TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter (REF RE4019-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00713733069816), received between Dec 29, 2016 and Nov 29, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 115 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 BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 278 AND 318 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/13/2020 AND OPEN VIAL DATE IS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER STATES THAT SHE IS CONCERN WITH THE RESULTS THE METER IS GIVING. CUSTOMER STATES THAT SHE HAS BEEN GETTING HIGH BLOOD RESULT AND A LOT OF ERRORS MESSAGE. CUSTOMER STATES THAT HER NORMAL GLUCOSE RANGE IS 110-115 MG/DL FASTING BUT NOW SHE IS GETTING RESULTS 190'S-250'S FASTING. CUSTOMER IS LEGALLY BLIND AND IS UNABLE TO SEE THE TIME AND DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8116021 ↗
• MalfunctionOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER CONTACT US TO RUN A BLOOD TEST WITH OUR PRODUCT. ON PREVIOUS RAN 01593312 CUSTOMER RAN THE BLOOD TEST AND RECEIVED A RESULT OF 350MG/DL ( UNKNOWN IF FASTING OR NON-FASTING). CUSTOMER THEN STATED THAT WAS EXPERIENCING SYMPTOMS. THE CALL WAS TRANSFERRED TO CCR TO REPORT SYMPTOMS. CUSTOMER WAS NOT CONCERNED WITH THE METER OR THE RESULT. SYMPTOMS WERE NOT SPECIFIED. CUSTOMER SAYS HE MAY BE FEELING ILL BECAUSE OF HEART FAILURE. SAYS CUSTOMER WAS JUST RELEASED FROM THE HOSPITAL REGARDING HEART COMPLICATIONS. CUSTOMER SAYS SHE WILL NOT SEEK MEDICAL ATTENTION.

  Patient problems: No Information

  MAUDE report 7974876 ↗
• MalfunctionOct 13, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULT OF 136 AND 460 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 92 TO 120 MG/DL. THE CUSTOMER 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. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 95 AND 86 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/15/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 136 MG/DL (B)(6) 2017 11:35 AM FASTING: YES, 2:460 MG/DL (B)(6) 2017 09:47 AM FASTING: YES. CUSTOMER CALLED REGARDING RESULTS THAT SHE IS GETTING FROM HER METER. CUSTOMER STATES THAT RESULTS ARE ERRATIC WHEN SHE TOOK A BACK TO BACK BLOOD TEST. CUSTOMER IS FEELING WELL AT THIS TIME AND IS NOT HAVING ANY SYMPTOMS RELATED TO HER DIABETES. HAD CUSTOMER PERFORM A BACK TO BACK BLOOD TEST WITH RESULTS OF 95 AND 86 MG/DL FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6949348 ↗
• MalfunctionJul 20, 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 136 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-100 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 HAD JUST RUN TWO TESTS PRIOR TO CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 124MG/DL (B)(6) 2017 01:36 PM FASTING:YES; 136MG/DL (B)(6) 2017 01:33 PM FASTING:YES; 124MG/DL (B)(6) 2017 02:38 PM FASTING:YES; 118MG/DL (B)(6) 2017 02:30 PM FASTING:YES; 125MG/DL (B)(6) 2017 02:39 PM FASTING:YES. MEMORY CONCERNS: CUSTOMER IS CONCERNED WITH 136MG/DL FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6730085 ↗
• MalfunctionFeb 2, 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 95 TO 110MG/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 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 207 AND 209MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): 205MG/DL (B)(6) 2016 11:35 PM FASTING: YES, 178MG/DL (B)(6) 2016 11:01 PM FASTING: YES, 216MG/DL (B)(6) 2016 12:45 AM FASTING: YES, 204MG/DL (B)(6) 2016 10:06 PM FASTING: YES, 175MG/DL (B)(6) 2016 09:18 AM FASTING: YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6296785 ↗
• MalfunctionDec 29, 2016High 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 169, 162 AND 164MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 87 TO 150MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. 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 163 AND 150MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/22/2017 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: REVIEWED METER MEMORY A 169MG/DL, (B)(6) 2016 08:19 AM, FASTING: YES. A 134MG/DL, (B)(6) 2016 05:47 PM, FASTING: YES. A 162MG/DL, (B)(6) 2016 06:54 PM, FASTING: YES. A 164MG/DL, (B)(6) 2016 06:16 PM, FASTING: YES. A 145MG/DL, (B)(6) 2016 08:14 PM, FASTING: YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6213916 ↗