLUCOSE ON THE EMS METER (UNSPECIFIED RESULT) AND PROVIDED UNSPECIFIED TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THROUGH RESOLVING THE ISSUE HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. A REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR A POSSIB

  Patient problems: Loss of consciousness

  MAUDE report 24662923 ↗
• InjuryMar 23, 2026Device Displays Incorrect Message

  ON (B)(6) 2026, THE LAY USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WAS DISPLAYING AN ¿ERROR 2¿ MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE ATTEMPTS TO REACH THE REPORTER FOR FURTHER INFORMATION WERE UNSUCCESSFUL. THE REPORTER STATED THAT ON (B)(6) 2026, AT 1:30 AM, THE PATIENT WAS SLEEPING AND WHEN SHE ATTEMPTED TO WAKE HIM, HE WAS ¿UNRESPONSIVE¿, AND AN ¿ERROR 2¿ MESSAGE APPEARED WHEN ATTEMPTING TO TEST HIS BLOOD GLUCOSE WITH THE SUBJECT METER. THE REPORTER STATED THAT SHE CALLED EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. WHEN EMS ARRIVED, THE REPORTER CLAIMED THAT THEY TESTED THE PATIENT¿S BLOOD GLUCOSE ON THE EMS METER (UNSPECIFIED RESULT) AND PROVIDED UNSPECIFIED TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THROUGH RESOLVING THE ISSUE HOWEVER THE ALLEGED ISSUE COULD NOT BE RESOLVED. A REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR A POSSIBLE ACUTE COM

  Patient problems: Loss of consciousness

  MAUDE report 24662915 ↗
• InjuryApr 18, 2025Power Problem; Power Problem

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO METER WOULD NOT TURN ON. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST LISTENED TO THE CALL RECORDING. THE PATIENT COULD NOT BE REACHED FOR FOLLOW-UP. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE/TIME APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (LANTUS INSULIN LONG ACTING 10 UNITS PER DAY AND HUMALOG, SELF-ADJUSTED 8 ¿ 10 UNITS 3 TIMES PER DAY) AND THEY ADVISED THAT THEY CONTINUED TO ADMINISTER THEIR USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT ALLEGED THAT AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THEY ¿LOST CONSCIOUSNESS¿, WHICH THEY ATTRIBUTED TO NOT BEING ABLE TO OBTAIN A GLUCOSE READING. THE PATIENT REPORTED DURING THE CALL THAT THEY CALLED AN AMBULANCE AND WERE TAKEN TO HOSPITAL WHERE THEY RECEIVED MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE; HOWEVER, THEY WERE UNABLE AND/OR UNWILLING TO PROVID

  Patient problems: Loss of consciousness

  MAUDE report 21863604 ↗
• InjuryApr 18, 2025Power Problem; Power Problem

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO METER WOULD NOT TURN ON. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST LISTENED TO THE CALL RECORDING. THE PATIENT COULD NOT BE REACHED FOR FOLLOW-UP. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT AN UNSPECIFIED DATE/TIME APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (LANTUS INSULIN LONG ACTING 10 UNITS PER DAY AND HUMALOG, SELF-ADJUSTED 8 ¿ 10 UNITS 3 TIMES PER DAY) AND THEY ADVISED THAT THEY CONTINUED TO ADMINISTER THEIR USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT ALLEGED THAT AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE BEGAN, THEY ¿LOST CONSCIOUSNESS¿, WHICH THEY ATTRIBUTED TO NOT BEING ABLE TO OBTAIN A GLUCOSE READING. THE PATIENT REPORTED DURING THE CALL THAT THEY CALLED AN AMBULANCE AND WERE TAKEN TO HOSPITAL WHERE THEY RECEIVED MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE; HOWEVER, THEY WERE UNABLE AND/OR UNWILLING TO PROVID

  Patient problems: Loss of consciousness

  MAUDE report 21863562 ↗
• InjuryMar 26, 2025Device Alarm System; Device Displays Incorrect Message; Power Problem; Device Alarm System; Device Displays Incorrect Message; Power Problem

  ON (B)(6) 2025, THE REPORTER OF THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER DISPLAYED AN UNKNOWN ERROR MESSAGE, CONTINUED DISPLAYING ¿APPLY BLOOD¿ AFTER APPLYING A BLOOD SAMPLE AND POWERED OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION SINCE THE PATIENT COULD NOT BE REACHED BY PHONE FOR FOLLOW-UP QUESTIONS. THE REPORTER ALLEGED THAT THE ISSUES OCCURRED ON (B)(6) 2025, AT AN UNSPECIFIED TIME. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION (LANTUS INSULIN 19 UNITS AND GLIPIZIDE ¿ 1 TABLET TWICE A DAY) AND THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED ISSUES. THAT SAME DAY, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT WAS ¿SHAKING, HAD A CONVULSION, WAS DIZZY AND DID NOT KNOW WHERE THEY WERE¿. THAT SAME DAY, AROUND 8 O¿CLOCK (AM OR PM WAS NOT SPECIFIED), THE PARAMEDICS WERE CALLED AND A BLOOD GLUCOSE READING OF ¿40 MG/DL¿ WAS OBTAINED ON AN EMERGENCY MEDICAL SERVICES (EMS) METER INDICATING THE PATIENT WAS ¿HYPOGLYCEMIC¿. THE REPORTER IS UNSURE WHETHER THE PARAMEDICS PROVIDED THE PATIENT WITH ANY T

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Dizziness; Hypoglycemia; Shaking/Tremors

  MAUDE report 21704315 ↗
• InjuryMar 26, 2025Device Alarm System; Device Displays Incorrect Message; Power Problem; Device Alarm System; Device Displays Incorrect Message; Power Problem

  ON (B)(6) 2025, THE REPORTER OF THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER DISPLAYED AN UNKNOWN ERROR MESSAGE, CONTINUED DISPLAYING ¿APPLY BLOOD¿ AFTER APPLYING A BLOOD SAMPLE AND POWERED OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION SINCE THE PATIENT COULD NOT BE REACHED BY PHONE FOR FOLLOW-UP QUESTIONS. THE REPORTER ALLEGED THAT THE ISSUES OCCURRED ON (B)(6) 2025, AT AN UNSPECIFIED TIME. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION (LANTUS INSULIN 19 UNITS AND GLIPIZIDE ¿ 1 TABLET TWICE A DAY) AND THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED ISSUES. THAT SAME DAY, AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT WAS ¿SHAKING, HAD A CONVULSION, WAS DIZZY AND DID NOT KNOW WHERE THEY WERE¿. THAT SAME DAY, AROUND 8 O¿CLOCK (AM OR PM WAS NOT SPECIFIED), THE PARAMEDICS WERE CALLED AND A BLOOD GLUCOSE READING OF ¿40 MG/DL¿ WAS OBTAINED ON AN EMERGENCY MEDICAL SERVICES (EMS) METER INDICATING THE PATIENT WAS ¿HYPOGLYCEMIC¿. THE REPORTER IS UNSURE WHETHER THE PARAMEDICS PROVIDED THE PATIENT WITH ANY T

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Dizziness; Hypoglycemia; Shaking/Tremors

  MAUDE report 21704314 ↗
• InjuryJan 16, 2025Power Problem; Power Problem

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER WAS POWERING OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING REVIEW OF THE CALL RECORDING. THE PATIENT ALLEGED THAT THE ISSUE STARTED MORE THAN A WEEK PRIOR TO THE CALL WITH LFS, AT AN UNSPECIFIED TIME. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION (JARDIANCE INSULIN ¿ 50 MG AT NIGHT AND METFORMIN ¿ 2 PILLS IN THE MORNING AND AT NIGHT). THE PATIENT MENTIONED THAT THEY WERE FASTING FOR 4 DAYS ON A LIQUID DIET AND INDICATED THAT THIS MUST HAVE LOWERED THEIR BLOOD SUGAR. IN THE MORNING OF (B)(6) 2024, THEY WENT TO THE HOSPITAL FOR AN UNRELATED PROCEDURE. THE PATIENT CLAIMED THAT THE NURSE CHECKED THEIR BLOOD SUGAR ON A HOSPITAL DEVICE AND OBTAINED A READING OF ¿60 MG/DL¿. THE PATIENT STATED THAT THE NURSE ADDED SOME SUGAR WATER IN THEIR IV TO BRING THE SUGAR UP. THE PATIENT INITIALLY DENIED DEVELOPING SYMPTOMS AND MENTIONED THAT THEY WERE NOT AWARE OF THE LOWER BLOOD SUGAR LEVELS. IT WAS NOTED THAT, LATER IN THE C

  Patient problems: Headache; Hypoglycemia

  MAUDE report 21175398 ↗
• InjuryJan 16, 2025Power Problem; Power Problem

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER WAS POWERING OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING REVIEW OF THE CALL RECORDING. THE PATIENT ALLEGED THAT THE ISSUE STARTED MORE THAN A WEEK PRIOR TO THE CALL WITH LFS, AT AN UNSPECIFIED TIME. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION (JARDIANCE INSULIN ¿ 50 MG AT NIGHT AND METFORMIN ¿ 2 PILLS IN THE MORNING AND AT NIGHT). THE PATIENT MENTIONED THAT THEY WERE FASTING FOR 4 DAYS ON A LIQUID DIET AND INDICATED THAT THIS MUST HAVE LOWERED THEIR BLOOD SUGAR. IN THE MORNING OF (B)(6) 2024, THEY WENT TO THE HOSPITAL FOR AN UNRELATED PROCEDURE. THE PATIENT CLAIMED THAT THE NURSE CHECKED THEIR BLOOD SUGAR ON A HOSPITAL DEVICE AND OBTAINED A READING OF ¿60 MG/DL¿. THE PATIENT STATED THAT THE NURSE ADDED SOME SUGAR WATER IN THEIR IV TO BRING THE SUGAR UP. THE PATIENT INITIALLY DENIED DEVELOPING SYMPTOMS AND MENTIONED THAT THEY WERE NOT AWARE OF THE LOWER BLOOD SUGAR LEVELS. IT WAS NOTED THAT, LATER IN THE C

  Patient problems: Headache; Hypoglycemia

  MAUDE report 21175397 ↗
• InjuryJan 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON DECEMBER 20, 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER READ INACCURATELY LOW COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE CONTACT INFORMATION FOR THE PATIENT WAS NOT PROVIDED TO OBTAIN FURTHER INFORMATION. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. NO SPECIFIC READINGS WERE PROVIDED. IT WAS NOT REPORTED IF THE PATIENT TAKES MEDICATION TO MANAGE THEIR DIABETES OR IF THEY MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. IT WAS NOT REPORTED IF THE PATIENT DEVELOPED ANY SYMPTOMS, HOWEVER, THE REPORTER MENTIONED THAT AT AN UNSPECIFIED DATE AND TIME THE EMERGENCY MEDICAL SERVICES (EMS) WERE NOTIFIED FOR ASSISTANCE SINCE THE RESULT ON THE SUBJECT METER WAS ¿TOO LOW¿. WHEN EMS ARRIVED, THE REPORTER INDICATED THAT THE PATIENT RECEIVED A BLOOD GLUCOSE TEST AND UNSPECIFIED TREATMENT. THE REPORTER DECLINED TO PROVIDE FURTHER INFORMATION. THE REPORTER DECLINED TO COMPLETE THE TROUBLESHOOTING PROCESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE

  Patient problems: Insufficient Information

  MAUDE report 21108196 ↗
• InjuryJan 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON DECEMBER 20, 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER READ INACCURATELY LOW COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE CONTACT INFORMATION FOR THE PATIENT WAS NOT PROVIDED TO OBTAIN FURTHER INFORMATION. IT WAS NOT REPORTED WHEN THE ALLEGED METER INACCURACY BEGAN. NO SPECIFIC READINGS WERE PROVIDED. IT WAS NOT REPORTED IF THE PATIENT TAKES MEDICATION TO MANAGE THEIR DIABETES OR IF THEY MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. IT WAS NOT REPORTED IF THE PATIENT DEVELOPED ANY SYMPTOMS, HOWEVER, THE REPORTER MENTIONED THAT AT AN UNSPECIFIED DATE AND TIME THE EMERGENCY MEDICAL SERVICES (EMS) WERE NOTIFIED FOR ASSISTANCE SINCE THE RESULT ON THE SUBJECT METER WAS ¿TOO LOW¿. WHEN EMS ARRIVED, THE REPORTER INDICATED THAT THE PATIENT RECEIVED A BLOOD GLUCOSE TEST AND UNSPECIFIED TREATMENT. THE REPORTER DECLINED TO PROVIDE FURTHER INFORMATION. THE REPORTER DECLINED TO COMPLETE THE TROUBLESHOOTING PROCESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE

  Patient problems: Insufficient Information

  MAUDE report 21108193 ↗
• InjuryNov 1, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WAS DISPLAYING AN ¿ERROR 5¿ MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT ON (B)(6) 2024, BETWEEN 6:00 PM AND 6:30 PM, THE PATIENT WAS FEELING ¿LOOPY¿. THE PATIENT DRANK ORANGE JUICE AND ATE PEANUT BUTTER THEN ATTEMPTED TO TEST HER BLOOD GLUCOSE AT 6:30 PM BUT THE ALLEGED ERROR MESSAGE BEGAN PROMPTING. THE EMERGENCY MEDICAL SERVICES (EMS) WERE REPORTEDLY NOTIFIED FOR ASSISTANCE. THE REPORTER CLAIMED THAT WHEN EMS ARRIVED AT 7:00 PM, THEY TESTED THE PATIENT¿S BLOOD GLUCOSE ON THE EMS METER AND OBTAINED A READING OF ¿42 MG/DL¿ AND TREATED HER WITH INTRAVENOUS FLUIDS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THROUGH RESOLVING ISSUE AND THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED METER ISSUE B

  Patient problems: Hypoglycemia

  MAUDE report 20593768 ↗
• InjuryNov 1, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WAS DISPLAYING AN ¿ERROR 5¿ MESSAGE DURING TESTING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT ON (B)(6) 2024, BETWEEN 6:00 PM AND 6:30 PM, THE PATIENT WAS FEELING ¿LOOPY¿. THE PATIENT DRANK ORANGE JUICE AND ATE PEANUT BUTTER THEN ATTEMPTED TO TEST HER BLOOD GLUCOSE AT 6:30 PM BUT THE ALLEGED ERROR MESSAGE BEGAN PROMPTING. THE EMERGENCY MEDICAL SERVICES (EMS) WERE REPORTEDLY NOTIFIED FOR ASSISTANCE. THE REPORTER CLAIMED THAT WHEN EMS ARRIVED AT 7:00 PM, THEY TESTED THE PATIENT¿S BLOOD GLUCOSE ON THE EMS METER AND OBTAINED A READING OF ¿42 MG/DL¿ AND TREATED HER WITH INTRAVENOUS FLUIDS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA WALKED THROUGH RESOLVING ISSUE AND THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER THE ALLEGED METER ISSUE B

  Patient problems: Hypoglycemia

  MAUDE report 20593767 ↗
• InjuryOct 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6)2024, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION OF THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2024, AT AN UNSPECIFIED TIME. THE PATIENT RECEIVED A BLOOD GLUCOSE READING OF ¿OVER 300 MG/DL¿ ON THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (HUMALOG 3CC DAILY AND LANTUS, SELF-ADJUSTABLE DOSE DEPENDING ON READING) AND STATED THAT THEY TOOK AN ADDITIONAL SHOT OF HUMALOG 3CC IN RESPONSE TO THE HIGH READING FROM THE SUBJECT METER. THE PATIENT INDICATED THAT ANOTHER READING WAS OBTAINED AFTER, HOWEVER THE READING REMAINED THE SAME. THAT SAME DAY, AT AN UNSPECIFIED TIME AFTER THE INCREASE OF MEDICATION, THE PATIENT STARTED DEVELOPING SYMPTOMS OF ¿DRY EYES, DIZZINESS, UNCONSCIOUS AND FAINTED¿. THE PATIENT¿S DAUGHTER AND WIFE CALLED THE AMBULANCE AND A READING OF ¿21 MG/DL¿ WAS OBTAINED ON AN ER METER. THE PATIENT CLAIMED THEY WERE TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH VITAMIN BAGS, FOOD AND LIQUIDS THAT SAME D

  Patient problems: Dizziness; Dry Eye(s); Loss of consciousness; Syncope/Fainting

  MAUDE report 20529152 ↗
• InjuryOct 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON OCTOBER 8, 2024, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION OF THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2024, AT AN UNSPECIFIED TIME. THE PATIENT RECEIVED A BLOOD GLUCOSE READING OF ¿OVER 300 MG/DL¿ ON THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (HUMALOG 3CC DAILY AND LANTUS, SELF-ADJUSTABLE DOSE DEPENDING ON READING) AND STATED THAT THEY TOOK AN ADDITIONAL SHOT OF HUMALOG 3CC IN RESPONSE TO THE HIGH READING FROM THE SUBJECT METER. THE PATIENT INDICATED THAT ANOTHER READING WAS OBTAINED AFTER, HOWEVER THE READING REMAINED THE SAME. THAT SAME DAY, AT AN UNSPECIFIED TIME AFTER THE INCREASE OF MEDICATION, THE PATIENT STARTED DEVELOPING SYMPTOMS OF ¿DRY EYES, DIZZINESS, UNCONSCIOUS AND FAINTED¿. THE PATIENT¿S DAUGHTER AND WIFE CALLED THE AMBULANCE AND A READING OF ¿21 MG/DL¿ WAS OBTAINED ON AN ER METER. THE PATIENT CLAIMED THEY WERE TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH VITAMIN BAGS, FOOD AND LIQUIDS THAT S

  Patient problems: Dizziness; Dry Eye(s); Loss of consciousness; Syncope/Fainting

  MAUDE report 20528709 ↗
• InjuryOct 17, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON (B)(6) 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WAS ¿TESTING IN SETTINGS MODE¿. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL SINCE THE REPORTER COULD NOT BE REACHED WHEN THE CCA ATTEMPTED TO FOLLOW UP WITH THEM TO OBTAIN ADDITIONAL INFORMATION. THE REPORTER WAS UNABLE AND/OR UNWILLING TO ADVISE WHEN THE ALLEGED ISSUE FIRST BEGAN. IT IS NOT KNOWN WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE THEIR DIABETES OR IF THEY MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE CCA WALKED THE REPORTER THROUGH THE CORRECT TESTING PROCEDURE AND NOTED THAT ALTHOUGH THE APPLY SAMPLE ICON APPEARED ON THE SUBJECT METER, THE REPORTER WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING AS THEY WERE ¿NOT GETTING ENOUGH BLOOD¿ FROM THE PATIENT. THE REPORTER STATED THAT THE PATIENT HAD BECOME ¿UNRESPONSIVE¿ WHICH THEY ATTRIBUTED TO THE PATIENT HAVING ¿EXTREMELY LOW¿ BLOOD SUGAR. THE REPORTER ADVISED THE CCA THAT THEY WERE GOING TO TERMINATE THE CALL AS THEY PLANNED TO CONTACT THE PARAMEDICS FOR ASSIST

  Patient problems: Loss of consciousness

  MAUDE report 20469298 ↗
• InjuryOct 17, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON SEPTEMBER 26, 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO FLEX METER WAS ¿TESTING IN SETTINGS MODE¿. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL SINCE THE REPORTER COULD NOT BE REACHED WHEN THE CCA ATTEMPTED TO FOLLOW UP WITH THEM TO OBTAIN ADDITIONAL INFORMATION. THE REPORTER WAS UNABLE AND/OR UNWILLING TO ADVISE WHEN THE ALLEGED ISSUE FIRST BEGAN. IT IS NOT KNOWN WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE THEIR DIABETES OR IF THEY MADE ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE CCA WALKED THE REPORTER THROUGH THE CORRECT TESTING PROCEDURE AND NOTED THAT ALTHOUGH THE APPLY SAMPLE ICON APPEARED ON THE SUBJECT METER, THE REPORTER WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING AS THEY WERE ¿NOT GETTING ENOUGH BLOOD¿ FROM THE PATIENT. THE REPORTER STATED THAT THE PATIENT HAD BECOME ¿UNRESPONSIVE¿ WHICH THEY ATTRIBUTED TO THE PATIENT HAVING ¿EXTREMELY LOW¿ BLOOD SUGAR. THE REPORTER ADVISED THE CCA THAT THEY WERE GOING TO TERMINATE THE CALL AS THEY PLANNED TO CONTACT THE PARAMEDICS FOR

  Patient problems: Loss of consciousness

  MAUDE report 20469266 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 16, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY LOW COMPARED TO A HOSPITAL METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING, SINCE THE PATIENT DISCONNECTED THE CALL AND DECLINED TO PROVIDE FURTHER INFORMATION. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 6:00 PM, SHE WENT TO THE EMERGENCY ROOM (ER) AT THE HOSPITAL AS SHE HAD ¿LOW BLOOD SUGAR¿ AND COULD NOT GET HER BLOOD SUGAR UP. IT WAS NOT REPORTED IF THE PATIENT DEVELOPED ANY PHYSICAL SYMPTOMS. UPON ARRIVAL AT ER, THE PATIENT CLAIMED HER BLOOD GLUCOSE HAD RISEN AND A READING OF ¿168 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿197 MG/DL¿ ON THE ER METER WAS OBTAINED. THE PATIENT CLAIMED SHE WAS ADMINISTERED AN ¿IV BAG¿. PRIOR TO ATTENDING ER, THE PATIENT INDICATED THAT HER BLOOD GLUCOSE HAD RISEN FROM ¿23 MG/DL¿ TO ¿71 MG/DL¿ ON THE SUBJECT METER AND THAT SHE HAD TAKEN ORANGE JUICE AND A TOTAL OF 7 GLUCOSE TABLETS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEA

  Patient problems: Hyperglycemia

  MAUDE report 20328659 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 16, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY LOW COMPARED TO A HOSPITAL METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING, SINCE THE PATIENT DISCONNECTED THE CALL AND DECLINED TO PROVIDE FURTHER INFORMATION. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 6:00 PM, SHE WENT TO THE EMERGENCY ROOM (ER) AT THE HOSPITAL AS SHE HAD ¿LOW BLOOD SUGAR¿ AND COULD NOT GET HER BLOOD SUGAR UP. IT WAS NOT REPORTED IF THE PATIENT DEVELOPED ANY PHYSICAL SYMPTOMS. UPON ARRIVAL AFTER, THE PATIENT CLAIMED HER BLOOD GLUCOSE HAD RISEN AND A READING OF ¿168 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿197 MG/DL¿ ON THE ER METER WAS OBTAINED. THE PATIENT CLAIMED SHE WAS ADMINISTERED AN ¿IV BAG¿. PRIOR TO ATTENDING ER, THE PATIENT INDICATED THAT HER BLOOD GLUCOSE HAD RISEN FROM ¿23 MG/DL¿ TO ¿71 MG/DL¿ ON THE SUBJECT METER AND THAT SHE HAD TAKEN ORANGE JUICE AND A TOTAL OF 7 GLUCOSE TABLETS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEA

  Patient problems: Hyperglycemia

  MAUDE report 20328563 ↗
• InjurySep 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THEIR ONETOUCH VERIO FLEX METER WAS READING INACCURATE ERRATICALLY HIGH. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN ON (B)(6) 2024, AT 9 PM. THE PATIENT CLAIMED THAT THEY OBTAINED BLOOD GLUCOSE READINGS WITH THE SUBJECT DEVICE OF ¿174 MG/DL¿ AND ¿276 MG/DL¿ ON THE OTHER HAND. THE PATIENT ALSO MENTIONED OBTAINING ¿300 MG/DL¿. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (HUMULIN R AND HUMULIN N, 25-50 UNITS DEPENDING ON RESULTS) AND STATED THAT THEY INCREASED THEIR INSULIN WITH AN UNSPECIFIED DOSE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT AT APPROXIMATELY 10 PM THAT SAME EVENING THEY STARTED FEELING ¿DIZZY, SHAKING AND NONSTOP SWEATING¿. THE PATIENT MENTIONED THEY FELT SO ¿WORRIED¿, REALIZED THAT THEIR SUGAR LEVEL WAS NOT AS HIGH AS THE SUBJECT METER DISPLAYED, AND ATE SOMETHING. A COUPLE OF HOURS LATER, ON (B)(6) 2024, AT 1 AM, THE PATIENT ATE SOMETHING AGAIN AND DRANK SOME JUICE. THE PATIENT CONTINUED FEELING SYMPTOMS DURING THE NIGHT, LIKE ¿WOOZY AND

  Patient problems: Diaphoresis; Dizziness; Dyspnea; Shaking/Tremors

  MAUDE report 20196785 ↗
• InjurySep 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THEIR ONETOUCH VERIO FLEX METER WAS READING INACCURATE ERRATICALLY HIGH. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN ON (B)(6) 2024, AT 9 PM. THE PATIENT CLAIMED THAT THEY OBTAINED BLOOD GLUCOSE READINGS WITH THE SUBJECT DEVICE OF ¿174 MG/DL¿ AND ¿276 MG/DL¿ ON THE OTHER HAND. THE PATIENT ALSO MENTIONED OBTAINING ¿300 MG/DL¿. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (HUMULIN R AND HUMULIN N, 25-50 UNITS DEPENDING ON RESULTS) AND STATED THAT THEY INCREASED THEIR INSULIN WITH AN UNSPECIFIED DOSE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT AT APPROXIMATELY 10 PM THAT SAME EVENING THEY STARTED FEELING ¿DIZZY, SHAKING AND NONSTOP SWEATING¿. THE PATIENT MENTIONED THEY FELT SO ¿WORRIED¿, REALIZED THAT THEIR SUGAR LEVEL WAS NOT AS HIGH AS THE SUBJECT METER DISPLAYED, AND ATE SOMETHING. A COUPLE OF HOURS LATER, ON (B)(6) 2024, AT 1 AM, THE PATIENT ATE SOMETHING AGAIN AND DRANK SOME JUICE. THE PATIENT CONTINUED FEELING SYMPTOMS DURING THE NIGHT, LIKE ¿WOOZY AND

  Patient problems: Diaphoresis; Dizziness; Dyspnea; Shaking/Tremors

  MAUDE report 20196784 ↗
• InjuryAug 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON AUGUST 22, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AROUND AUGUST 5, 2024. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿108, 46 AND 266 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF DIABETES MEDICATIONS (LANTUS INSULIN, 60 UNITS; REGULAR INSULIN, 50 UNITS; OZEMPIC, ONCE WEEKLY INJECTION). IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 8:00 PM, SHE STARTED HAVING SYMPTOMS OF ¿VERY SLEEPY, BAD HEADACHE, LETHARGIC, STOP TALKING AND PASS OUT¿ AND HER NEIGHBOUR CALLED EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. THE PATIENT REPORTED THAT AT 8:30 PM, PARAMEDICS TREATED HER WITH 2 BAGS OF IV GLUCOSE AND SHE ATE A PEANUT BUTTER SANDWICH AND DRANK A COKE. THE PATIENT CLAIMED SHE RECEIVED A BLOOD GLUCOSE RESULT OF ¿261 MG/DL¿ ON THE EMS MET

  Patient problems: Dysphasia; Headache; Lethargy; Sleepiness/Drowsiness/Somnolence; Syncope/Fainting

  MAUDE report 20082131 ↗
• InjuryAug 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON AUGUST 22, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH VERIO FLEX METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN AROUND (B)(6) 2024. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿108, 46 AND 266 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF DIABETES MEDICATIONS (LANTUS INSULIN, 60 UNITS; REGULAR INSULIN, 50 UNITS; OZEMPIC, ONCE WEEKLY INJECTION). IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ON (B)(6) 2024, AT 8:00 PM, SHE STARTED HAVING SYMPTOMS OF ¿VERY SLEEPY, BAD HEADACHE, LETHARGIC, STOP TALKING AND PASS OUT¿ AND HER NEIGHBOUR CALLED EMERGENCY MEDICAL SERVICES (EMS) FOR ASSISTANCE. THE PATIENT REPORTED THAT AT 8:30 PM, PARAMEDICS TREATED HER WITH 2 BAGS OF IV GLUCOSE AND SHE ATE A PEANUT BUTTER SANDWICH AND DRANK A COKE. THE PATIENT CLAIMED SHE RECEIVED A BLOOD GLUCOSE RESULT OF ¿261 MG/DL¿ ON THE EMS METER

  Patient problems: Dysphasia; Headache; Lethargy; Sleepiness/Drowsiness/Somnolence; Syncope/Fainting

  MAUDE report 20082126 ↗
• InjuryAug 20, 2024Failure to Back-Up; Failure to Back-Up

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING A METER MEMORY ISSUE WITH HER ONETOUCH VERIO FLEX METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT SHE BECAME AWARE OF THE ALLEGED METER ISSUE 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED THAT THE RESULTS BETWEEN JUNE (B)(6) 2024, HAD BEEN ERASED FROM THE METER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH NOVOLOG INSULIN (BEFORE MEALS ON A SLIDING SCALE BASED ON BLOOD GLUCOSE READINGS) AND LANTUS INSULIN (SET DOSE MORNING AND NIGHT) AND TESTS HER BLOOD GLUCOSE 4 TIMES A DAY. THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE, HOWEVER REPORTED BEING TAKEN TO THE EMERGENCY ROOM BY HER SON ON (B)(6) 2024, DUE TO ELEVATED READINGS. THE PATIENT STATED SHE WAS TREATED WITH DOSES OF NOVOLOG AND LANTUS INSULIN ACCORDING TO THEIR PROTOCOL TO BRING THE NUMBERS DOWN AND 1 DOSE OF IV AN

  Patient problems: Hyperglycemia

  MAUDE report 20006658 ↗
• InjuryAug 20, 2024Failure to Back-Up; Failure to Back-Up

  ON AUGUST 6, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING A METER MEMORY ISSUE WITH HER ONETOUCH VERIO FLEX METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING. THE PATIENT REPORTED THAT SHE BECAME AWARE OF THE ALLEGED METER ISSUE 2 WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED THAT THE RESULTS BETWEEN (B)(6) 2024, AND (B)(6) 2024, HAD BEEN ERASED FROM THE METER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH NOVOLOG INSULIN (BEFORE MEALS ON A SLIDING SCALE BASED ON BLOOD GLUCOSE READINGS) AND LANTUS INSULIN (SET DOSE MORNING AND NIGHT) AND TESTS HER BLOOD GLUCOSE 4 TIMES A DAY. THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS AS A RESULT OF THE ALLEGED ISSUE, HOWEVER REPORTED BEING TAKEN TO THE EMERGENCY ROOM BY HER SON ON (B)(6) 2024, DUE TO ELEVATED READINGS. THE PATIENT STATED SHE WAS TREATED WITH DOSES OF NOVOLOG AND LANTUS INSULIN ACCORDING TO THEIR PROTOCOL TO BRING THE NUMBERS DOWN AND

  Patient problems: Hyperglycemia

  MAUDE report 20005423 ↗
• InjuryAug 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON JULY 31, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HIS ONETOUCH VERIO FLEX METER WAS READING INACCURATELY LOW COMPARED TO COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED FEELING HIS GLUCOSE WAS HIGH ON (B)(6) 2024, AT 3:22 PM. 10 MINUTES LATER, THE PATIENT CLAIMED HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AND RECEIVED WHAT HE FELT WAS AN INACCURATE LOW RESULT OF ¿151 MG/DL¿. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN), DIET AND EXERCISE. THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS USUAL DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED ISSUE. HE REPORTEDLY CALLED AN AMBULANCE AND WAS TAKEN TO THE EMERGENCY ROOM AND WAS FEELING ¿DIZZY, COULD NOT TALK AND PASSED OUT¿ IN THE AMBULANCE. THE PATIENT REPORTED THAT HE STAYED AT THE EMERGENCY ROOM FOR 8 HOURS AND WAS TREATED WITH IV FLUIDS AND ADVISED TO GET A REPLACEMENT METER. THE PATIENT INDICATED THAT HE RECEIVED A BLOOD GLUCOSE RESULT OF ¿ABOVE 300 MG/DL¿ ON THE EMERGENCY ROOM METER BEFORE RECEIVING TREATMENT. DURING THE CALL, THE PATIENT ALSO REPORTED OBT

  Patient problems: Dizziness; Dysphasia; Hyperglycemia; Syncope/Fainting

  MAUDE report 19935266 ↗