TRUEtrack TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM (REF A4088-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00021292004576), received between Apr 21, 2017 and Mar 20, 2018 — classified as 4 malfunctions.

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

• MalfunctionMar 20, 2018High Test Results; High Test Results

  CONSUMER CALLED TO ASK WHAT HI BLOOD GLUCOSE RESULTS MEANS. CUSTOMER WAS TRYING TO GET THE METER TO READ BUT SHE IS GETTING ONLY HI, TOLD HER THAT THE METER WILL READ UP TO 600 MG/DL AND THEN READ HI IF IT IS OVER THAT. SHE THEN DID THE BLOOD ON HER YOUNG SON NOT DIABETIC AND IT WAS 82 MG/DL SO SHE KNOWS THE METER IS WORKING. SHE ATE ABOUT 2-3 HRS ABOUT AND STILL READING HI. SHE HAS NOT BEEN PUT ON INSULIN YET ONLY ON METFORMIN AND SHE SAID THEY WERE TALKING ABOUT PUTTING HER ON INSULIN BUT HAS NOT AS OF YET. SHE WILL TAKE HER METFORMIN AGAIN AS PRESCRIBED AND THEN EAT. WE TOLD HER IF SHE STILL GETS A HI AGAIN TO CALL 911 OR GO BACK TO HOSPITAL OR CALL HER DR ON CALL. SHE TOLD US AGAIN SHE IS FEELING FINE. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS DECLINED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 7/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER ALSO STATES THAT O

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7352409 ↗
• MalfunctionDec 21, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED ABOVE 200MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140MG/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 DINING ROOM. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 195MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/21/2019 AND OPEN VIAL DATE IS 11/30/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING HIGH. CUSTOMER STATES THE METER READ 300MG/DL. CUSTOMER STATES HIS NORMAL FASTING RANGE IS 140MG/DL FASTING. HIS LAST A1C WAS 3 OR 4 MONTH WAS 8.1% CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL AND DENIES SIGNS AND SYMPTOMS OF HYPERGLYCEMIA AT THE TIME OF CALL. CUSTOMER WAS ADVISED HIM OF THE A1C (186MG/DL) AND HE SAID THAT HE BLOOD SUGAR HAS NEVER BEEN HIGHER THAN 140MG/DL UP UNTIL RECENTLY. CUSTOMER STATES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7138734 ↗
• MalfunctionJun 26, 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 178, 192 AND 210 MG/DL. CUSTOMER STATED SHE WAS ALSO COMPARING THE METER TO ANOTHER COMPANY'S METER (METER TO METER COMPARISON RESULTS WERE NOT PROVIDED). THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 88 - 129 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE IS MAY 2017. CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT. CODE CHIP MATCHES THE TEST STRIPS. DURING THE CALL ON (B)(6)2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 123 MG/DL AND 126 MG/DL USING TRUETRACK METER; CUSTOMER WAS SATISFIED WITH BACK TO BACK RESULTS. CUSTOMER HAD OPENED A NEW VIAL OF TEST STRIPS FOR THE BACK TO BACK TEST - LOT RT5029. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET; CUSTOMER STATED SHE TAKES HER BLOOD TESTS BETWEEN 8 AND 9 AM.): 1:178MG/DL (B

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6667737 ↗
• MalfunctionApr 21, 2017Battery Problem; Battery Problem

  THE CUSTOMER CALLED STATING THE METER WOULD NOT TURN ON. THE CUSTOMER ALSO STATED THAT IT LOOKS LIKE THE BATTERY EXPLODED IN THE METER. CUSTOMER STATED SHE HAS NOT USED THE METER FOR A YEAR AND A HALF. DURING THE CALL ON (B)(6) 2017, IT WAS VERIFIED THAT THE BATTERY HAD BEEN INSTALLED PROPERLY WITH THE + SIGN UPWARDS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER STATED SHE WAS HAVING TINGLING IN HER HANDS AND FEET. CUSTOMER STATED SHE THOUGHT HER BLOOD GLUCOSE WAS HIGH. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2016; STRIPS ARE EXPIRED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Tingling

  MAUDE report 6512948 ↗

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