TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER (REF RE4025-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00093351018992), received between Dec 19, 2016 and Apr 2, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED HE JUST GOT THE TRUEMETRIX METER (B)(6) 2018. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 117, 152, 147 AND 135 MG/DL. CUSTOMER STATED THAT HE HAD PERFORMED A FASTING METER TO METER COMPARISON AND OBTAINED RESULTS OF 152 MG/DL USING TRUEMETRIX METER AND 215 MG/DL USING TRUETRACK METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 225 MG/DL. CUSTOMER WAS USING ALCOHOL AND TESTS FROM THE FOREARM. 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) 2018, BACK TO BACK BLOOD TESTS WERE PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 152 MG/DL AND 128 MG/DL (FOREARM) AND 150 AND 146 MG/DL (FINGER) USING TRUEMETRIX METER. AFTER PERFORMING BACK TO BACK TESTS, CUSTOMER STATED HE WOULD BEGIN TESTING ON HIS FINGERS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7388457 ↗
• MalfunctionJan 2, 2018High 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 317 AND 401 MG/DL. CUSTOMER IS ALSO CONCERNED WITH ERRATIC BLOOD GLUCOSE TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 187 AND 221 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 220 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/17/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET; DATE WAS NOT SET CORRECTLY FOR EARLIER RESULTS): RESULT 1 :194MG/DL DATE: (B)(6) 2017 TIME:09:40PM FASTING. RESULT 3 :187MG/DL DATE: (B)(6) /2017 TIME:12:11PM FASTING. RESULT 4 :221MG/DL DATE: (B)(6) 2017 TIME:12:08PM FASTING. RESULT 2 :317MG/DL DATE: (B)(6) 2017 TIME:09:43PM FASTING. RESULT 2 :401MG/DL DATE: (B)(6) /2017 TIME:10:34PM FASTING. CUSTO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7156771 ↗
• MalfunctionJan 19, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 TO 130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). THE CUSTOMER CALLED WITH CONCERNS REGARDING THEIR METER READING HIGH. THEIR NORMAL FASTING GLUCOSE RANGE IS 110MG/DL TO 130MG/DL. THE CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL. THE CUSTOMER DENIES HAVING ANY SIGNS OR SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA AT THE TIME OF CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6263612 ↗
• MalfunctionDec 19, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 545 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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 ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 141 MG/DL AND 139 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET CORRECTLY): (B)(6). THE CUSTOMER HAS NOT MADE ANY RECENT CHANGES IN THE DIET, EXERCISE . THE CUSTOMER IS TESTING FOUR TIMES A DAY (FASTING).THE CUSTOMER NEEDS THE METER IMMEDIATELY AND WAS AT THE PHARMACY. THE PHARMACIST (AMY) HAS PROVIDED THE CUSTOMER WITH A REPLACEMENT METER AND TEST STRIPS. THE PHARMACY WILL RECEIVE A REPLACEMENT METER KIT, BOX OF TEST STRIPS, AND TWO LEVELS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6185726 ↗