TRUE METRIX TRUE METRIX self monitoring blood glucose meter (REF RE4097-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00725439988933), received between May 1, 2017 and Jun 29, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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. Feb 6, 2026Class IOpen, Classified

   The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

   Z-1545-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 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) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 138 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/23/2019 AND OPEN VIAL DATE IS TWO MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:LO DATE: (B)(6) 2018 TIME:639AM FASTING, RESULT 2:142MG/DL DATE: (B)(6) 2018 TIME:534AM FASTING, RESULT 3:187MG/DL DATE: (B)(6) 2018 TIME:1029AM FASTING, RESULT 4:145MG/DL DATE: (B)(6) 2018 TIME:805AM FASTING, RESULT 5:179MG/DL DATE: (B)(6) 2018 TIME:818AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7650748 ↗
• MalfunctionOct 31, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200-220MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF NAUSEOUS, WEAK AND TIRED. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/22/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 234MG/DL DATE: (B)(6) 2017 TIME: 5:40PM FASTING. RESULT 2: 262 MG/DL DATE: (B)(6) 2017TIME: 5:37PM FASTING. RESULT 3: 290 MG/DL DATE: (B)(6) 2017 TIME: 5:36PM FASTING. RESULT 4: 226 MG/DL DATE: (B)(6) 2017 TIME: 11:52AM FASTING. RESULT 5: 277 MG/DL DATE: (B)(6) 2017TIME: 7:09 AM FASTING. CUSTOMER STATES THAT HIM AND HIS WIFE CHANGED HIS DIET BUT METER KEEPS READING HIGHER THAN EXPECTED. CONCERNED WITH ALL OF THE RESULTS.

  Patient problems: Nausea; Weakness

  MAUDE report 6991768 ↗
• MalfunctionMay 1, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. SON, (B)(6) IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 139,152,161 AND 158MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 O 130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 164 AND 153MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/14/2018 AND OPEN VIAL DATE IS APPROXIMATELY TWO MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): REVIEWED METER MEMORY THE 158MG/DL (B)(6) 2017 06:51:00 AM FASTING: YES, THE 161MG/DL (B)(6) 2017 06:33:00 AM FASTING: YES, THE 206MG/DL (B)(6) 2017 08:52:00 AM FASTING: NO, THE 152MG/DL (B)(6) 2017 07:15:00 AM FASTING: YES, THE 139MG/DL (B)(6) 2017 06:37:00 AM FASTING: YES. MEMORY CONCERNS: UNDISCLOSED. (B)(6) (SON) CALLING STATES THAT THE METER HA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6534605 ↗