TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 10 Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00021292007843), received between Jul 5, 2017 and May 7, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 9, 2024Unsealed Device Packaging; Unsealed Device Packaging

  CONSUMER REPORTED COMPLAINT FOR MISSING SAFETY SEAL AND ERROR MESSAGE (E-3). CUSTOMER STATED THAT THE BOX HAD BEEN SEALED WHEN RECEIVED BUT THAT THE TEST STRIP VIAL HAD NOT BEEN SEALED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/20/2026 AND TEST STRIPS HAD BEEN OPENED ON THE DAY OF THE CALL. 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 20881331 ↗
• MalfunctionApr 22, 2022High 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 230, 155, 177 AND 250MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-120MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-150MG/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. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2023 AND OPEN VIAL DATE IS WAS NOT DISCLOSED. 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. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 176MG/DL AND 185MG/DL USING TRUE METRIX METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE NOT SET): RESULT 1: 148 MG/DL DATE:(B)(6) 2020 TIME: 536PM NON-FASTING (TEST TAKEN TODAY), RESULT 2: 230 MG/DL DATE:(B)(6) 2022 TIME: 519PM FASTING PM, RESULT 3: 155 MG/DL DATE:(B)(6) 2022 TIME: 851AM FASTING AM, RESULT 4: 177 MG/DL DATE:(B)(6) 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190540 ↗
• InjuryMar 2, 2022Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-3). WIFE IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING WEAK; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 68 MG/DL USING TRUE METRIX METER. THE CUSTOMER DOES NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE; CUSTOMER STATED THIS IS THE FIRST TIME HE IS PERFORMING A BLOOD TEST. CUSTOMER STATED THAT HE HAS NOT EATEN YET; CUSTOMER STATED HE WILL EAT AND THEN PERFORM ANOTHER BLOOD TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION; LOCATION WAS NOT DISCLOSED BUT CUSTOMER STATED THEY ARE STORED AT ROOM TEMPERATURE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2023 AND OPEN VIAL DATE IS (B)(6) 2022.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 13651929 ↗
• InjuryNov 7, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 50 AND 51MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-150MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF VOMITING AND DIZZINESS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/31/2021 AND OPEN VIAL DATE IS 4 DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: Dizziness; Vomiting

  MAUDE report 9292435 ↗
• MalfunctionAug 24, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. CARETAKER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 285 AND 344 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170 TO 220 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 227 AND 216 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER WAS NOT USING PROPER TECHNIQUE. CUSTOMER WAS EDUCATED IN PROPER BACK TO BACK TESTING. ALL TESTS WERE DONE FASTING. CARETAKER NOT SURE OF LAST A1C. TIME AND DATE ARE CORRECT IN THE METER. CUSTOMER DID CONTROL TEST PRIOR TO CALL. THE RESULT WAS 38 MG/DL. CUSTOMER STATED CONTROL WAS OPENED OVER 3 MONTHS AGO. EDUCATED CUSTOMER OF EXPIRATION DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7814018 ↗
• MalfunctionMar 15, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 223MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-250MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE DINING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). RESULT 1:44MG/DL DATE: (B)(6) 2018 TIME:8:00PM CONTROL. RESULT 2:223MG/DL DATE: (B)(6) 2018 TIME:1:41PM FASTING. RESULT 3:98MG/DL DATE: (B)(6) 2018 TIME:9:13AM FASTING. RESULT 4:120MG/DL DATE: (B)(6) 2018 TIME:5:52PM FASTING. RESULT 5:235MG/DL DATE: (B)(6) 2018 TIME:3:17PM N/FASTING. CUSTOMER SAYS THAT AT HER HUSBAND'S MOST RECENT DOCTOR'S APPOINTMENT, HIS GLUCOSE LEVEL WAS CHECKED USING THE TRUE METRIX METER AND ANOTHER METER. CUSTOMER SAYS THAT ON THE TRUE METRIX, RESUL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7341224 ↗
• MalfunctionJan 16, 2018High 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 169 AND 190 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER WAS NOT FASTING AT TIME. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/17/2019 AND THE OPEN VIAL DATE AT TIME OF CALL IS 40 DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7193971 ↗
• MalfunctionOct 13, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER MEMORY OF 202, 402, 197, 263 AND 175 MG/DL (402 AND 263 ARE NON-FASTING). THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 MG/DL; A NON-FASTING RANGE WAS NOT PROVIDED. THE CUSTOMER IS USING PROPER TESTING TECHNIQUE. 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 157 MG/DL AND 170 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 202 MG/DL DATE: (B)(6) 2017 TIME: 9:21AM FASTING ; RESULT 2 : 402 MG/DL DATE: (B)(6) 2017 TIME: 10:04PM NON- FASTING; RESULT 3 : 197 MG/DL DATE: (B)(6) 2017 TIME: 8:42AM FASTING ; RESULT 4 : 263 MG/DL DATE: (B)(6) 2017 TIME: 8:05PM NON- FASTING; RESULT 5 : 175 MG/DL DATE: (B)(6)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6949905 ↗
• MalfunctionSep 14, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 160, 193 AND 156 MG/DL. THE CUSTOMER ALSO HAD PERFORMED A FASTING BACK TO BACK TEST WITH ANOTHER DEVICE; THE CUSTOMER HAD OBTAINED THE RESULTS OF 160, 193 AND 156 MG/DL USING THE TRUEMETRIX METER AND A RESULT OF 136 MG/DL WAS OBTAINED USING ANOTHER DEVICE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 88 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER WAS FEELING SWEATY AND THAT IT WAS MAYBE FROM HER DIABETES. CUSTOMER DECLINED ANY MEDICAL ATTENTION AT THE TIME OF THE CALL STATING THAT SHE WOULD GET SOMETHING TO EAT. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE CUSTOMER WAS NOT CONCERNED WITH THE FASTING RESULT OF 64 MG/DL IN THE METER MEMORY; CUSTOMER STATED WHEN SHE OBTAINED THIS RESULT SHE DID NOT HAVE ANY SYMPTOMS AND THAT SHE JUST NEEDED TO EAT. THE METER MEMORY WAS REVIEWED FOR PREV

  Patient problems: Sweating

  MAUDE report 6866481 ↗
• MalfunctionJul 5, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. (B)(6), WIFE, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH THE RESULTS OBTAINED OF 253 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 118 TO 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. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 191 AND 200 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALL BACK STATING HIGH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6688221 ↗