OneTouch Verio Reflect 023-878Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00353885011709), received between Nov 12, 2019 and Aug 14, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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. 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 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 ¿NITROSTROS¿ MEDICATION IN HER MOUTH ¿TO WAKE HER UP¿. THE REPORTER CLAIMED A BLOOD GLUCOSE TEST WAS PERFORMED ON A NEIGHBOR¿S METER PRIOR TO RECEIVING TRE

  Patient problems: Dizziness; Extreme Exhaustion; Hypoglycemia; Pallor; Presyncope

  MAUDE report 16475120 ↗
• InjuryMar 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2022, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. 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 BEGAN ON (B)(6) 2022. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿201 MG/DL¿ AT 4 AM AND ¿209 MG/DL¿ AT 5 AM WITH THE SUBJECT METER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH DIET AND EXERCISE AND TAKES NON-DIABETES RELATED MEDICATION (NOVATEC, TWICE A DAY). THE PATIENT DENIED THAT SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. ON THAT SAME MORNING, BETWEEN 4 AND 5 AM, THE PATIENT STARTED ¿SHAKING¿. THE PATIENT CLAIMED THAT SHE GOT SOME REST, TOOK ANOTHER BLOOD GLUCOSE TEST AT HER USUAL TIME 6:40 AM AND RECEIVED A RESULT OF ¿230 MG/DL¿ ON THE SUBJECT METER. THE PATIENT INFORMED THAT SHE ATE BREAKFAST (4 RUSKS WITH WHITE CHEESE) AND INDICATED THAT SHE FELT A BIT BETTER. THERE WAS NO REPORT OF ANY MEDICAL TREATMENT/INTERVENTION RECEIVED AS A RESULT OF THE AL

  Patient problems: Shaking/Tremors

  MAUDE report 13745306 ↗
• InjuryMar 12, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON MARCH 9, 2022, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) FRANCE, ALLEGING THAT HER ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. 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 BEGAN ON MARCH 9, 2022. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿201 MG/DL¿ AT 4 AM AND ¿209 MG/DL¿ AT 5 AM WITH THE SUBJECT METER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH DIET AND EXERCISE AND TAKES NON-DIABETES RELATED MEDICATION (NOVATEC, TWICE A DAY). THE PATIENT DENIED THAT SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. ON THAT SAME MORNING, BETWEEN 4 AND 5 AM, THE PATIENT STARTED ¿SHAKING¿. THE PATIENT CLAIMED THAT SHE GOT SOME REST, TOOK ANOTHER BLOOD GLUCOSE TEST AT HER USUAL TIME 6:40 AM AND RECEIVED A RESULT OF ¿230 MG/DL¿ ON THE SUBJECT METER. THE PATIENT INFORMED THAT SHE ATE BREAKFAST (4 RUSKS WITH WHITE CHEESE) AND INDICATED THAT SHE FELT A BIT BETTER. THERE WAS NO REPORT OF ANY MEDICAL TREATMENT/INTERVENTION RECEIVED AS A RESULT OF TH

  Patient problems: Shaking/Tremors

  MAUDE report 13745173 ↗
• InjuryJan 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH VERIO REFLECT METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2021 AT 6:12 PM. THE PATIENT REPORTED OBTAINING AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿122 MG/DL¿ WITH THE SUBJECT. THE PATIENT MANAGES HIS DIABETES WITH A FIXED DOSE OF INSULIN (10 UNITS DAILY AFTER EVENING MEAL). THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT 15 MINUTES AFTER THE ALLEGED ISSUE OCCURRED , HE DEVELOPED SYMPTOMS OF ¿EYE PAIN LIKE A MIGRAINE, WEAK AND SHAKING;¿ SYMPTOMS HE ASSOCIATED WITH HYPOGLYCEMIA. THE PATIENT CLAIMED HE TREATED HIMSELF WITH SUGAR IN RESPONSE TO THE SYMPTOMS AND FELT BETTER A FEW MINUTES AFTERWARDS. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HIS BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE PATIENT DID NOT HA

  Patient problems: Fatigue; Headache; Hypoglycemia; Shaking/Tremors

  MAUDE report 11224176 ↗
• InjuryJan 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH VERIO REFLECT METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2021 AT 6:12 PM. THE PATIENT REPORTED OBTAINING AN INACCURATE HIGH BLOOD GLUCOSE READING OF ¿122 MG/DL¿ WITH THE SUBJECT. THE PATIENT MANAGES HIS DIABETES WITH A FIXED DOSE OF INSULIN (10 UNITS DAILY AFTER EVENING MEAL). THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT 15 MINUTES AFTER THE ALLEGED ISSUE OCCURRED , HE DEVELOPED SYMPTOMS OF ¿EYE PAIN LIKE A MIGRAINE, WEAK AND SHAKING;¿ SYMPTOMS HE ASSOCIATED WITH HYPOGLYCEMIA. THE PATIENT CLAIMED HE TREATED HIMSELF WITH SUGAR IN RESPONSE TO THE SYMPTOMS AND FELT BETTER A FEW MINUTES AFTERWARDS. THE PATIENT DENIED USING ANY OTHER DEVICE TO TEST HIS BLOOD GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE PATIENT DID NOT HA

  Patient problems: Fatigue; Headache; Hypoglycemia; Shaking/Tremors

  MAUDE report 11224147 ↗
• InjuryNov 12, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, A REPORTER FOR THE PATIENT (THE PATIENT¿S WIFE) CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO THE PATIENT¿S FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER CLAIMED THAT AT 8:05 PM ON (B)(6) 2019, THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL USING THE SUBJECT METER AND OBTAINED A RESULT OF ¿474MG/DL¿; THE PATIENT CONSIDERED THIS RESULT HIGH COMPARED TO HIS USUAL PRE-EVENING MEAL RESULT OF ¿105 MG/DL¿ . THE PATIENT MANAGES HIS DIABETES WITH INSULIN WHICH HE SELF- ADJUSTS. THE REPORTER STATED THAT AFTER OBTAINING THE ¿HIGH¿ RESULT, THE PATIENT TESTED HIS BLOOD GLUCOSE LEVELS AT 8:08 PM AND 8:13 PM, OBTAINING READINGS OF ¿463 MG/DL¿ AND ¿277 MG/DL¿, RESPECTIVELY. THE REPORTER INDICATED THAT AT 8:13 PM, THE PATIENT ADMINISTERED AN INCREASED INSULIN DOSE (EXACT BRAND/DOSE NOT KNOWN BY REPORTER). THE REPORTER STATED THAT SOMETIME AFTER ADMINISTERING THE INSULIN, THE PATIENT ¿FELT FAINT¿ WITH SYMPTOMS OF ¿TREMBLING AND SWEATING¿. SHE REPORTED THAT THE PATIENT SELF-TREATED HIS SYMPTOMS BY CONSUMING FOOD

  Patient problems: Shaking/Tremors; Sweating; Syncope

  MAUDE report 9309488 ↗
• InjuryNov 12, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2019, A REPORTER FOR THE PATIENT (THE PATIENT¿S WIFE) CONTACTED LIFESCAN (LFS) FRANCE, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO REFLECT METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO THE PATIENT¿S FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER CLAIMED THAT AT 8:05 PM ON (B)(6) 2019, THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL USING THE SUBJECT METER AND OBTAINED A RESULT OF ¿474MG/DL¿; THE PATIENT CONSIDERED THIS RESULT HIGH COMPARED TO HIS USUAL PRE-EVENING MEAL RESULT OF ¿105 MG/DL¿ . THE PATIENT MANAGES HIS DIABETES WITH INSULIN WHICH HE SELF- ADJUSTS. THE REPORTER STATED THAT AFTER OBTAINING THE ¿HIGH¿ RESULT, THE PATIENT TESTED HIS BLOOD GLUCOSE LEVELS AT 8:08 PM AND 8:13 PM, OBTAINING READINGS OF ¿463 MG/DL¿ AND ¿277 MG/DL¿, RESPECTIVELY. THE REPORTER INDICATED THAT AT 8:13 PM, THE PATIENT ADMINISTERED AN INCREASED INSULIN DOSE (EXACT BRAND/DOSE NOT KNOWN BY REPORTER). THE REPORTER STATED THAT SOMETIME AFTER ADMINISTERING THE INSULIN, THE PATIENT ¿FELT FAINT¿ WITH SYMPTOMS OF ¿TREMBLING AND SWEATING¿. SHE REPORTED THAT THE PATIENT SELF-TREATED HIS SYMPTOMS BY CONSUMING FOOD

  Patient problems: Shaking/Tremors; Sweating; Syncope

  MAUDE report 9309484 ↗