TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER (REF RE4011-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00087701426254), received between Mar 2, 2017 and Sep 14, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

1. Oct 7, 2025Class IIOpen, 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 problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2018Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 245 AND 265MG/DL AND FROM BACK TO BACK BLOOD TESTS OF 132 AND 79 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 97 - 145 MG/DL. CUSTOMER IS A NEWLY DIAGNOSED DIABETIC. CUSTOMER WAS NOT ALWAYS USING CORRECT 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) 2018, 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 09/22/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878050 ↗
• MalfunctionJul 3, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 200MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS AT THE TIME OF CALL. 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 BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 284 AND 316MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT SHE HAD BEEN TAKING TOO MUCH INSULIN AND SHE WAS FEELING BAD HAVING DIZZY SPELLS. CUSTOMER WAS NOT EXPERIENCING SYMPTOMS AT THE TIME OF CALL. CUSTOMER DID NOT HAVE TO SEEK ANY MEDICAL ASSISTANCE AS A RESULT OF USING THE METER.

  Patient problems: Dizziness

  MAUDE report 7659653 ↗
• MalfunctionDec 13, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100- 200 MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FATIGUE, INCREASE URINATION, INCREASE THIRST, NEUROPATHY. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (CUSTOMER DECLINED) CUSTOMER STATES HER NORMAL FASTING RANGE IS 380 MG/DL-400 MG/DL FASTING AND PHYSICIAN WOULD LIKE HER GLUCOSE FASTING RANGE TO BE 100 MG/DL -200 MG/DL FASTING. CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL AND CUSTOMER STATES SHE IS HAVING HYPERGLYCEMIC SYMPTOMS OF INCREASE URINATION FATIGUE AND INCREASED THIRST AND NEUROPATHY ADVISED CUSTOMER TO SEEK MEDICAL ATTENTION DUE TO SYMPTOMS OF HYPERGLYCEMIA. CUSTOMER DECLINED TO ANSWER ANY FURTHER QUESTIONS AND DUE TO SYMPTOMS CALL COULD NOT BE CONTINUED. THE CUSTOMER WAS HOSPITALIZED (B)(6) 2017 BUT DECLINED TO ANSWER ANY FURTHER QUESTI

  Patient problems: Neuropathy; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7114211 ↗
• MalfunctionMay 19, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 UPON INSERTION AND SYMPTOMS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF E-3 ACCOMPANIED BY SYMPTOMS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 250 TO 300MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF DRY MOUTH. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. ON (B)(6) 2017, A BLOOD TEST WAS DONE FASTING AND PRODUCED A RESULT OF 218MG/DL USING A TRUE METRIX METER. PRODUCT PROBLEM RESOLVED BY TRAINING DURING THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/27/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Polydipsia

  MAUDE report 6578817 ↗
• MalfunctionMar 2, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 131, 128 AND 118 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 142 MG/DL USING TRUEMETRIX METER AND 129 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS THREE WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN AND STATED THAT HER METER IS GIVING HER HIGH RESULTS FROM WHAT HER OLD METER USE TO GIVE HER. CUSTOMER STATES SHE NEVER RUNS OVER A 100MG/DL AND SHE IS AFRAID OF HER RESULTS BEING THIS HIGH. CUSTOMER STATES SHE HAS NOT SEEN HER DOCTOR IN OVER 6 MONTHS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6371467 ↗