TRUEtrack TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM (REF A4011-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00087701866807), received between Jan 6, 2017 and Dec 19, 2018 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK-TO-BACK BLOOD TESTS OF 60 AND 422 MG/DL. RESULTS WERE REPORTED BY THE CUSTOMER AND COULD NOT BE CONFIRMED DURING REVIEW OF METER MEMORY RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 - 140 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 BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING AREA. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/15/2020, AND OPEN VIAL DATE IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6) CUSTOMER CALLED ABOUT THE METER READING 60MG/DL THEN 2-5 MINUTES LATER RERAN HER BLOOD IT READ 422MG/DL AS A FASTING, I COULD NOT ACCESS THE RESULTS IN THE MEMORY. CUSTOMER WAS USING ALCOHOL PRIOR TO STICKING HER FINGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8181608 ↗
• MalfunctionDec 18, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS ACCOMPANIED BY SYMPTOMS. PHARMACY TECH IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 300 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FATIGUE AND RAPID HEART BEAT. MEDICAL ATTENTION IS 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 12/31/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CALL TRANSFERRED TO ME HAD TO SPEAK TO THE PHARMACY AT THE HOSPITAL. ON (B)(6) 2018 THE CUSTOMER WAS IN HIS CAR AND RAN HIS BLOOD SINCE HE WAS NOT FEELING WELL. HIS HEART WAS RACING, AND HE WENT INTO THE ER. THEY RAN HIS BLOOD GLUCOSE TEST (DID NOT KNOW HOW MUCH TIME PASSED FROM WHEN HE RAN HIS BLOOD) AND IT WAS 600 MG/DL VS 300 MG/DL. ON HIS METER IN THE CAR. I WAS NOT SPEAKING TO THE CUSTOMER. THE PHARMACY TECH DID NOT HAVE ANY INFORMATION OTHER THAN THE METER WAS NOT READING CORRECTLY VS THE HOSPITAL BLOOD RESULT. THE CUSTOMER MIGHT STILL BE IN

  Patient problems: Fatigue; Tachycardia

  MAUDE report 8174212 ↗
• MalfunctionOct 23, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI AND HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI AND 549, 502, 491 AND 502 MG/DL. DAUGHTER WAS NOT ABLE TO PROVIDE THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. DAUGHTER STATED THE HIGH RESULTS HAVE BEEN HAPPENING FOR ABOUT THREE WEEKS. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF FREQUENT URINATION, DRY MOUTH AND DIZZINESS. DAUGHTER STATED CUSTOMER HAS A MEMORY PROBLEM. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. 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 (LOCATION NOT PROVIDED). THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/21/2020 AND THE OPEN VIAL DATE IS SEVERAL WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). HE HAD GONE TO THE DR LAST WEEK BUT COULD NOT GIVE ANY INFO ON BLOOD THAT WAS DONE. HE IS HAVING A LOT OF PROBLEM SINCE THE MOTHER IS IN A NURSING HOME AND HE IS WORRIED AND GOES TO SEE HER ALL THE TIME BUT SHE SAID SHE CANNOT TAKE CARE OF THE FATHER SINCE

  Patient problems: Dizziness; Urinary Frequency / Polyuria

  MAUDE report 7997151 ↗
• MalfunctionMay 5, 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 182MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 130MG/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 IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 179 AND 161MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 181MG/DL (B)(6) 2017 08:39 AM FASTING: YES, 128MG/DL (B)(6) 2017 06:14 PM FASTING: YES, 182MG/DL (B)(6) 2017 08:21 AM FASTING: YES, 254MG/DL (B)(6) 2017 02:13 PM FASTING: NO. MEMORY CONCERNS: CUSTOMER IS CONCERNED WITH 182MG/DL FASTING RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6549267 ↗
• MalfunctionMar 27, 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 297MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 130MG/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 NOT STORED ACCORDING TO SPECIFICATION IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6437209 ↗
• MalfunctionJan 6, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 315MG/DL. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 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. NO DETAILS OR DATES WERE SPECIFIED BY THE CALLER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/20/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY: I RETURNED CUSTOMER'S CALL BACK IN REGARDS TO HER MOTHER'S METER. CUSTOMER ANSWERED THE PHONE AND WAS VERY IRATE AND UPSET AT THE TIME OF THE CALL. I APOLOGIZED TO CUSTOMER AND EXPLAINED THAT I'D LOVE TO HELP ASSIST WITH HER MOTHER'S METER. CUSTOMER THEN EXPLAINED THAT I SHOULDN'T BE CALLING BACK ON A SUNDAY BECAUSE THAT IS A CHURCH DAY. CUSTOMER STATED THAT HER MOTHER'S METER WAS READING HIGH. CUSTOMER DID NOT WANT TO DISCLOSE HER NAME. CUSTOMER ALSO DID NOT LET ME TALK OR ASK QUESTIONS. CUSTOMER READ ME LOT RS4806 AND PROCEEDED TO TELL ME THAT HER MOTHER OBTAINED A READI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6229089 ↗

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