TRUE METRIXRecalls & reported problems across all models

We found 31 models of TRUE METRIX by Trividia Health, Inc. in the FDA's device registry (GUDID). Together they are named in 4,546 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and May 21, 2026 — classified as 6 deaths, 951 injuries, 3,589 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2,741 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

TRUE METRIX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 6, 2026Open, Classified

   The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

   Z-1545-2026 · Root cause: Software design · names 4 of these models · Recall details · FDA record ↗

2. Oct 7, 2025Open, Classified

   Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.

   Z-0413-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported TRUE METRIX problems

TRUE METRIX models

31 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test Strips

  Glucose Dehydrogenase, Glucose
  2 deaths2,548 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALE

  System, Test, Blood Glucose, Over The Counter
  418 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 30 Test Strips

  System, Test, Blood Glucose, Over The Counter
  3 deaths355 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

  System, Test, Blood Glucose, Over The Counter
  329 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALE

  System, Test, Blood Glucose, Over The Counter
  182 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter

  Glucose Dehydrogenase, Glucose
  95 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 25 Test Strips

  Glucose Dehydrogenase, Glucose
  1 death93 reports
• TRUE METRIX TRUE METRIX self monitoring blood glucose meter - FREE METER ONLY

  System, Test, Blood Glucose, Over The Counter
  82 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY

  System, Test, Blood Glucose, Over The Counter
  75 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter

  Glucose Dehydrogenase, Glucose
  65 reports
• TRUE METRIX sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

  System, Test, Blood Glucose, Over The Counter
  61 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter

  System, Test, Blood Glucose, Over The Counter
  1 recall6 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

  System, Test, Blood Glucose, Over The Counter
  1 recall5 reports
• TRUE METRIX TRUE METRIX self monitoring blood glucose meter

  Glucose Dehydrogenase, Glucose
  1 recall3 reports
• TRUE METRIX TRUE METRIX self monitoring blood glucose meter

  System, Test, Blood Glucose, Over The Counter
  1 recall0 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter

  Glucose Dehydrogenase, Glucose
  1 recall0 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter – FREE METER ONLY

  System, Test, Blood Glucose, Over The Counter
  43 reports
• TRUE METRIX TRUE METRIX self monitoring blood glucose meter

  System, Test, Blood Glucose, Over The Counter
  30 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Test Strips

  Glucose Dehydrogenase, Glucose
  23 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY

  System, Test, Blood Glucose, Over The Counter
  23 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter

  System, Test, Blood Glucose, Over The Counter
  20 reports
• TRUE METRIX TRUE METRIX self monitoring blood glucose meter

  System, Test, Blood Glucose, Over The Counter
  19 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter

  System, Test, Blood Glucose, Over The Counter
  17 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY

  System, Test, Blood Glucose, Over The Counter
  13 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

  System, Test, Blood Glucose, Over The Counter
  12 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 10 Test Strips

  Glucose Dehydrogenase, Glucose
  11 reports
• TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter

  System, Test, Blood Glucose, Over The Counter
  8 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

  System, Test, Blood Glucose, Over The Counter
  4 reports
• TRUE METRIX TRUE METRIX Control Solution Level 1

  Single (Specified) Analyte Controls (Assayed And Unassayed)
  3 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

  System, Test, Blood Glucose, Over The Counter
  2 reports
• TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER

  Glucose Dehydrogenase, Glucose
  1 report

Recent TRUE METRIX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026High Test Results

  CONSUMER HAD INITIALLY REPORTED COMPLAINT FOR METER ERROR MESSAGE (E-3). CUSTOMER STATED THAT SHE HAD A FOLLOW-UP DOCTOR APPOINTMENT AND HAD BROUGHT THE TRUE METRIX METER AS SHE HAD OBTAINED THE E-3 ERROR MESSAGE. CUSTOMER STATED SHE HAD TESTED AT THE DOCTOR'S OFFICE AND HAD OBTAINED A RESULT OF 131 MG/DL, THE SAME RESULT WHEN SHE TESTS AT HOME. WHEN CUSTOMER HAD GONE INTO THE METER MEMORY TO FIND THE RESULTS OF 131 MG/DL, CUSTOMER STATED THE METER DISPLAYED 666, 600 AND ALSO HI ON 04/23 AT 2:27 PM. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. 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 LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/25/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 2-3 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241822 ↗
• MalfunctionMay 21, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 276 MG/DL. THE CUSTOMER STATED HER EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-140 MG/DL. CUSTOMER STATED THAT SHE HAS ONLY BEEN USING THE METER FOR LESS THAN A MONTH. 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 NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/16/2027 AND THE 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: 276 MG/DL DATE: (B)(6) 2026 TIME: 8:17AM FASTING AM. RESULT 2: 131 MG/DL DATE: (B)(6) 2026 TIME: 8:14PM FASTING PM. RESULT 3: 139 MG/DL DATE: (B)(6) 2026 TIME: 8:09PM FASTING PM. RESULT 4: 96 MG/DL DATE: (B)(6) 2026 TIME: 12:38PM FASTING PM. RESULT 5: 123 MG/DL DATE: (B)(6) 2026 TIME: 7:27AM F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241428 ↗
• MalfunctionMay 15, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 141, 228, 149 AND 218 MG/DL. THE CUSTOMER STATED HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 98-125 MG/DL AM FASTING AND BELOW 160 MG/DL 2 HRS. AFTER MEALS. 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 125 MG/DL AND 128 MG/DL USING TRUE METRIX METER. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/19/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS ABOUT MONTH AND A HALF AGO THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 141 MG/DL DATE: (B)(6) 2026 TIME: 10:30 AM 2 HRS. AFTER MEAL RESULT 2: 228 MG/DL DATE: (B)(6) 2026 TIME: 10:27 AM 2 HRS. AFTER MEAL RESULT 3: 149 MG/DL DATE: (B)(6) 2026 TIME: 5:02 AM FASTING. RESULT 4: 218 MG/DL DATE: (B)(6) 2026 TIME: 5:00 AM FASTING RESULT 5: 110 MG/DL DATE: (B)(6) 2026 TI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191304 ↗
• MalfunctionMay 8, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 212, 315, 245, 243, AND 366 MG/DL. CALLER STATED THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS FASTING 80-97 MG/DL AM, AND EVENING - 1 HR. AFTER EATING - PM 196-216 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 BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PER CALLER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE CLOSET. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2027 AND PER THE CALLER THE OPEN VIAL DATE IS 1 WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 212 MG/DL DATE: (B)(6) TIME: 9:46AM FASTING , RESULT 2: 315 MG/DL DATE: (B)(6) TIME: 11:05PM NON-FASTING , RESULT 3: 245 MG/DL DATE: (B)(6) TIME: 9:53AM FASTING , RESULT 4: 243 MG/DL DATE: (B)(6) TIME: 9:57AM FASTING, RESULT 5: 366 MG/DL DATE: (B)(6) TIME: 10:48PM NON-FASTING, RESULT 6: 54 MG/DL DATE: (B)(6) TIME: 9:47AM FASTING (CUSTOMER WAS NOT CONCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125388 ↗
• InjuryMay 7, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO INQUIRED AS TO WHAT IS THE E-5 LABELING CORRECTION LETTER; CUSTOMER STATED THEY HAVE NOT SEEN THAT IN THE METER. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS FEELING FATIGUE, AND SLOW TO SPEAK. CUSTOMER SON STATED SHE DOES NOT NEED TO SEEK MEDICAL INTERVENTION AT THIS TIME. CUSTOMER UNABLE TO TROUBLESHOOT. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Fatigue; Speech Disorder

  MAUDE report 25117000 ↗
• MalfunctionMay 7, 2026Imprecise or Erratic Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 65, 68, 64, 61 AND 97 MG/DL. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE BELOW 100 MG/DL AM FASTING AND BELOW 180 MG/DL 2 HRS. POST MEAL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER ADVISED THAT ON (B)(6) 2026 WHEN SHE WAS GETTING THE LOW RESULTS (NO SYMPTOMS), SHE HAD CALLED HER DOCTOR TO ASK WHAT SHE SHOULD DO. PER CUSTOMER HER DOCTOR ADVISED HER THAT IF SHE IS NOT HAVING SYMPTOMS TO GO WITH THE HIGHER OF THE RESULT AND IF SHE IS HAVING SYMPTOMS TO GO WITH THE LOWER RESULT. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER PM FASTING AND PRODUCED TEST RESULTS OF 62 MG/DL AND 65 MG/DL USING TRUE METRIX AIR METER. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 65 MG/DL DATE: (B)(6) 2026 TIME: 2:24 PM UNSURE. RESULT 2: 68 MG/DL DATE: (B)(6) /2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116381 ↗
• MalfunctionMay 7, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER DOES NOT KNOW HIS 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 HI USING TRUE METRIX AIR METER. PER CUSTOMER, THE PRODUCT IS STORED OUTSIDE OF THE KITCHEN. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/15/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 04/2026. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: HI MG/DL DATE: 4/13 TIME: 5:39PM FASTING. RESULT 2: HI MG/DL DATE: 4/13 TIME: 5:09PM FASTING. RESULT 3: 425 MG/DL DATE: 4/13 TIME: 1:49PM NON-FASTING. RESULT 4: 335 MG/DL DATE: 4/13 TIME: 11:44AM FASTING. RESULT 5: 408 MG/DL DATE: 4/13 TIME: 11:25AM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116064 ↗
• InjuryMay 7, 2026Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-2). NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CALLER ADVISED THE CUSTOMER HAD SYMPTOMS OF HYPOGLYCEMIA (WEAKNESS) THE DAY PRIOR, (B)(6) 2026, AND WAS TAKEN TO THE HOSPITAL. THE DIAGNOSIS WAS HIGH BLOOD GLUCOSE. CALLER DID NOT DISCLOSE WHAT TREATMENT CUSTOMER HAD RECEIVED. CUSTOMER HAD BEEN DISCHARGED THE DAY OF THE CALL, (B)(6) 2026. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PER CALLER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/29/2027 AND PER CALLER THE OPEN VIAL DATE IS 2 WEEKS AGO. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY.

  Patient problems: Hyperglycemia; Muscle Weakness/Atrophy

  MAUDE report 25112983 ↗
• MalfunctionMay 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE AND CONTROL TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM BLOOD GLUCOSE TEST RESULT OBTAINED OF 248 MG/DL AND CONTROL TEST RESULT OF 79 MG/DL. PER CALLER THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125-145 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 ON THE DINING ROOM TABLE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2027 AND PER THE CALLER THE OPEN VIAL DATE IS (B)(6) 2026. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 248 MG/DL DATE:(B)(6) TIME:4:47P UNKNOWN. RESULT 2: 180 MG/DL DATE:(B)(6) TIME:04:26P UNKNOWN (DAUGHTER'S RESULT). RESULT 3: 79 MG/DL DATE:(B)(6) TIME:4:52P CONTROL TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112100 ↗
• MalfunctionMay 7, 2026Physical Resistance/Sticking

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS AND PHYSICAL DEFECT OF TEST STRIPS. CUSTOMER STATED THAT SHE HAS 4 VIALS OF THE SAME LOT NUMBER OF TEST STRIPS AND ALL OF THEM ARE STICKING TOGETHER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT SHE PERFORMED A BLOOD TEST USING THE TRUE METRIX GO METER AND ONE OF THE TEST STRIP VIALS AND OBTAINED A RESULT OF OVER 500 MG/DL. CUSTOMER STATED THAT SHE WENT TO THE URGENT CLINIC; CUSTOMER'S BLOOD GLUCOSE TEST RESULT AT THE CLINIC HAD BEEN IN THE 140S (CUSTOMER DID NOT RECALL THE EXACT RESULT). CUSTOMER HAD BEEN DISCHARGED THE SAME DAY, (B)(6) 2026. THE CUSTOMER HAD REPORTED THE SAME COMPLAINT IN (B)(6) 2025: INTERNAL REPORT REFERENCE NUMBER (B)(4). 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 08/18/2026 AND THE OPEN VIAL DATE WAS NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111671 ↗
• MalfunctionMay 7, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 207, 154 AND 218 MG/DL. CALLER STATED THE CUSTOMER'S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-125 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 NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/16/2027 AND THE 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: 207 MG/DL DATE: (B)(6) 2026 TIME: 4:12PM NON-FASTING PM RESULT 2 :154 MG/DL DATE: (B)(6) 2026 TIME: 7:30AM FASTING AM RESULT 3: 218 MG/DL DATE: (B)(6) 2026 TIME: 7:22AM FASTING AM RESULT 4: 83 MG/DL DATE: (B)(6) 2026 TIME: 7:20AM FASTING AM RESULT 5: 97 MG/DL DATE: (B)(6) 2026 TIME: 7:30AM FASTING AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111177 ↗
• MalfunctionMay 1, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 159, 222, 236, 279 AND 173 MG/DL. THE CUSTOMER STATED HER EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 140 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 NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/18/2027 AND THE 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: 159MG/DL DATE: (B)(6) 2026 TIME: 10:43AM FASTING AM. RESULT 2: 119MG/DL DATE: (B)(6) 2026 TIME: 6:28PM FASTING PM. RESULT 3: 222MG/DL DATE: (B)(6) 2026 TIME: 11:10AM FASTING AM. RESULT 4: 236MG/DL DATE: (B)(6) 2026 TIME: 11:25PM FASTING PM. RESULT 5: 279MG/DL DATE: (B)(6) 2026 TIME: 10:24PM FASTING PM. RESULT 6: 173MG/DL DATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056140 ↗
• MalfunctionMay 1, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 214, 203, 248 AND 227 MG/DL. THE CUSTOMER STATED HER EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 104-115 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 04/29/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 214 MG/DL, DATE: ON (B)(6), TIME: 2:51AM FASTING. RESULT 2: 203 MG/DL, DATE: ON (B)(6), TIME: 5:09PM UNKNOWN. RESULT 3: 248 MG/DL, DATE: ON (B)(6), TIME: 10:45AM FASTING. RESULT 4: 227 MG/DL, DATE: ON (B)(6), TIME: 10:43AM FASTING. RESULT 5: 107 MG/DL, DATE: ON (B)(6), TIME: 9:37AM FASTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055932 ↗
• MalfunctionMay 1, 2026Imprecise or Erratic Results

  CONSUMER HAD INITIALLY REPORTED COMPLAINT FOR ERROR MESSAGE (E-5). DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AM FASTING AND PRODUCED TEST RESULTS OF 94 MG/DL AND 349 MG/DL USING TRUE METRIX METER. CUSTOMER WAS CONCERNED THAT THE RESULTS WERE ERRATIC. CUSTOMER ALSO STATED THAT HE HAD BLOOD WORK DONE FOR A PROCEDURE (NOT RELATED TO DIABETES) 30 MINUTES PRIOR AND THE RESULT HAD BEEN 315 MG/DL FASTING. THE CUSTOMER DOES NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER REPORTED FEELING FATIGUED; PER CUSTOMER IT IS AN ONGOING SYMPTOM. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/28/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS(B)(6) 2026. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue; Polydipsia; Swelling/ Edema

  MAUDE report 25055656 ↗
• MalfunctionApr 27, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM METER TO LAB COMPARISON OF 142 MG/DL USING TRUE METRIX METER AND LAB RESULT OF 107 MG/DL PERFORMED (B)(6) 2025 AM FASTING. THE CUSTOMER STATED HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 95-100 MG/DL AM FASTING. 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 NON-FASTING AND PRODUCED TEST RESULT OF 162 MG/DL USING TRUE METRIX METER. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/31/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE IS FEW WEEKS AGO. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998633 ↗

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