TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 30 Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 00021292009120), received between Apr 21, 2017 and May 8, 2026 — classified as 3 deaths, 154 injuries, 198 malfunctions.

The most frequently reported specific device problem is “High Test Results” (180 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 355 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 21, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. CUSTOMER HAS DRY MOUTH BUT DECLINED THE NEED FOR ANY MEDICAL INTERVENTION AT THIS TIME. CUSTOMER ADVISED THAT SHE HAS NOT TAKEN HER ORAL MEDICATIONS OR HER INSULIN ALL DAY. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI USING TRUE METRIX GO METER. CUSTOMER ADVISED THAT SHE IS NOT CONCERNED WITH THE HI AS SHE HAS NOT TAKEN ANY MEDS TODAY. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/31/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dry Mouth

  MAUDE report 24947734 ↗
• MalfunctionApr 11, 2026Imprecise or Erratic Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM BACK-TO-BACK BLOOD TEST RESULTS OF 167 AND 91 MG/DL AM FASTING. THE CUSTOMER STATED HER EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 104-107 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 DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/31//2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 03/18/2026. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851534 ↗
• InjuryApr 6, 2026Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGE (E-3). WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM METER-TO-METER COMPARISON OF 169 MG/DL USING TRUE METRIX METER AND 210 MG/DL USING ANOTHER DEVICE (FASTING/NON-FASTING NOT PROVIDED). CALLER STATED THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 110 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CALLER STATED SHE THOUGHT CUSTOMER WAS HAVING A STROKE, SO SHE HAD TAKEN HIM TO THE HOSPITAL ON 03/05. PER CALLER WHEN THE DOCTOR SAW HIM, THE CUSTOMER'S GLUCOSE WAS HIGH; THE HOSPITAL'S METER SHOWED 210 MG/DL WHILE THE TRUE METRIX METER SHOWED 169 MG/DL. PER CALLER, THE CUSTOMER IS STILL IN THE HOSPITAL BEING MONITORED. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PER CALLER, 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 CALLER THE OPEN VIAL DATE IS 1 WEEK AGO. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia

  MAUDE report 24788622 ↗
• MalfunctionMar 23, 2026Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 88, 121, 171, 88 AND 96 MG/DL. PER CUSTOMER, SHE IS COMPARING RESULTS TO HER "OLD METER"; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE BELOW 100 MG/DL AM FASTING AND BELOW 170 MG/DL 2-HOURS POST MEAL. 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 2-HOURS POST MEAL AND PRODUCED TEST RESULTS OF 103 MG/DL AND 121 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 03/26/2027 AND PER THE CUSTOMER THE TEST STRIPS WERE OPENED 6 DAYS PRIOR TO THE CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 88 MG/DL , DATE: (B)(6) 2026 , TIME: 12:21 PM 2 HRS. AFTER MEAL, RESULT 2: 121 MG/DL, DATE: (B)(6) 2026 , TIME: 12:21 PM 2 HRS. AFTER MEAL, RESULT 3: 171 MG/DL , DA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662817 ↗
• MalfunctionMar 20, 2026Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-5). THE CUSTOMER REPORTED FEELING SYMPTOMS OF HUNGRY AND WEAK; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER STATED THAT SHE DID CALL HER DOCTOR'S THAT DAY AND TALKED TO THE NURSE ABOUT THE E-5 ERROR; PER CUSTOMER SHE HAD BEEN ADVISED TO SPEAK TO THE PHARMACY OR TO CONTACT THE MANUFACTURER. 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 05/31/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 2 WEEKS AGO.

  Patient problems: Increased Appetite; Muscle Weakness/Atrophy

  MAUDE report 24651733 ↗
• InjuryMar 17, 2026Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CALLER ADVISED THAT ON (B)(6) 2026, CUSTOMER GOT A RESULT OF 44 MG/DL NON-FASTING, AND SHE TOOK THE CUSTOMER TO THE ER. CUSTOMER WAS NOT HAVING ANY SYMPTOMS OF LOW BLOOD GLUCOSE WHEN THEY TOOK HER TO THE HOSPITAL. CALLER ADVISED THAT BEFORE TAKING THE CUSTOMER TO THE HOSPITAL, SHE GAVE HER CANDY. CALLER ADVISED THAT WHEN THE CUSTOMER GOT TO THE HOSPITAL, THE CUSTOMERS BLOOD GLUCOSE WAS IN THE 50'S (NON-FASTING, UNSURE OF ACTUAL RESULT). THE DIAGNOSIS WAS LOW BLOOD GLUCOSE. CALLER STATED THAT CUSTOMER WAS GIVEN ORANGE JUICE AND "OTHER THINGS" TO TRY TO BRING THE CUSTOMERS BLOOD GLUCOSE LEVELS UP. CUSTOMER WAS ADMITTED TO THE HOSPITAL AND RELEASED 2 DAYS LATER. CUSTOMERS DIABETIC MEDICATIONS WERE DECREASED (CALLER DID NOT SPECIFY). CUSTOMER WAS DISCHARGED AND ADVISED FOLLOWING UP WITH THEIR PCP. DURING THE CALL, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/29/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREV

  Patient problems: Hypoglycemia

  MAUDE report 24620785 ↗
• MalfunctionMar 13, 2026High Test Results; Imprecise or Erratic Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 130, 132 AND 244 MG/DL. CALLER STATED THE CUSTOMER'S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-110 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 CALLER THE PRODUCT IS BEING STORED OUTSIDE OF THE LARGE KITCHEN. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 1 WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME ON THE METER IS INCORRECT, ALL BLOODS WERE DONE IN THE AM): RESULT 1: 130 MG/DL, DATE: (B)(6), TIME: 12:02PM FASTING, RESULT 2: 93 MG/DL , DATE: (B)(6), TIME: 12:01PM FASTING, RESULT 3: 103 MG/DL , DATE: (B)(6), TIME: 12:15PM FASTING , RESULT 4: 98 MG/DL , DATE: (B)(6), TIME: 12:15PM FASTING, RESULT 5: 93 MG/DL , DATE: (B)(6), TIME: 12:03PM FASTING, RESULT 6: 132 MG/DL , DATE: (B)(6), TIME:12:01PM FASTING, R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594827 ↗
• MalfunctionMar 10, 2026Packaging Problem

  CONSUMER REPORTED COMPLAINT FOR LABELING ISSUE. THE CUSTOMER CALLED CONCERNED THAT THE TEST STRIP LOT NUMBER PRINTED ON THE BOX WAS DIFFERENT THAN THE LOT NUMBER OF THE VIAL THAT WAS ACTUALLY INSIDE OF THE BOX. PER CUSTOMER THE LOT NUMBER ON THE BOX WAS ZD6280 EXP 2027/5/27, AND THE LOT NUMBER OF THE ACTUAL VIAL INSIDE WAS ZC5743S EXP 2026/1/24. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560347 ↗
• MalfunctionMar 6, 2026Appropriate Device Problem Term/Code Not Available

  CONSUMER BELIEVES METER HAS BEEN USED (POSSIBLE TAMPERING) DUE TO RESULTS IN METER MEMORY THAT DO NOT BELONG TO THE CUSTOMER. THE CUSTOMER STATED HE HASN'T USED THE METER- HE JUST RECEIVED IT YESTERDAY AT WALGREENS. WHEN TRYING TO PAIR NOTICE THE METER HE NOTICED IT ALREADY CONTAINED RESULTS. CUSTOMER STATED THE BOX CAME SEALED (LIKE IT CAME FROM THE FACTORY) AND EVERYTHING WAS SEALED IN THE BOX. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE METER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/29/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: CUSTOMER PROVIDED THE RESULT OF: RESULT: 94MG/DL DATE: (B)(6) TIME: 8P. RESULT: 224MG/DL DATE: (B)(6) TIME: UNSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533131 ↗
• MalfunctionMar 6, 2026High Test Results

  CUSTOMER CALLED FOR ASSISTANCE RUNNING A BLOOD TEST. SHE TRIED 3 TIMES THIS MORNING AND THE RESULTS WERE HIGH AND ERRATIC. THE CUSTOMER WAS CONCERNED WITH THE TESTS RESULTS OBTAINED OF 96, 141 AND 113MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-90MG/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. PER CUSTOMER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/29/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 113 MG/DL DATE: ON (B)(6) TIME: 8:49AM FASTING. RESULT 2: 141 MG/DL DATE: ON (B)(6) TIME: 8:48AM FASTING. RESULT 3: 96 MG/DL DATE: ON (B)(6) TIME: 8:47AM FASTING. RESULT 4: 96 MG/DL DATE: ON (B)(6) TIME: 5:42PM 2HR AFTER MEAL. RESULT 5: 80 MG/DL DATE: ON (B)(6) TIME: 11:07PM BEDTIME/UNSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531659 ↗
• MalfunctionMar 6, 2026Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED WITH CONCERNED WITH THE TESTS RESULTS OBTAINED OF 74, 73 AND 52MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 94MG/DL NON FASTING AM AND 116MG/DL AFTER PM MEDICATION. CUSTOMER STATES THAT THE METER IS NOT MATCHING UP THE OLD METER (COMPARISON RESULTS 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. PER CUSTOMER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/15/2026 AND PER THE CUSTOMER THE OPEN VIAL DATE IS TWO DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 74 MG/DL DATE: (B)(6) 2026 TIME: 626AM NON-FASTING AM, (TOOK MEDS BEFORE TESTING) RESULT 2: 52 MG/DL DATE: (B)(6) 2026 TIME: 523PM NON-FASTING, (NO SYMPTOMS) RESULT 3: 73 MG/DL DATE: (B)(6) 2026 TIME: 803AM NON-FASTING, RESULT 4: 128 MG/DL DATE: (B)(6) 2026 TIME: 915PM NON-FASTING. RESULT 5: N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531402 ↗
• MalfunctionMar 4, 2026Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED WITH CONCERNED WITH THE TESTS RESULTS OBTAINED OF 64 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 81-121 MG/DL FASTING AM AND 200 MG/DL FASTING PM. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED SHE HAD CALLED HER DOCTOR ON (B)(6) 2026 BECAUSE OF A LOW RESULT IN HER METER OF 64 MG/DL FASTING AM. DOCTOR ADVISED HER TO RETAKE THE TEST (CUSTOMER DID NOT REMEMBER THE EXACT RESULT). CUSTOMER WENT TO THE PHARMACY, AND THEY ADVISED HER TO CALL US. CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT FROM THIS VIAL. DURING THE CALL ON (B)(6) 2026, 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 07/27/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 3 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT: 64 MG/DL, DATE: (B)(6), AND TIME: 12:22 FASTING AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506133 ↗
• MalfunctionMar 2, 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 209, 251 AND 222MG/DL. THE CUSTOMER STATED HIS EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-120 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 NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE WAS MONTHS AGO. 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 (PER CUSTOMER THE FIRST 3 READINGS WERE TAKEN SAME DAY BACK-TO-BACK WITHIN 5 MINUTES OF EACH OTHER): RESULT 1: 209MG/DL DATE: (B)(6) TIME: 9:35AM FASTING RESULT 2: 251MG/DL DATE: (B)(6) TIME: 10:15AM FASTING RESULT 3 :222 MG/DL DATE: (B)(6) TIME: 10:13AM FASTING RESULT 4: 115 MG/DL DATE: (B)(6) TIME: 4:31PM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24487940 ↗
• MalfunctionFeb 10, 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 154, 171, 163 AND 256 MG/DL. THE CUSTOMER STATED HIS EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-150 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 180 MG/DL AND 180 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 01/30/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 3 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 125 MG/DL DATE: (B)(6) 2026, TIME: 5:17 AM FASTING, RESULT 2: 154 MG/DL DATE: (B)(6) 2026, TIME: 4:30 AM FASTING, RESULT 3: 171 MG/DL DATE: (B)(6) 2026, TIME: 5:10 AM FASTING, RESULT 4: 163 MG/DL DATE: (B)(6) 2026, TIME: 4:38 AM FASTING, RESULT 5: 256 MG/DL DATE: (B)(6) 2026, TIME: 4:37 AM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308826 ↗
• MalfunctionFeb 5, 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 145, 174, 150, 158 AND 147 MG/DL. THE CUSTOMER STATED THEIR EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95-109 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 LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/29/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS <1 WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 145 MG/DL DATE: (B)(6), TIME: 9:49AM FASTING. RESULT 2: 174 MG/DL DATE: (B)(6), TIME: 9:37AM FASTING. RESULT 3: 150 MG/DL DATE: (B)(6), TIME: 9:35AM FASTING. RESULT 4: 158 MG/DL DATE: (B)(6), TIME: 9:30AM FASTING. RESULT 5: 147 MG/DL DATE: (B)(6), TIME: 7:24AM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270202 ↗
• MalfunctionJan 22, 2026High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED THE METER IS ONLY READING HI. 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF HI USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/29/2027; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER STATED HE WAS GOING TO TAKE MEDICATION DUE TO THE HI AND WAIT TO SEE IF IT GOES DOWN. CUSTOMER THEN DISCONNECTED THE CALL. MANUFACTURER ATTEMPTED TO CONTACT CUSTOMER TWICE; UNABLE TO ESTABLISH CONTACT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149148 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED IN TO RUN A BLOOD TEST. CUSTOMER ADVISED THAT HE IS FEELING DIZZY BUT DECLINED THE NEED FOR ANY MEDICAL INTERVENTION AT TIME. ATTEMPTED TO TRAIN CUSTOMER TO LOAD HIS LANCING DEVICE, HOWEVER, CUSTOMER WAS NOT ABLE TO FOLLOW ALONG WITH THE DIRECTIONS BEING GIVEN. CUSTOMER ADVISED THAT HE WILL GO TO THE VA IN THE MORNING (NOT BECAUSE OF SYMPTOMS) FOR THEM TO VISUALLY SHOW HIM HOW TO OPEN THE LANCING DEVICE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/27/2026; PRODUCT STORAGE AND OPEN VIAL DATE WERE NOT PROVIDED.

  Patient problems: Dizziness

  MAUDE report 24019618 ↗
• InjuryDec 30, 2025Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR DEAD METER; CUSTOMER INITIALLY ALSO REPORTED COMPLAINT FOR ERROR MESSAGES (UNKNOWN). COORDINATOR HAD SPOKEN WITH CUSTOMER AND TRANSFERRED INFORMATION TO TECHNICIAN. WHEN CONTACTED BY TECHNICIAN CUSTOMER CONFIRMED HE DID NOT RECEIVE ERROR MESSAGE. THE BATTERY IN THE METER HAD NOT BEEN CHANGED; PER THE CUSTOMER HE HAS ONLY HAD THE TRUE METRIX GO METER FOR TWO DAYS. THE CUSTOMER IS USING THE CORRECT BATTERY IN THE CORRECT ORIENTATION FOR THE METER. DURING THE CALL THE METER DID NOT POWER ON USING THE POWER BUTTON OR WHEN A TEST STRIP WAS INSERTED. THE CUSTOMER REPORTED FEELING WEAK; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 23921945 ↗
• MalfunctionDec 29, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 171, 159 AND 148 MG/DL. THE CUSTOMER STATED HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 80 MG/DL FASTING AM AND 130 MG/DL FASTING PM. 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 01/30/2027 AND PER THE CUSTOMER THE OPEN VIAL DATE IS 3 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 171MG/DL , DATE: (B)(6) 2025, TIME: 1:38PM FASTING PM , RESULT 2: 159MG/DL, DATE: (B)(6) 2025, TIME: 1:35PM FASTING PM, RESULT 3: 128MG/DL, DATE: (B)(6) 2025, TIME: 9:46AM FASTING AM, RESULT 4: 122MG/DL , DATE: (B)(6) 2025 , TIME: 9:45AM FASTING AM, RESULT 5: 148 MG/DL, DATE: (B)(6) 2025, TIME: 9:58AM FASTING AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908981 ↗
• MalfunctionDec 8, 2025High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 350 MG/DL. THE CUSTOMER STATED HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 80 MG/DL FASTING AM AND 150MG/DL FASTING PM. 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 10/30/2026 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 ONE RESULT PROVIDED): RESULT 1: 350 MG/DL DATE: (B)(6) TIME: 3:00P FASTING PM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751102 ↗
• InjuryDec 5, 2025High Test Results; High Test Results

  RESCUE SQUAD REPORTED COMPLAINT FOR HI AND HIGH BLOOD GLUCOSE TEST RESULTS. CALLER ALSO REPORTED COMPLAINT FOR CONTROL TEST RESULT OUT OF CONTROL RANGE. PER THE CALLER, THE TRUE METRIX GO METER HAD BEEN USED TO TEST A PATIENT AND A RESULT OF 434 MG/DL HAD BEEN OBTAINED (UNDISCLOSED IF FASTING OR NON-FASTING); THE PATIENT HAD BEEN RETESTED A MINUTE LATER AND THE METER READ HI (VERIFIED IN THE METER MEMORY). THE PATIENT HAD NOT BEEN EXPERIENCING ANY SYMPTOMS AT THE TIME; THE PATIENT HAS A MENTAL ILLNESS, AND THEIR BLOOD GLUCOSE HAD BEEN TESTED AS PER PROCEDURE. DUE TO THE HIGH AND HI RESULTS THE PATIENT HAD BEEN TAKEN TO THE ER ON (B)(6) 2025. THE PATIENT¿S BLOOD GLUCOSE LAB RESULT WHEN AT THE ER HAD BEEN 127 MG/DL (UNDISCLOSED IF FASTING OR NON-FASTING). CALLER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION AS TO WHAT TRANSPIRED AFTER THE RESCUE SQUAD HAD LEFT THE HOSPITAL BUT DID STATE THAT THE PATIENT HAD BEEN TREATED FOR SEPSIS. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2026 AND PER THE CALLER THE OPEN VIAL DATE IS LESS THAN 30 DAYS. THE CALLER STATED HE IS NOT SURE WHICH OF THE 3 TEST STRIP LOT NUMBERS HAD BEEN USED WHEN THE HIGH AND HI RESULTS HAD BEEN OBTAIN

  Patient problems: Sepsis; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 23733238 ↗
• InjuryDec 5, 2025High Test Results; High Test Results

  RESCUE SQUAD REPORTED COMPLAINT FOR HI AND HIGH BLOOD GLUCOSE TEST RESULTS. CALLER ALSO REPORTED COMPLAINT FOR CONTROL TEST RESULT OUT OF CONTROL RANGE. PER THE CALLER, THE TRUE METRIX GO METER HAD BEEN USED TO TEST A PATIENT AND A RESULT OF 434 MG/DL HAD BEEN OBTAINED (UNDISCLOSED IF FASTING OR NON-FASTING); THE PATIENT HAD BEEN RETESTED A MINUTE LATER AND THE METER READ HI (VERIFIED IN THE METER MEMORY). THE PATIENT HAD NOT BEEN EXPERIENCING ANY SYMPTOMS AT THE TIME; THE PATIENT HAS A MENTAL ILLNESS, AND THEIR BLOOD GLUCOSE HAD BEEN TESTED AS PER PROCEDURE. DUE TO THE HIGH AND HI RESULTS THE PATIENT HAD BEEN TAKEN TO THE ER ON (B)(6) 2025. THE PATIENT¿S BLOOD GLUCOSE LAB RESULT WHEN AT THE ER HAD BEEN 127 MG/DL (UNDISCLOSED IF FASTING OR NON-FASTING). CALLER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION AS TO WHAT TRANSPIRED AFTER THE RESCUE SQUAD HAD LEFT THE HOSPITAL BUT DID STATE THAT THE PATIENT HAD BEEN TREATED FOR SEPSIS. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/13/2026 AND PER THE CALLER THE OPEN VIAL DATE IS LESS THAN 30 DAYS. THE CALLER STATED HE IS NOT SURE WHICH OF THE 3 TEST STRIP LOT NUMBERS HAD BEEN USED WHEN THE HIGH AND HI RESULTS HAD BEEN OBTAIN

  Patient problems: Sepsis; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 23733177 ↗
• InjuryDec 5, 2025High Test Results; High Test Results

  RESCUE SQUAD REPORTED COMPLAINT FOR HI AND HIGH BLOOD GLUCOSE TEST RESULTS. CALLER ALSO REPORTED COMPLAINT FOR CONTROL TEST RESULT OUT OF CONTROL RANGE. PER THE CALLER, THE TRUE METRIX GO METER HAD BEEN USED TO TEST A PATIENT AND A RESULT OF 434 MG/DL HAD BEEN OBTAINED (UNDISCLOSED IF FASTING OR NON-FASTING); THE PATIENT HAD BEEN RETESTED A MINUTE LATER AND THE METER READ HI (VERIFIED IN THE METER MEMORY). THE PATIENT HAD NOT BEEN EXPERIENCING ANY SYMPTOMS AT THE TIME; THE PATIENT HAS A MENTAL ILLNESS, AND THEIR BLOOD GLUCOSE HAD BEEN TESTED AS PER PROCEDURE. DUE TO THE HIGH AND HI RESULTS THE PATIENT HAD BEEN TAKEN TO THE ER ON (B)(6) 2025. THE PATIENT¿S BLOOD GLUCOSE LAB RESULT WHEN AT THE ER HAD BEEN 127 MG/DL (UNDISCLOSED IF FASTING OR NON-FASTING). CALLER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION AS TO WHAT TRANSPIRED AFTER THE RESCUE SQUAD HAD LEFT THE HOSPITAL BUT DID STATE THAT THE PATIENT HAD BEEN TREATED FOR SEPSIS. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 4/30/2026 AND PER THE CALLER THE OPEN VIAL DATE IS LESS THAN 30 DAYS. THE CALLER STATED HE IS NOT SURE WHICH OF THE 3 TEST STRIP LOT NUMBERS HAD BEEN USED WHEN THE HIGH AND HI RESULTS HAD BEEN OBTAINE

  Patient problems: Sepsis; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 23733087 ↗