TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,548 adverse event reports that list this exact device (DI 00021292007836), received between Nov 18, 2016 and May 21, 2026 — classified as 2 deaths, 725 injuries, 1,821 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1,537 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 2,548 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 21, 2026Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THEY WERE GETTING E-3 AND COULDN'T GET A READING, SO THEY ENDED UP CALLING 911 ON THE DAY OF THE CALL. WHEN PARAMEDICS WERE THERE, THEY OPENED ANOTHER BOTTLE OF TEST STRIPS WITH THE SAME LOT NUMBER, BUT THEY WERE STILL GETTING THE E-3 WITH THE NEW VIAL. PARAMEDICS WERE ABLE TO TEST WITH THEIR OWN EQUIPMENT AND GET A READING (UNDISCLOSED READING). DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/30/2026; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947709 ↗
• InjuryApr 17, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS USING REPLACEMENT PRODUCTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 182, 152 AND 135 MG/DL AM FASTING. THE CUSTOMER STATED HIS EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 118-120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED HE CALLED HIS DOCTOR'S OFFICE LAST WEEK (DID NOT REMEMBER THE DATE) AND HAS AN APPOINTMENT LATER THIS WEEK WITH HIS DOCTOR TO TALK ABOUT THE RESULTS ON THE METER. 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 (BATHROOM). 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 NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912615 ↗
• MalfunctionApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR OUT-OF-RANGE CONTROL TEST RESULT. CUSTOMER ALSO REPORTED THAT THE RESULTS FROM HER BLOOD TESTS ARE ALWAYS THE SAME, 90 MG/DL FASTING. THE CUSTOMER'S EXPECTED 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. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/20/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 90 MG/DL, DATE: (B)(6), TIME: 4:44A FASTING, RESULT 2: 90 MG/DL , DATE: (B)(6), TIME: 4:21A FASTING, RESULT 3: 90 MG/DL, DATE: (B)(6), TIME: 5:15A FASTING , RESULT 4: 90 MG/DL , DATE: (B)(6), TIME: 5:10A FASTING, RESULT 5 90 MG/DL, DATE: (B)(6), TIME: 2:18P CONTROL TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843772 ↗
• MalfunctionApr 9, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 284, 314, 383, 252 AND 386 MG/DL. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEST RESULT IS 140 MG/DL OR UNDER AM FASTING AND 2-HOURS POST MEAL PM. THE CUSTOMER REPORTED EXPERIENCING CHEST PALPITATIONS; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. 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 06/23/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 284 MG/DL DATE: (B)(6) 2026 TIME: 8:52AM NON-FASTING AM RESULT 2: 314 MG/DL DATE: (B)(6) 2026 TIME: 7:29AM NON-FASTING AM RESULT 3: 383 MG/DL DATE: (B)(6) 2026 TIME: 6:42AM FASTING AM RESULT 4: 252MG/DL DATE: (B)(6) 2026 TIME: 3:28AM FASTING AM RESULT 5: 386 MG/DL DATE: (B)(6) 2026 TIME: 4:22PM FASTING PM.

  Patient problems: Arrhythmia

  MAUDE report 24834919 ↗
• MalfunctionApr 8, 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 464, 293, 257, 462 AND 269 MG/DL. THE CUSTOMER STATED HIS EXPECTED BLOOD GLUCOSE TEST RESULT IS UNDER 140 MG/DL FASTING AM. 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 486 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 10/31/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 464 MG/DL DATE: (B)(6) 2026 TIME:608AM FASTING AM, RESULT 2: 293 MG/DL DATE: (B)(6) 2026 TIME:557AM FASTING AM , RESULT 3: 257 MG/DL DATE: (B)(6) 2026 TIME: 524AM FASTING AM, RESULT 4: 462 MG/DL DATE: (B)(6) 2026 TIME: 340AM FASTING AM , RESULT 5: 269 MG/DL DATE: (B)(6) 2026 TIME: 556AM FASTING AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815056 ↗
• InjuryApr 7, 2026Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 46, 47, 48, 77 MG/DL. THE CUSTOMER STATED HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 111-119 MG/DL FASTING AM. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CAREGIVER ADVISE THE CUSTOMER GOT EXTREMELY LOW RESULT (48MG/DL FASTING AM) ON (B)(6) 2026. CAREGIVER GAVE THE CUSTOMER SOME HONEY AND ORANGE JUICE RETEST A 37 MINUTES LATER GOT A RESULT OF 47 MG/DL AND AS A RESULT HE CALLED THE PARAMEDICS WHICH CAME OUT TO THE HOME AT WHICH TIME THEY TESTED THE CUSTOMER'S BLOOD SUGAR AND GOT A RESULT 113 MG/DL NON-FASTING AND CUSTOMER'S METER TESTED AT 83 MG/DL NON-FASTING. CAREGIVER ADVISED HE TOOK THE CUSTOMER TO THE DR. FOR AN ISSUE NOT RELATED TO DIABETES ABOUT A WEEK AND A HALF GO (HE COULD NOT RECALL THE DATE OF THE DR VISIT) AND STATED HE MENTIONED TO THE DR THE METER IS NOT WORKING AND WAS GIVEN A TEMPORARY METER TO USE UNTIL HE COULD GET IN TOUCH WITH THE MANUFACTURER. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PER CUSTOMER, THE PRODUCT IS STORED ACCORD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809722 ↗
• MalfunctionApr 7, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGES (E-2 AND E-3). THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 140-150 MG DL FASTING AM. 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 139 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 08/17/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS THE DAY OF THE CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 1 RESULT PROVIDED): RESULT 1: HI DATE: (B)(6) 2026 TIME:322PM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809251 ↗
• InjuryApr 7, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO CALLED ABOUT E-5 LABELING CORRECTION. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER STATED HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 60-90 MG/DL FASTING. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CALLER STATED SHE IS CONCERNED THE CUSTOMER'S METER IS SHOWING HIGH AND LOW RESULTS, IT WILL SHOW HIGH RESULTS ONE MORNING, THEN LOW THE NEXT. CALLER STATED THEY WENT TO A ROUTINE APPT ON (B)(6) 2026 AND THE DOCTOR CHANGED HIS MEDICATION. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/19/2027 AND CUSTOMER STATED THEY DID NOT REMEMBER WHEN THE TEST STRIPS WERE OPEN. CUSTOMER STATED SHE WILL CALL HIS DOCTOR TO SEE IF THEY SHOULD STOP THE METFORMIN WHILE HE IS WAITING FOR THE METER. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807705 ↗
• InjuryApr 3, 2026Imprecise or Erratic Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 402, 228, 230 AND 178 MG/DL. CUSTOMER ADVISED THAT THE RESULTS FROM THE MEMORY OF THE METER WERE TAKEN ONE RIGHT AFTER THE OTHER WITHIN 2 MINUTES OF EACH OTHER. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER REPORTED FEELING SHAKY AND WEAK; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 249 MG/DL AND 241 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 04/30/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 402 MG/DL DATE: (B)(6) 2026 TIME: AM NON-FASTING. RESULT 2: 228 MG/DL DATE: (B)(6) 2026 TIME: AM NON-FASTING . RESULT 3: 230 MG/DL DATE: (B)(6) 2026 TIME: AM NON-FASTING . RESULT 4: 178 MG/DL DATE: (B)(6) 2026 TIME: AM NON-FASTING.

  Patient problems: Muscle Weakness/Atrophy; Shaking/Tremors

  MAUDE report 24778387 ↗
• InjuryApr 2, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO CALLED REGARDING E-5 CORRECTION LETTER SHE RECEIVED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER ADVISED THAT ON (B)(6) 2026 WHEN SHE TESTED IN THE MORNING, HER BLOOD GLUCOSE WAS 304 MG/DL FASTING; SHE STATED THAT SHE WAS SWEATING AND FEELING DIZZY, SO SHE CALLED 911 AND WAS TAKEN TO THE HOSPITAL. CUSTOMER COULD NOT ADVISE WHAT HER BLOOD GLUCOSE LEVEL WAS WHEN SHE WENT TO THE HOSPITAL. CUSTOMER WAS NOT ADMITTED BUT DISCHARGED THE SAME MORNING WITH A BLOOD GLUCOSE OF 173 MG/DL (UNDISCLOSED FASTING/NON-FASTING AND ADVISED TO FOLLOW-UP WITH HER PCP. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 241 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Diaphoresis; Dizziness; Hyperglycemia

  MAUDE report 24767151 ↗
• MalfunctionMar 31, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM ALL METER MEMORY RESULTS PROVIDED. THE CUSTOMER STATED HER EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-125MG/DL. CUSTOMER ALSO STATED THAT IF HER GLUCOSE IS OVER 125-140MG/DL, SHE IS SUPPOSED TO CHECK WITH HER DOCTOR BECAUSE SHE IS NOT TAKING DIABETIC MEDICATION. 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 04/30/2027 AND CUSTOMER COULD NOT REMEMBER THE OPEN VIAL DATE. 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: 129MG/DL DATE: UNSURE TIME: UNSURE FASTING AM, RESULT 2: 118MG/DL DATE: UNSURE TIME: UNSURE FASTING AM , RESULT 3: 138MG/DL DATE: UNSURE TIME: UNSURE FASTING AM , RESULT 4: 171MG/DL DATE: UNSURE TIME: UNSURE FASTING AM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750127 ↗
• InjuryMar 31, 2026Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. ON (B)(6) 2026 CUSTOMER STATED HE WAS NOT FEELING WELL, HE WAS VOMITING AND FELT HIS BLOOD GLUCOSE WAS HIGH. CUSTOMER STATED HE TESTED HIS BLOOD GLUCOSE WITH THE TRUE METRIX AND OBTAINED A RESULT OF 230 MG/DL (DID NOT DISCLOSE IF FASTING OR NON-FASTING) AND WENT TO THE ER DUE TO THE SYMPTOMS. CUSTOMER STATED HE WAS TESTED THERE WITH THEIR METER, AND THE RESULT WAS 510 MG/DL (NOT DISCLOSED IF FASTING OR NON-FASTING). THE CUSTOMER DID NOT RECALL HOW LONG BETWEEN WHEN HE TESTED WITH THE TRUE METRIX AND THE TEST DONE AT THE ER. THE DIAGNOSIS WAS HIGH BLOOD GLUCOSE AND CUSTOMER WAS GIVEN A SHOT. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; THE METER IMMEDIATELY GOT TO E-3 WITH CLEAN TEST STRIP. PER CUSTOMER, THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/17/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 MONTH AGO.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 24749639 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED IN TO GET SOME INFORMATION ON THE USE OF THE METER AND RANGES FOR TESTING AS HE IS A NEWLY DIAGNOSED DIABETIC. CUSTOMER ADVISED THAT HE IS FEELING SLUGGISH BUT DECLINED THE NEED FOR ANY MEDICAL INTERVENTION AT THIS TIME AND WAS ABLE TO PROCEED WITH THE CALL. CUSTOMER WAS ADVISED OF PROVIDED RANGES FOR NON-DIABETICS AS NOTED IN THE THI IFU MANUAL AND ALSO WITH INFORMATION REGARDING CLINICALLY LOW/HIGH RESULTS. CUSTOMER SATISFIED WITH THE EXPLANATION GIVEN AND IS NOT CONCERNED WITH THE READING AT THIS TIME.

  Patient problems: Lethargy; Stroke/CVA

  MAUDE report 24746931 ↗