TRUEtrack TRUEtrack Blood Glucose Meter FREE METER ONLYRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00096295129489), received between Mar 15, 2017 and Mar 5, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K032657); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. CALLER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY AND SLEEPY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN A PLASTIC BAG OUTSIDE OF THE VIAL. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS UNDISCLOSED AND OPEN VIAL DATE IS UNDISCLOSED. NO TEST STRIP VIAL AVAILABLE. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Lethargy

  MAUDE report 8391009 ↗
• MalfunctionJul 23, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 300 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING COLD AND THIRSTY. NURSE WAS WITH CUSTOMER AND STATED SHE WOULD CALL PHYSICIAN. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018; STRIPS ARE EXPIRED AND NURSE WAS AWARE. CUSTOMER DID NOT REMEMBER THE OPEN VIAL DATE. CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). THE NURSE SAYS SHE IS CALLING BECAUSE SHE SAYS THAT METER IS OLD AND BELIEVES THAT IT IS DEFECTIVE. STRIPS ARE EXPIRED AND NURSE IS AWARE. NO OTHER STRIPS ARE AVAILABLE.

  Patient problems: Polydipsia

  MAUDE report 7710482 ↗
• MalfunctionJun 8, 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 95-190 MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF BLURRY VISION, INCREASE URINATION AND INCREASE THIRST, INCREASED HUNGER. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/19/2019 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6).

  Patient problems: Blurred Vision; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7582787 ↗
• MalfunctionMay 7, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI ACCOMPANIED BY SYMPTOMS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF INCREASED URINATION, EXCESSIVE THIRST, AND LABORED BREATHING. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED USING THE TRUE TRACK METER AND PRODUCED A RESULT OF HI. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/18/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT. CALLER STATES HER MOTHER'S METER READ HI WITH STRIP VIAL RR4531 AND I INFORMED THE CUSTOMER THE STRIPS ARE EXPIRED. CUSTOMER HAD AN ADDITIONAL VIAL RU5215 THAT WAS NOT EXPIRED AND METER READ HI. CUSTOMER HAS INCREASED URINATION, EXCESSIVE THIRST, AND LABORED BREATHING. ADVISED CALLER TO CALL 911 AND TO SEEK MEDICAL ATTENTION FOR THE CUSTOMER.

  Patient problems: Hyperglycemia; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7490779 ↗
• MalfunctionDec 26, 2017Low Test Results; Low Test Results

  CUSTOMER INITIALLY CALLED FOR TRAINING ON HOW TO USE THE TRUETRACK METER. THE CUSTOMER HAS HAD THE METER FOR A WHILE AND JUST BOUGHT A NEW VIAL OF TEST STRIPS AND STARTED TO USE IT AGAIN. 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 LO AND 124 MG/DL USING TRUETRACK METER. THE CUSTOMER IS CONCERNED WITH THE RESULT OBTAINED OF LO. THE CUSTOMER DID NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS 12/04/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :124 MG/DL, DATE: (B)(6) 2017, TIME: 2:51PM, NON- FASTING; RESULT 2 :LOMG/DL, DATE: (B)(6) 2017, TIME: 2:47PM, NON- FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7145579 ↗
• MalfunctionOct 17, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE RESULT. THE CUSTOMER IS CONCERNED WITH THE RESULT OF LO. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 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 IN THE BEDROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 309 AND 379 MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE IS (B)(6) 2017. (B)(6). THE CUSTOMER IS CALLING BECAUSE HE WAS GETTING THE E-3 ERROR MESSAGE; INFORMED THE CUSTOMER ON WHAT E-3 ERROR MEANT. THE CUSTOMER THEN STATED THAT HE WAS ABLE TO OBTAIN A RESULT OF LO; INFORMED THE CUSTOMER ON WHAT LO MEANS THAT THE RESULT IS READING BELOW 20 MG/DL. THE CUSTOMER STATED THAT HE IS NOT EXPERIENCING ANY SYMPTOMS OF LOW AND DOES NOT NEED TO SEEK ANY MEDICAL ATTENTION. THE CUSTOMER HAS EATEN LESS THAN TWO HOURS PRIOR TO PERFORMING THE BACK TO BACK BLOOD TESTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6956296 ↗
• MalfunctionAug 11, 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 RESULT OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 95MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF A DIABETIC COMA. 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 510MG/DL (B)(6) 2017 02:25 PM FASTING: YES, 446MG/DL (B)(6) 2017 01:34 AM FASTING: YES, 258MG/DL (B)(6) 2017 12:00 AM FASTING: YES, 340MG/DL (B)(6) 2017 12:33 AM FASTING: YES, 319MG/DL (B)(6) 2017 02:34 PM FASTING: YES. THE CUSTOMER CALL IN REGARDS TO GETTING HIGH RESULT ON THE METER THAT CAUSED HIM TO GO TO GO TO THE AMBULANCE. THE CUSTOMER STATES ON (B)(6) 2017 HE HAD TAKEN HIS BLOOD SUGAR IN THE EVENING BEFORE BED AND THE RESULTS WAS 340MG/DL. HE TOOK ONLY HALF OF HIS INSULIN AND WENT TO BED. HE HAD A DENTIST APPOINTMENT THE NEXT DAY. THE ALARM KEPT GOING OFF AND HIS WIFE

  Patient problems: Loss of consciousness

  MAUDE report 6787896 ↗
• MalfunctionJul 12, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW RESULTS. CUSTOMER REPORTED NO SYMPTOMS, AND DOES NOT NEED MEDICAL ATTENTION. STRIP EXPIRATION DATE IS 11/30/2017 AND STRIP OPEN DATE IS (B)(6) 2015. STRIP STORAGE IS NOT CORRECT. REVIEWED METER MEMORY: THE 96MG/DL (B)(6) 2015 10:38:00 AM FASTING:YES, THE 103MG/DL (B)(6) 2015 03:22:00 AM FASTING:YES, THE 108MG/DL (B)(6) 2015 01:22:00 AM FASTING:YES, THE 83MG/DL (B)(6) 2015 07:33:00 AM FASTING:YES, THE 92MG/DL (B)(6) 2015 07:08:00 AM FASTING:YES. CUSTOMER TEST STRIPS MATCH THE CODE CHIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6705578 ↗
• MalfunctionMar 15, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CUSTOMER IS CALLING REGARDING "----" ON METER DISPLAY WHEN INSERTING A NEW TEST STRIP. THE CUSTOMER'S EXPECTED FASTING/NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER STATED SHE FELT SHAKY AND DIZZY AND BELIEVED THAT HER GLUCOSE READING WAS LOW BUT THAT SHE CANNOT CHECK DUE TO THE CODE OF "----". CUSTOMER WAS ADVISED TO SEEK MEDICAL ATTENTION; CUSTOMER DECLINED AND STATED SHE WOULD HAVE SOME PROTEIN AND WANTED TO CONTINUE TO TROUBLESHOOT THE METER. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER TOOK OUT THE CODE CHIP AS WELL AS THE BATTERY AND WAITED ABOUT TWO MINUTES BEFORE RE-INSERTING THE BATTERY AND CODE CHIP. WHEN THE CUSTOMER INSERTED A NEW STRIP, THE METER DISPLAYED "----". THE CUSTOMER STATED SHE DID NOT HAVE ANOTHER VIAL OF TEST STRIPS. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/25/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 6408069 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032657. One submission often covers many models, so check the product and lot details in each record.

• Z-2881-2016 · Jun 28, 2016 · Open, Classified
  TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50
• Z-0910-2014 · Oct 2, 2013 · Terminated
  MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 333
• Z-1140-2013 · Feb 25, 2013 · Terminated
  Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole