OneTouch Ultra2 021-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,731 adverse event reports that list this exact device (DI 00353885008372), received between Nov 24, 2016 and Mar 13, 2025 — classified as 1,399 injuries, 332 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (784 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 25 most recent of 1,731 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND COMPARED TO ANOTHER UNKNOWN METER. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND BASED ON ADDITIONAL INFORMATION OBTAINED FROM LISTENING TO THE CALL RECORDING BY A CUSTOMER QUALITY SPECIALIST. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT 4:00 PM ON THE (B)(6) 2024. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿195 MG/DL¿ WITH THE SUBJECT DEVICE WHICH THEY FELT WAS INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND ALSO COMPARED TO A BLOOD GLUCOSE READING OF ¿10 MG/DL¿ WITH AN UNKNOWN EMERGENCY MEDICAL SERVICES (EMS) METER. THE PATIENT DOES NOT HAVE ANY DIABETES MEDICATIONS AND MANAGES THEIR DIABETES WITH DIET AND EXERCISE ONLY. THE PATIENT DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. AT 2:00 PM ON THE (B)(6) 2024, PRIOR TO THE ALLEGED INACCURACY ISSUE THE CUSTOMER FELT ¿WOOZY AND FAINTED¿. THE PATIENT REPORTED THAT AN AMBULANCE WAS CALLED AND RECEIVED A

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 21602188 ↗
• InjuryMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND COMPARED TO ANOTHER UNKNOWN METER. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND BASED ON ADDITIONAL INFORMATION OBTAINED FROM LISTENING TO THE CALL RECORDING BY A CUSTOMER QUALITY SPECIALIST. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN AT 4:00 PM ON THE (B)(6) 2024. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿195 MG/DL¿ WITH THE SUBJECT DEVICE WHICH THEY FELT WAS INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND ALSO COMPARED TO A BLOOD GLUCOSE READING OF ¿10 MG/DL¿ WITH AN UNKNOWN EMERGENCY MEDICAL SERVICES (EMS) METER. THE PATIENT DOES NOT HAVE ANY DIABETES MEDICATIONS AND MANAGES THEIR DIABETES WITH DIET AND EXERCISE ONLY. THE PATIENT DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. AT 2:00 PM ON THE (B)(6) 2024, PRIOR TO THE ALLEGED INACCURACY ISSUE THE CUSTOMER FELT ¿WOOZY AND FAINTED¿. THE PATIENT REPORTED THAT AN AMBULANCE WAS CALLED AND RECEIVED A

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 21602185 ↗
• InjuryDec 10, 2024Imprecision; Imprecision

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER DISPLAYED THE CALCODE AND DID NOT PROVIDE A READING. 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. IT WAS NOT REPORTED WHEN THE ALLEGED ISSUE STARTED. THE PATIENT CLAIMED THAT EVERY TIME THEY TRIED PERFORMING A BLOOD GLUCOSE TEST, THEY SAW CODE 25 AND THEN A MESSAGE APPEARED THAT THEY COULD NOT READ BECAUSE THEY HAD CATARACT SURGERY. THE PATIENT DID NOT PROVIDE INFORMATION ON HOW THEY MANAGE THEIR DIABETES, NOR DID THEY REPORT WHETHER THEY MADE ANY CHANGES IN RESPONSE TO THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿HEAD SHAKY, FALLING BACK LIKE HAVING CONVULSIONS¿. THE PATIENT HAD TO GO TO THE EMERGENCY ROOM (ER) WHERE A BLOOD GLUCOSE READING OF ¿535 MG/DL¿ WAS OBTAINED ON A HOSPITAL METER. THE PATIENT WAS TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH INSULIN AND AN IV. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THE ISSUE WAS RESOLVED ON THE

  Patient problems: Convulsion/Seizure; Fall; Shaking/Tremors

  MAUDE report 20898699 ↗
• InjuryDec 10, 2024Imprecision; Imprecision

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER DISPLAYED THE CALCODE AND DID NOT PROVIDE A READING. 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. IT WAS NOT REPORTED WHEN THE ALLEGED ISSUE STARTED. THE PATIENT CLAIMED THAT EVERY TIME THEY TRIED PERFORMING A BLOOD GLUCOSE TEST, THEY SAW CODE 25 AND THEN A MESSAGE APPEARED THAT THEY COULD NOT READ BECAUSE THEY HAD CATARACT SURGERY. THE PATIENT DID NOT PROVIDE INFORMATION ON HOW THEY MANAGE THEIR DIABETES, NOR DID THEY REPORT WHETHER THEY MADE ANY CHANGES IN RESPONSE TO THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT DEVELOPED SYMPTOMS OF ¿HEAD SHAKY, FALLING BACK LIKE HAVING CONVULSIONS¿. THE PATIENT HAD TO GO TO THE EMERGENCY ROOM (ER) WHERE A BLOOD GLUCOSE READING OF ¿535 MG/DL¿ WAS OBTAINED ON A HOSPITAL METER. THE PATIENT WAS TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH INSULIN AND AN IV. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THE ISSUE WAS RESOLVED ON THE

  Patient problems: Convulsion/Seizure; Fall; Shaking/Tremors

  MAUDE report 20898691 ↗
• InjuryDec 6, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ON NOVEMBER 21, 2024, THE REPORTER OF THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA 2 METER WAS DISPLAYING THE ¿ERROR 5¿ MESSAGE AFTER APPLYING A BLOOD SAMPLE. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ON ADDITIONAL INFORMATION OBTAINED DURING REVIEW OF THE CALL RECORDING. THE REPORTER ALLEGED THAT THE ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2024, AT 2:30 PM. HOWEVER, THE REPORTER INFORMED THE CCA THAT THE PATIENT FELT ¿DIZZY, BALANCE WAS OFF AND DISORIENTATED¿ SINCE (B)(6) 2024. ON (B)(6) 2024, THE PATIENT¿S SYMPTOMS STARTED WORSENING, AND THEY DECIDED TO INCREASE THEIR DIABETES MEDICATION. THE PATIENT MANAGES THEIR DIABETES WITH PILLS (GLIMEPIRIDE 1 MG) WITH DIET AND/OR EXERCISE AND CLAIMED THEY INCREASED THEIR MEDICATION BY TAKING 2 MG OF GLIMEPERIDE INSTEAD, EXPECTING THIS WAS GOING TO HELP THEIR ¿HIGH SUGAR¿. AT 11 AM THAT SAME DAY, THE REPORTER FOUND THE PATIENT¿S SYMPTOMS WERE WORSE THAN BEFORE AND THEY TRIED PERFORMING A BLOOD GLUCOSE TEST ON THE SUBJECT METER BUT WERE UNABLE TO GET A READING DUE TO THE ALLEGED ISSUE. AROUND 5 PM THAT DAY, THE PAT

  Patient problems: Confusion/ Disorientation; Dizziness; Vertigo

  MAUDE report 20860895 ↗
• InjuryDec 6, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ON NOVEMBER 21, 2024, THE REPORTER OF THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA 2 METER WAS DISPLAYING THE ¿ERROR 5¿ MESSAGE AFTER APPLYING A BLOOD SAMPLE. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ON ADDITIONAL INFORMATION OBTAINED DURING REVIEW OF THE CALL RECORDING. THE REPORTER ALLEGED THAT THE ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2024, AT 2:30 PM. HOWEVER, THE REPORTER INFORMED THE CCA THAT THE PATIENT FELT ¿DIZZY, BALANCE WAS OFF AND DISORIENTATED¿ SINCE (B)(6) 2024. ON (B)(6) 2024, THE PATIENT¿S SYMPTOMS STARTED WORSENING, AND THEY DECIDED TO INCREASE THEIR DIABETES MEDICATION. THE PATIENT MANAGES THEIR DIABETES WITH PILLS (GLIMEPIRIDE 1 MG) WITH DIET AND/OR EXERCISE AND CLAIMED THEY INCREASED THEIR MEDICATION BY TAKING 2 MG OF GLIMEPERIDE INSTEAD, EXPECTING THIS WAS GOING TO HELP THEIR ¿HIGH SUGAR¿. AT 11 AM THAT SAME DAY, THE REPORTER FOUND THE PATIENT¿S SYMPTOMS WERE WORSE THAN BEFORE AND THEY TRIED PERFORMING A BLOOD GLUCOSE TEST ON THE SUBJECT METER BUT WERE UNABLE TO GET A READING DUE TO THE ALLEGED ISSUE. AROUND 5 PM THAT DAY, THE PAT

  Patient problems: Confusion/ Disorientation; Dizziness; Vertigo

  MAUDE report 20860615 ↗
• InjuryNov 21, 2024Device Alarm System; Device Alarm System

  ON (B)(6) 2024, THE REPORTER OF THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS MOTHER¿S ONETOUCH ULTRA 2 METER DISPLAYED THE METER MESSAGE ¿APPLY BLOOD¿ AFTER APPLYING A BLOOD SAMPLE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER CLAIMED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2024, AROUND 8 AM, WHEN HIS MOTHER TRIED PERFORMING A TEST BEFORE BREAKFAST AS SHE USUALLY DOES. THE PATIENT MANAGES HER DIABETES WITH A FIXED DOSE OF UNSPECIFIED INSULIN (14 UNITS ONCE A DAY AT NIGHT) AND THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT WAS UNABLE TO CHECK HER BLOOD GLUCOSE LEVELS FOR TWO DAYS AND STARTED PRESENTING SYMPTOMS OF ¿FEELING DIZZY, COULD NOT WALK, NO STRENGTH IN HER BODY AND COULD NOT TALK AND WAS MUMBLING¿ ON (B)(6) 2024, AROUND 8 AM. THE REPORTER CALLED AN AMBULANCE, AND THEY TOOK A BLOOD GLUCOSE READING OF ¿52 MG/DL¿ ON AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE PATIENT WAS BROUGHT TO THE HOSPITAL WHERE SHE RECEIVED IV FLUIDS AND WAS HOSPITALIZED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME

  Patient problems: Dizziness; Dysphasia; Fatigue

  MAUDE report 20754293 ↗
• InjuryNov 21, 2024Device Alarm System; Device Alarm System

  ON (B)(6) 2024, THE REPORTER OF THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS MOTHER¿S ONETOUCH ULTRA 2 METER DISPLAYED THE METER MESSAGE ¿APPLY BLOOD¿ AFTER APPLYING A BLOOD SAMPLE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER CLAIMED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2024, AROUND 8 AM, WHEN HIS MOTHER TRIED PERFORMING A TEST BEFORE BREAKFAST AS SHE USUALLY DOES. THE PATIENT MANAGES HER DIABETES WITH A FIXED DOSE OF UNSPECIFIED INSULIN (14 UNITS ONCE A DAY AT NIGHT) AND THE REPORTER DENIED THAT THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT WAS UNABLE TO CHECK HER BLOOD GLUCOSE LEVELS FOR TWO DAYS AND STARTED PRESENTING SYMPTOMS OF ¿FEELING DIZZY, COULD NOT WALK, NO STRENGTH IN HER BODY AND COULD NOT TALK AND WAS MUMBLING¿ ON (B)(6) 2024, AROUND 8 AM. THE REPORTER CALLED AN AMBULANCE, AND THEY TOOK A BLOOD GLUCOSE READING OF ¿52 MG/DL¿ ON AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE PATIENT WAS BROUGHT TO THE HOSPITAL WHERE SHE RECEIVED IV FLUIDS AND WAS HOSPITALIZED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME

  Patient problems: Dizziness; Dysphasia; Fatigue

  MAUDE report 20754286 ↗
• InjuryNov 7, 2024Device Handling Problem; Device Handling Problem

  ON (B)(6) 2024, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS DISPLAYING INACCURATE ERRATIC READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2024, AT 10 AM. THE PATIENT RECEIVED BLOOD GLUCOSE READINGS OF ¿60, 500 AND 210 MG/DL¿ ON THE SUBJECT METER, WITHIN 20 MINUTES APART FROM EACH OTHER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (LANTUS 25 UNITS) AND STATED THAT 5 MINUTES LATER THEY INCREASED THEIR DOSE OF INSULIN BY 31 UNITS IN RESPONSE TO THE ALLEGED ISSUE. AT 11 AM THAT SAME DAY, THE PATIENT STARTED ¿SHAKING, VOMITING AND PASSED OUT¿. THE PATIENT WENT TO THE HOSPITAL WHERE THEY WERE TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH A SUGAR SOLUTION. THE PATIENT COULD NOT RECALL THE DOSE THAT WAS GIVEN. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES AND THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AT THE TIME O

  Patient problems: Shaking/Tremors; Syncope/Fainting; Vomiting

  MAUDE report 20636229 ↗
• InjuryNov 7, 2024Device Handling Problem; Device Handling Problem

  ON (B)(6) 2024, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS DISPLAYING INACCURATE ERRATIC READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2024, AT 10 AM. THE PATIENT RECEIVED BLOOD GLUCOSE READINGS OF ¿60, 500 AND 210 MG/DL¿ ON THE SUBJECT METER, WITHIN 20 MINUTES APART FROM EACH OTHER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (LANTUS 25 UNITS) AND STATED THAT 5 MINUTES LATER THEY INCREASED THEIR DOSE OF INSULIN BY 31 UNITS IN RESPONSE TO THE ALLEGED ISSUE. AT 11 AM THAT SAME DAY, THE PATIENT STARTED ¿SHAKING, VOMITING AND PASSED OUT¿. THE PATIENT WENT TO THE HOSPITAL WHERE THEY WERE TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH A SUGAR SOLUTION. THE PATIENT COULD NOT RECALL THE DOSE THAT WAS GIVEN. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES AND THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AT THE TIME O

  Patient problems: Shaking/Tremors; Syncope/Fainting; Vomiting

  MAUDE report 20635056 ↗
• InjuryNov 1, 2024Device Handling Problem; Device Handling Problem

  ON OCTOBER 17, 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN PROBABLY 1 YEAR PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿500, 300, 200 AND 335 MG/DL¿ WITH THE SUBJECT METER, PERFORMED MORE THAN 20 MINUTES APART. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN AND ORAL MEDICATION. SHE REPORTED TAKING MORE INSULIN IN RESPONSE TO THE ALLEGED INACCURATE READINGS. SHE REPORTED THAT SHE BEGAN ¿THROWING UP¿ AND COULD ¿NOT EAT ANYTHING¿ AT UNSPECIFIED DATES AND TIMES DUE TO THE ALLEGED ISSUE. DURING THE FOLLOW-UP CALL, THE PATIENT INDICATED THAT SHE ASSOCIATED THE SYMPTOMS WITH A HIGH BLOOD GLUCOSE LEVEL. ON (B)(6) 2024, THE PATIENT WENT TO THE HOSPITAL AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. DURING THE FOLLOW-UP CALL, THE PATIENT STATED THAT HER BLOOD GLUCOSE WAS MEASURED ON ARRIVAL AT THE HOSPITAL BUT WAS UNABLE TO RECALL THE RESULT OBTAINED

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 20593773 ↗
• InjuryNov 1, 2024Device Handling Problem; Device Handling Problem

  ON (B)(6) 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN PROBABLY 1 YEAR PRIOR TO CONTACTING LFS. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿500, 300, 200 AND 335 MG/DL¿ WITH THE SUBJECT METER, PERFORMED MORE THAN 20 MINUTES APART. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN AND ORAL MEDICATION. SHE REPORTED TAKING MORE INSULIN IN RESPONSE TO THE ALLEGED INACCURATE READINGS. SHE REPORTED THAT SHE BEGAN ¿THROWING UP¿ AND COULD ¿NOT EAT ANYTHING¿ AT UNSPECIFIED DATES AND TIMES DUE TO THE ALLEGED ISSUE. DURING THE FOLLOW-UP CALL, THE PATIENT INDICATED THAT SHE ASSOCIATED THE SYMPTOMS WITH A HIGH BLOOD GLUCOSE LEVEL. ON (B)(6) 2024, THE PATIENT WENT TO THE HOSPITAL AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. DURING THE FOLLOW-UP CALL, THE PATIENT STATED THAT HER BLOOD GLUCOSE WAS MEASURED ON ARRIVAL AT THE HOSPITAL BUT WAS UNABLE TO RECALL THE RESULT OBTAINED. NO

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 20593770 ↗
• InjuryOct 29, 2024Power Problem; Power Problem

  ON (B)(6) 2024, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA2 METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, ON REVIEW OF THE CALL RECORDING AND ON ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE STARTED TWO DAYS PRIOR TO THE CALL WITH LFS, AT AN UNSPECIFIED DATE. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION (HUMALOG INSULIN AND TOUJEO INSULIN ¿ DOSE UNSPECIFIED) AND CLAIMED THAT THEY INCREASED THEIR HUMALOG INSULIN BY 7 UNITS AND THEIR TOUJEO INSULIN BY 5 UNITS IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE, HOWEVER, THE PATIENT STATED THAT THEY WENT TO THE EMERGENCY ROOM (ER) AFTER THEY OBTAINED A BLOOD GLUCOSE READING OF ¿480 MG/DL¿ ON THE SUBJECT METER, TWO DAYS PRIOR TO THE CALL WITH LFS. DURING FOLLOW UP, THE PATIENT CONFIRMED THAT THEY WERE TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH HUMALOG INSULIN TWICE AND AN UNSPECIFIED LONG-ACTING INSULIN. BEFORE AND AFTER TREATMENT UNSPECIFIED BLOOD GLUCOSE READINGS WERE OBTAINED AT THE

  Patient problems: Hyperglycemia

  MAUDE report 20563823 ↗
• InjuryOct 29, 2024Power Problem; Power Problem

  ON (B)(6) 2024, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONE TOUCH ULTRA2 METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, ON REVIEW OF THE CALL RECORDING AND ON ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE STARTED TWO DAYS PRIOR TO THE CALL WITH LFS, AT AN UNSPECIFIED DATE. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF MEDICATION (HUMALOG INSULIN AND TOUJEO INSULIN ¿ DOSE UNSPECIFIED) AND CLAIMED THAT THEY INCREASED THEIR HUMALOG INSULIN BY 7 UNITS AND THEIR TOUJEO INSULIN BY 5 UNITS IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE, HOWEVER, THE PATIENT STATED THAT THEY WENT TO THE EMERGENCY ROOM (ER) AFTER THEY OBTAINED A BLOOD GLUCOSE READING OF ¿480 MG/DL¿ ON THE SUBJECT METER, TWO DAYS PRIOR TO THE CALL WITH LFS. DURING FOLLOW UP, THE PATIENT CONFIRMED THAT THEY WERE TREATED BY A HEALTH CARE PROFESSIONAL (HCP) WITH HUMALOG INSULIN TWICE AND AN UNSPECIFIED LONG-ACTING INSULIN. BEFORE AND AFTER TREATMENT UNSPECIFIED BLOOD GLUCOSE READINGS WERE OBTAINED AT TH

  Patient problems: Hyperglycemia

  MAUDE report 20563817 ↗
• InjuryOct 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON OCTOBER 10, 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON THE NIGHT OF (B)(6) 2024. THE REPORTER CLAIMED THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿479 MG/DL¿ WITH THE SUBJECT METER. IN RESPONSE TO THE ELEVATED READING, THE REPORTER INDICATED THAT THE PATIENT TOOK AN INCREASED DOSE OF 10 UNITS OF INSULIN (TYPE UNSPECIFIED) THEN BEGAN ¿FOAMING AND PASSED OUT¿. THE REPORTER CALLED AN AMBULANCE AND WHEN THEY ARRIVED, THE PATIENT¿S BLOOD GLUCOSE READ ¿25 MG/DL¿ ON THE AMBULANCE METER. IT WAS NOT REPORTED WHAT TREATMENT THE PATIENT RECEIVED. THE REPORTER ALSO MENTIONED THE PATIENT WAS ¿BRUISED UP¿ BECAUSE OF ALL THE PRICKS SHE HAD RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT, AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE

  Patient problems: Bruise/Contusion; Hypoglycemia; Salivary Hypersecretion; Syncope/Fainting

  MAUDE report 20519344 ↗
• InjuryOct 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON OCTOBER 10, 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON THE NIGHT OF (B)(6) 2024. THE REPORTER CLAIMED THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿479 MG/DL¿ WITH THE SUBJECT METER. IN RESPONSE TO THE ELEVATED READING, THE REPORTER INDICATED THAT THE PATIENT TOOK AN INCREASED DOSE OF 10 UNITS OF INSULIN (TYPE UNSPECIFIED) THEN BEGAN ¿FOAMING AND PASSED OUT¿. THE REPORTER CALLED AN AMBULANCE AND WHEN THEY ARRIVED, THE PATIENT¿S BLOOD GLUCOSE READ ¿25 MG/DL¿ ON THE AMBULANCE METER. IT WAS NOT REPORTED WHAT TREATMENT THE PATIENT RECEIVED. THE REPORTER ALSO MENTIONED THE PATIENT WAS ¿BRUISED UP¿ BECAUSE OF ALL THE PRICKS SHE HAD RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT, AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE

  Patient problems: Bruise/Contusion; Hypoglycemia; Salivary Hypersecretion; Syncope/Fainting

  MAUDE report 20519087 ↗
• InjuryOct 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON THE NIGHT OF OCTOBER 5, 2024. THE REPORTER CLAIMED THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿500 MG/DL¿ WITH THE SUBJECT METER. IN RESPONSE TO THE ELEVATED READING, THE REPORTER INDICATED THAT THE PATIENT TOOK A SHOT OF INSULIN (TYPE/DOSE UNSPECIFIED) THEN BEGAN ¿FOAMING AND PASSED OUT¿. THE REPORTER CALLED AN AMBULANCE AND WHEN THEY ARRIVED, THE PATIENT¿S BLOOD GLUCOSE READ ¿22 MG/DL¿ ON THE AMBULANCE METER. THE REPORTER INDICATED THAT THE PATIENT WAS GIVEN A GLUCAGON INJECTION AND TAKEN TO HOSPITAL. THE REPORTER STATED THAT THE PATIENT WAS HOSPITALIZED FOR 3 DAYS BECAUSE "THEY DIDN'T KNOW WHY HER SUGAR WAS UP AND DOWN". THE REPORTER ALSO MENTIONED THE PATIENT WAS ¿BRUISED UP¿ BECAUSE OF ALL THE PRICKS SHE HAD RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS

  Patient problems: Bruise/Contusion; Hypoglycemia; Salivary Hypersecretion; Syncope/Fainting

  MAUDE report 20518900 ↗
• InjuryOct 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON OCTOBER 10, 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON THE NIGHT OF (B)(6) 2024. THE REPORTER CLAIMED THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿500 MG/DL¿ WITH THE SUBJECT METER. IN RESPONSE TO THE ELEVATED READING, THE REPORTER INDICATED THAT THE PATIENT TOOK A SHOT OF INSULIN (TYPE/DOSE UNSPECIFIED) THEN BEGAN ¿FOAMING AND PASSED OUT¿. THE REPORTER CALLED AN AMBULANCE AND WHEN THEY ARRIVED, THE PATIENT¿S BLOOD GLUCOSE READ ¿22 MG/DL¿ ON THE AMBULANCE METER. THE REPORTER INDICATED THAT THE PATIENT WAS GIVEN A GLUCAGON INJECTION AND TAKEN TO HOSPITAL. THE REPORTER STATED THAT THE PATIENT WAS HOSPITALIZED FOR 3 DAYS BECAUSE "THEY DIDN'T KNOW WHY HER SUGAR WAS UP AND DOWN". THE REPORTER ALSO MENTIONED THE PATIENT WAS ¿BRUISED UP¿ BECAUSE OF ALL THE PRICKS SHE HAD RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS

  Patient problems: Bruise/Contusion; Hypoglycemia; Salivary Hypersecretion; Syncope/Fainting

  MAUDE report 20518758 ↗
• InjuryOct 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6), 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED AT AN UNSPECIFIED TIME ON (B)(6) 2024. THE REPORTER CLAIMED THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿500 MG/DL¿ WITH THE SUBJECT METER. IN RESPONSE TO THE ELEVATED READING, THE REPORTER INDICATED THAT THE PATIENT TOOK AN INCREASED DOSE OF (B)(4) UNITS OF INSULIN (TYPE UNSPECIFIED) THEN 30 MINUTES LATER ¿PASSED OUT IN THE CAR¿. THE REPORTER CALLED AN AMBULANCE AND WHEN THEY ARRIVED, THE PATIENT¿S BLOOD GLUCOSE READ ¿22 MG/DL¿ ON THE AMBULANCE METER. THE REPORTER INDICATED THAT THE PATIENT WAS GIVEN A GLUCAGON INJECTION. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT, AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THIS COMPLAINT IS B

  Patient problems: Hypoglycemia; Syncope/Fainting

  MAUDE report 20518749 ↗
• InjuryOct 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON OCTOBER 10, 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED AT AN UNSPECIFIED TIME ON (B)(6) 2024. THE REPORTER CLAIMED THE PATIENT OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿500 MG/DL¿ WITH THE SUBJECT METER. IN RESPONSE TO THE ELEVATED READING, THE REPORTER INDICATED THAT THE PATIENT TOOK AN INCREASED DOSE OF 10 UNITS OF INSULIN (TYPE UNSPECIFIED) THEN 30 MINUTES LATER ¿PASSED OUT IN THE CAR¿. THE REPORTER CALLED AN AMBULANCE AND WHEN THEY ARRIVED, THE PATIENT¿S BLOOD GLUCOSE READ ¿22 MG/DL¿ ON THE AMBULANCE METER. THE REPORTER INDICATED THAT THE PATIENT WAS GIVEN A GLUCAGON INJECTION. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT, AND THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THIS COMPLAINT IS B

  Patient problems: Hypoglycemia; Syncope/Fainting

  MAUDE report 20518717 ↗
• InjurySep 20, 2024Failure to Calibrate; Failure to Calibrate

  ON (B)(6) 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER INDICATED THAT THE ALLEGED POWER ISSUE BEGAN AROUND (B)(6) 2024. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE. THE REPORTER CLAIMED THE PATIENT CONTINUED TO FOLLOW THEIR USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER INDICATED THAT 1 DAY PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT BEGAN TO DEVELOP SYMPTOMS OF ¿WEAKNESS IN LEGS, DIZZINESS AND VOMITING¿. HOWEVER, 2 DAYS AFTER THE START OF THE ALLEGED ISSUE THE PATIENT¿S SYMPTOMS WORSENED. THE REPORTER CLAIMED THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE THEY WERE TREATED WITH 2 DOSES OF INSULIN (TYPE/AMOUNT NOT REPORTED) AND THE PATIENT FELT BETTER AFTERWARDS. THE REPORTER CLAIMED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿128 MG/DL¿ ON THE DOCTOR¿S METER AFTER RECEIVING THE TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THERE WAS

  Patient problems: Dizziness; Muscle Weakness/Atrophy; Vomiting

  MAUDE report 20274664 ↗
• InjurySep 20, 2024Failure to Calibrate; Failure to Calibrate

  ON SEPTEMBER 13, 2024, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER INDICATED THAT THE ALLEGED POWER ISSUE BEGAN AROUND (B)(6) 2024. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION, DIET AND EXERCISE. THE REPORTER CLAIMED THE PATIENT CONTINUED TO FOLLOW THEIR USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER INDICATED THAT 1 DAY PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT BEGAN TO DEVELOP SYMPTOMS OF ¿WEAKNESS IN LEGS, DIZZINESS AND VOMITING¿. HOWEVER, 2 DAYS AFTER THE START OF THE ALLEGED ISSUE THE PATIENT¿S SYMPTOMS WORSENED. THE REPORTER CLAIMED THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE THEY WERE TREATED WITH 2 DOSES OF INSULIN (TYPE/AMOUNT NOT REPORTED) AND THE PATIENT FELT BETTER AFTERWARDS. THE REPORTER CLAIMED THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿128 MG/DL¿ ON THE DOCTOR¿S METER AFTER RECEIVING THE TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THE

  Patient problems: Dizziness; Muscle Weakness/Atrophy; Vomiting

  MAUDE report 20274645 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  ON (B)(6) 2024, THE LAY USER/PATIENT¿S DAUGHTER CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC AND INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER DISCONNECTED THE CALL AND CONTACT INFORMATION WAS NOT AVAILABLE FOR FURTHER INFORMATION TO BE OBTAINED. IT WAS NOT REPORTED WHEN THE ALLEGED INACCURACY ISSUE BEGAN. THE REPORTER CLAIMED THAT ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿107 AND 96 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BETWEEN THE TESTS THE PATIENT HAD EATEN BREAKFAST. THE REPORTER MENTIONED THAT A NORMAL RESULT FOR THE PATIENT AFTER BREAKFAST IS IN THE ¿130S MG/DL¿ RANGE. IT WAS NOT REPORTED WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE HER DIABETES OR IF SHE TOOK ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT ON ANOTHER FURTHER OCCASION ON (B)(6) 2024, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿117 MG/DL¿ WITH THE SUBJECT METER AFTER DINNER AND FELT SYMPTOMS OF ¿

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 20186641 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  ON AUGUST 27, 2024, THE LAY USER/PATIENT¿S DAUGHTER CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC AND INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER DISCONNECTED THE CALL AND CONTACT INFORMATION WAS NOT AVAILABLE FOR FURTHER INFORMATION TO BE OBTAINED. IT WAS NOT REPORTED WHEN THE ALLEGED INACCURACY ISSUE BEGAN. THE REPORTER CLAIMED THAT ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿107 AND 96 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BETWEEN THE TESTS THE PATIENT HAD EATEN BREAKFAST. THE REPORTER MENTIONED THAT A NORMAL RESULT FOR THE PATIENT AFTER BREAKFAST IS IN THE ¿130S MG/DL¿ RANGE. IT WAS NOT REPORTED WHAT MEDICATION, IF ANY, THE PATIENT TAKES TO MANAGE HER DIABETES OR IF SHE TOOK ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT ON ANOTHER FURTHER OCCASION ON (B)(6) 2024, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿117 MG/DL¿ WITH THE SUBJECT METER AFTER DINNER AND FELT SYMPTOMS

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 20186632 ↗
• InjuryAug 14, 2024Device Handling Problem; Device Handling Problem

  ON (B)(6) 2024, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA 2 METER WAS READING INACCURATELY 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 ISSUE STARTED ON (B)(6) 2024, AT 9 PM. THE PATIENT STATED THAT THEY RECEIVED A BLOOD GLUCOSE READING OF ¿250 MG/DL¿ ON THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN (HUMALOG 39 UNITS AND LEVEMIR 42 UNITS) AND CLAIMED THAT THEY REDUCED THEIR FOOD INTAKE AND ONLY TOOK A LIGHT MEAL IN RESPONSE TO THE RESULTS RECEIVED THAT EVENING. ON (B)(6) 2024, AT 2 AM, THE PATIENT WOKE UP FEELING ¿SWEATY AND EXTREMELY CONFUSED¿. THE PATIENT¿S WIFE CALLED THE PARAMEDICS, AND A HEALTH CARE PROFESSIONAL (HCP) TREATED THE PATIENT WITH IV GLUCOSE. BEFORE TREATMENT A BLOOD GLUCOSE READING OF ¿39 MG/DL¿ WAS OBTAINED ON AN EMERGENCY MEDICAL SERVICE (EMS) METER. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES. THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AT THE TIME OF THE CALL TO TEST THE SUBJECT SYSTEM. T

  Patient problems: Confusion/ Disorientation; Diaphoresis

  MAUDE report 19988476 ↗