TRUEtrack TRUEtrack Blood Glucose Monitoring System (REF A4002-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00096295111866), received between Feb 22, 2017 and Jun 19, 2018 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  CONSUMER REPORTED COMPLAINT FOR DEAD METER ACCOMPANIED BY SYMPTOMS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF HAVING A HEADACHE. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/27/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER STATES SHE HAS A HEADACHE AND CAREGIVER STATES THEY WILL NOT SEEK MEDICAL ATTENTION AT THIS TIME. METER IS NOT COMING ON AND CUSTOMER IS TESTING WITH ALTERNATE METER THAT READ HIGH. A NEW BATTERY WAS USED AND WAS IT PROPERLY INSTALLED. THE METER IS STILL UNRESPONSIVE. ADVISED TO SEEK ALTERNATE WAY OF TESTING.

  Patient problems: Headache

  MAUDE report 7616529 ↗
• MalfunctionNov 30, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-140MG/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 BEDROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 166 AND 166MG/DL USING TRUE TRACK. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/21/2019 AND OPEN VIAL DATE IS (B)(6) 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 HI NON-FASTING. CUSTOMER STATES HIS NORMAL FASTING RANGE IS 120-140MG/DL FASTING. CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME OF CALL AND DENIES SIGNS AND SYMPTOMS OF HYPERGLYCEMIA AT THE TIME OF CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7071765 ↗
• MalfunctionAug 22, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 120MG/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 147 AND 145MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/21/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. THE 164MG/DL (B)(6) 2017 01:26 PM FASTING: YES, 134MG/DL (B)(6) 2017 02:27 AM FASTING: YES, 146MG/DL (B)(6) 2017 10:59 AM FASTING: YES, 143MG/DL (B)(6) 2017 10:13 AM FASTING: YES, 149MG/DL (B)(6) 2017 09:45 PM FASTING: YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6810397 ↗
• MalfunctionMay 17, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 454, 410 AND 207 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 113 - 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) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 535 MG/DL USING TRUETRACK METER AND 455 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/21/2018 AND OPEN VIAL DATE IS 04/19/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 454MG/DL (B)(6) 2017 08:00 AM FASTING:YES; 410MG/DL (B)(6) 2017 07:00 PM FASTING:YES 207MG/DL (B)(6) 2017 08:00 AM FASTING:YES; 292MG/DL (B)(6) 2017 08:00 PM FASTING:YES; 223MG/DL (B)(6) 2017 08:00 AM FASTING:YES. MEMORY CONCERNS:CUSTOMERS CAREGIVER IS CONCERNED WITH THE RESULTS OF 454, 410, 207, 292 AND 223 MG/DL FROM THE METERS MEMORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6572389 ↗
• MalfunctionMay 9, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 120 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/22/2019 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS. ATTEMPTED SEVERAL TIMES TO GO INTO METER'S MEMORY, BUT CUSTOMER STATED IT WOULD DISPLAY ONLY THE 30-DAY AVERAGE. UNABLE TO GET THE LAST FIVE READINGS AND THE TIME AND DATE FOR THE LO READING CUSTOMER STATED SHE HAD RECEIVED. CUSTOMER STATED LO READING WAS FROM (B)(6) 2017 IN THE MORNING FASTING. CUSTOMER STATED SHE WAS FEELING WELL AND ASYMPTOMATIC AT TIME OF THE LO READING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6556044 ↗
• MalfunctionApr 3, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 55 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 112 - 135 MG/DL. AT THE TIME OF CALL ON (B)(6) 2017, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED WHEN THE METER READ 55 MG/DL (ON (B)(6) 2017) SHE FELT SHAKY, WEAK AND FELT LIKE SHE WAS GOING TO FAINT. CUSTOMER STATED SHE DID NOT GO TO THE HOSPITAL OR SEEK MEDICAL ATTENTION AT THE TIME THE METER READ 55 MG/DL. CUSTOMER STATED SHE ATE SUGAR AND ATE HAM AND CHEESE ROLLED UP. CUSTOMER STATED AFTER 30 MINUTES SHE FELT BETTER. DURING THE CALL ON (B)(6) 2017, 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 12/16/2018 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMERS STRIPS ARE NOT AFFECTED BY THE VOLUNTARY RECALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:55MG/DL FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455302 ↗
• MalfunctionFeb 22, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. NURSE AT (B)(6) FACILITY IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 406, 519 AND 413 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 126 - 250 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; NURSE STATED SHE IS BUSY AND DOES NOT HAVE TIME TO DO A BACK TO BACK OR CONTROL TEST OVER THE PHONE. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/17/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). NURSE (JOYCE) STATES SHE COMPARED THE RESULTS TO ANOTHER METER THAT SHE USES IN THE FACILITY AND HER RESULTS WERE 100 POINTS HIGHER ON CUSTOMER'S TRUE TRACK METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349238 ↗

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