TRUENESS TRUENESS Blood Glucose Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00021292015084), received between Jul 9, 2025 and Mar 11, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR CONTROL RESULT OUT OF CONTROL RANGE AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 123, 146, 110 AND 160 MG/DL. THE CUSTOMER STATED HIS EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/20/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 4 RESULTS PROVIDED): RESULT 1: 123 MG/DL DATE: ON (B)(6) 2026 TIME: 5:38 PM, NON-FASTING. RESULT 2: 146 MG/DL DATE: ON (B)(6) 2026 TIME: 5:27 PM, NON-FASTING. RESULT 3: 110 MG/DL DATE: ON (B)(6) 2026 TIME: 9:25 PM, NON-FASTING. RESULT 4: 160 MG/DL DATE: ON (B)(6) 2026 TIME: 9:23 PM, NON-FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571184 ↗
• MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR CONTROL RESULT OUT OF CONTROL RANGE AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 123, 146, 110 AND 160 MG/DL. THE CUSTOMER STATED HIS EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS, DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/20/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 4 RESULTS PROVIDED) RESULT: 1: 123 MG/DL DATE: (B)(6) 2026 TIME: 5:38 PM NON-FASTING RESULT 2: 146 MG/DL DATE: (B)(6) 2026 TIME: 5:27 PM NON-FASTING RESULT 3: 110 MG/DL DATE: (B)(6) 2026 TIME: 9:25 PM NON-FASTING RESULT 4: 160 MG/DL DATE: (B)(6) 2026 TIME: 9:23 PM NON-FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452047 ↗
• MalfunctionFeb 25, 2026Imprecise or Erratic Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM BACK-TO-BACK TEST RESULTS OF 93 AND 203 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 164 MG/DL USING TRUENESS METER. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/22/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 09/2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 231 MG/DL, DATE: (B)(6) 2026 , TIME: 11:49AM FASTING (ATE 2 HR. PRIOR), RESULT 2: 277 MG/DL, DATE: (B)(6) 2026 , TIME: 11:47AM FASTING , RESULT 3: 289 MG/DL , DATE: (B)(6) 2026 , TIME: 11:46AM FASTING , RESULT 4: 231MG/DL, DATE: (B)(6) 2026 , TIME: 1:17PM NON-FASTING , RESULT 5: 311 MG/DL , DATE: (B)(6) 2026, TIME: 1:16PM NON-FASTING , RESULT 6: 93 MG/DL , DATE: (B)(6) 2026 ,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447302 ↗
• MalfunctionFeb 9, 2026Imprecise or Erratic Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER.THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM BACK-TO-BACK TEST RESULTS OF 93 AND 203 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE.THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 164 MG/DL USING TRUENESS METER, PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM, THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE IS (B)(6) 2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 231 MG/DL DATE: (B)(6) 2026 TIME: 11:49AM FASTING (ATE 2 HR. PRIOR) RESULT 2: 277 MG/DL DATE: (B)(6) 2026 TIME: 11:47AM FASTING RESULT 3: 289 MG/DL DATE: (B)(6) 2026 TIME: 11:46AM FASTING RESULT 4: 231MG/DL DATE: (B)(6) 2026 TIME: 1:17PM NON-FASTING RESULT 5: 311 MG/DL DATE: (B)(6) 2026 TIME: 1:16PM NON-FASTING RESULT 6: 93 MG/DL DATE: (B)(6) 2026 TIME: 1:45PM NON FASTING R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289337 ↗
• MalfunctionNov 28, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 162 MG/DL. THE CUSTOMERS' EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6) 2026 AND OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 112 MG/DL DATE: (B)(6) 2025 TIME: 7:44AM FASTING AM RESULT 2: 132 MG/DL DATE: (B)(6) 2025 TIME: 8:33AM FASTING AM RESULT 3: 104 MG/DL DATE: (B)(6) 2025 TIME: 7:19AM FASTING AM RESULT 4: 132 MG/DL DATE: (B)(6) 2025 TIME: 8:16AM FASTING AM RESULT 5: 138 MG/DL DATE: (B)(6) 2025 TIME: 9:32AM FASTING AM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23675559 ↗
• MalfunctionNov 28, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 122, 118 AND 124 MG/DL. THE CUSTOMER'S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-100 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2026 AND OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 3 RESULTS PROVIDED): RESULT 1: 122 MG/DL DATE: (B)(6) 2025 TIME: 8:09 AM FASTING RESULT 2: 118 MG/DL DATE: (B)(6) 2025 TIME: 7:58 AM FASTING RESULT 3: 124 MG/DL DATE: (B)(6) 2025 TIME: 9:44 AM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23675557 ↗
• MalfunctionNov 26, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 162 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/27/2026 AND OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 112 MG/DL, DATE: (B)(6) 2025, TIME: 7:44AM FASTING AM. RESULT 2: 132 MG/DL, DATE:(B)(6) 2025, TIME: 8:33AM FASTING AM. RESULT 3: 104 MG/DL DATE: (B)(6) 2025, TIME: 7:19AM FASTING AM. RESULT 4: 132 MG/DL DATE:(B)(6) 2025, TIME: 8:16AM FASTING AM. RESULT 5: 138 MG/DL DATE: (B)(6) 2025, TIME: 9:32AM FASTING AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656613 ↗
• MalfunctionNov 26, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 122, 118 AND 124 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-100 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/22/2026 AND OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 3 RESULTS PROVIDED): RESULT 1: 122 MG/DL DATE: (B)(6) 2025 TIME: 8:09 AM FASTING RESULT 2: 118 MG/DL DATE: (B)(6) 2025 TIME: 7:58 AM FASTING RESULT 3: 124 MG/DL DATE: (B)(6) 2025 TIME: 9:44 AM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656448 ↗
• MalfunctionNov 19, 2025Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. CUSTOMER STATED SHE OBTAINED THE LO ABOUT 20-30 MINUTES AFTER EATING. CUSTOMER STATED SHE PERFORMED A BLOOD TEST USING ANOTHER DEVICE AND OBTAINED A RESULT OF 161 MG/DL NON-FASTING. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/02/2027 AND OPEN VIAL DATE IS (B)(6) 2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: LO DATE: (B)(6), TIME: 7:06PM, NON-FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598254 ↗
• MalfunctionNov 3, 2025Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. CUSTOMER STATED SHE OBTAINED THE LO ABOUT 20-30 MINUTES AFTER EATING. CUSTOMER STATED SHE PERFORMED A BLOOD TEST USING ANOTHER DEVICE AND OBTAINED A RESULT OF 161 MG/DL NON-FASTING. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/02/2027 AND OPEN VIAL DATE IS 10/17/2025. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: LO DATE: 12/23 TIME: 7:06PM NON-FASTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447544 ↗
• MalfunctionOct 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 122, 123, 107, 126 AND 93 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/03/2026 AND OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 122 MG/DL DATE: ON (B)(6) 2025 TIME: 9:14AM FASTING AM RESULT 2: 123 MG/DL DATE: ON (B)(6) 2025 TIME: 4:52PM FASTING AM RESULT 3: 107 MG/DL DATE: ON (B)(6) 2025 TIME: 9:22AM FASTING AM RESULT 4: 126 MG/DL DATE: ON (B)(6) 2025 TIME: 8:26AM FASTING AM RESULT 5: 93 MG/DL DATE: ON (B)(6) 2025 TIME: 8:07AM FASTING AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335113 ↗
• InjuryOct 20, 2025Image Display Error/Artifact; Image Display Error/Artifact

  A CONSUMER REPORTED A COMPLAINT REGARDING AN ERROR MESSAGE (E-7). THE CUSTOMER REPORTED FEELING SHAKY AND EXPERIENCING A HEADACHE, BUT MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATIONS IN THE LIVING ROOM. THE TEST STRIP LOT'S MANUFACTURER'S EXPIRATION DATE IS 07/19/2026, AND THE OPEN VIAL DATE WAS NOT PROVIDED. THE CUSTOMER ALSO ADVISED THAT HE PURCHASED 4 CONTAINERS OF TEST STRIPS AND MIXED THE CONTENTS OF THE CONTAINERS TOGETHER. HOWEVER, THE CUSTOMER STATED THAT THE ERROR OCCURRED BEFORE HE MIXED THE TEST STRIPS. THE CUSTOMER DECLINED TO RUN A BLOOD TEST DURING THE CALL.

  Patient problems: Headache; Shaking/Tremors

  MAUDE report 23335045 ↗
• InjuryOct 15, 2025Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-7). THE CUSTOMER REPORTED FEELING SHAKY AND HAVING A HEADACHE. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/19/2026 AND OPEN VIAL DATE WAS NOT PROVIDED. CUSTOMER ALSO ADVISED HE PURCHASED 4 CONTAINERS OF TEST STRIPS AND MIXED THE CONTAINERS TOGETHER. CUSTOMER STATED THE ERROR OCCURRED BEFORE HE MIXED THE TEST STRIPS. CUSTOMER DECLINED RUNNING A BLOOD TEST DURING THE CALL.

  Patient problems: Headache; Shaking/Tremors

  MAUDE report 23305353 ↗
• MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 122, 123, 107, 126 AND 93 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/03/2026 AND OPEN VIAL DATE IS 2 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 122 MG/DL DATE: (B)(6) 2025 TIME: 9:14AM FASTING AM. RESULT 2: 123 MG/DL DATE: (B)(6) 2025 TIME: 4:52PM FASTING AM . RESULT 3: 107 MG/DL DATE: (B)(6) 2025 TIME: 9:22AM FASTING AM . RESULT 4: 126 MG/DL DATE: (B)(6) 2025 TIME: 8:26AM FASTING AM. RESULT 5: 93 MG/DL DATE: (B)(6) 2025 TIME: 8:07AM FASTING AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304008 ↗
• MalfunctionJul 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS AND HIGH CONTROL TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH BLOOD TEST RESULTS FROM RESULTS OBTAINED OF 194 AND 177 MG/DL. CONTROL TEST PERFORMED PRIOR TO THE CALL PRODUCED RESULT OF 133 MG/DL. CONTROL TEST NOT WITHIN ACCEPTABLE RANGE OF 72-108 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-160 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. DAUGHTER STATED THAT EARLIER THE CUSTOMER HAD NOT BEEN FEELING WELL WHEN THE HIGH BLOOD GLUCOSE TEST RESULTS HAD BEEN OBTAINED; CUSTOMER HAD BEEN INCOHERENT BUT HAD DRANK JUICE AND THEN FELT BETTER. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/03/2026 AND OPEN VIAL DATE WAS NOT PROVIDED. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY: LOT NUMBER 4R6156, MANUFACTURER¿S EXPIRATION DATE IS 06/28/2026 AND OPENED ON DAY OF CALL. DURING THE CALL,

  Patient problems: Confusion/ Disorientation

  MAUDE report 22462303 ↗