TRUEtrack TRUEtrack Blood Glucose Monitoring System (REF A4031-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00041220842438), received between Jun 22, 2017 and Sep 20, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 200MG/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 NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2020 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(4). THE CUSTOMER DOES NOT KNOW IF HE HAS DIABETES OR NOT DUE TO BEING TOLD DIFFERENT THINGS BY DIFFERENT DOCTORS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7894036 ↗
• MalfunctionApr 23, 2018High 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 223, 369, 174, 416 AND 381 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-150 MG/DL. CUSTOMER STATED THE TRUETRACK METER WAS READING HIGHER THAN HIS OTHER METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. 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 CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450789 ↗
• MalfunctionNov 20, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 71 AND 69 MG/DL FASTING AND 79, 82 AND 84 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 102 MG/DL. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 145 - 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. TEST STRIPS ARE NOT PART OF RECALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH LOW RESULTS. CUSTOMER CHANGED HER EATING HABITS. SHE EATS MORE PROTEIN AND WATER, CUSTOMER ALSO EXERCISE ON AND OFF. CUSTOMER IS CONCERNED WITH ALL RESULTS BEING LOWER THAN EXPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7046612 ↗
• MalfunctionJun 29, 2017Low Test Results; Low Test Results

  CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 125-145MG/DL FASTING. VERIFIED THE STRIPS EXPIRED 10/31/2017. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN PROPERLY STORED AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST AND OBTAINED 94MG/DL AND 96MG/DL FASTING. REVIEWED METER MEMORY THE 95MG/DL (B)(6) 2015 01:49:00 PM FASTING:YES, THE 75MG/DL (B)(6) 2015 01:48:00 PM FASTING:YES, THE 125MG/DL (B)(6) 2015 09:03:00 AM FASTING:YES, THE 157MG/DL (B)(6) 2015 08:30:00 PM FASTING:YES, THE 140MG/DL (B)(6) 2015 07:35:00 AM FASTING:YES, MEMORY CONCERNS:75MG/DL. CUSTOMER READ A BACK TO BACK BLOOD TEST AND THE METER READ 75MG/DL AND 95MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6677251 ↗
• MalfunctionJun 27, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 135MG/DL. THE CUSTOMER FEELS DID REPORT SYMPTOMS OF DRY MOUTH AND HEADACHE. 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 LIVING ROOM. DURING THE CALL ON (B)(6)2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-2 USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/15/2019 AND OPEN VIAL DATE IS (B)(6)2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Headache; Polydipsia

  MAUDE report 6672195 ↗
• MalfunctionJun 22, 2017Incorrect Or Inadequate Test Results; Low Test Results; Incorrect Or Inadequate Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULTS OBTAINED OF 37 AND 212MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170 TO 180MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS 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 BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 45 AND 38MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS 5/23/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): THE 52MG/DL (B)(6) 2017 11:03 AM FASTING: YES, THE 37MG/DL (B)(6) 2017 09:47 AM FASTING: YES, THE 82 MG/DL (B)(6) 2017 09:42 AM FASTING: YES, THE 50MG/DL (B)(6) 2017 09:40 AM FASTING: YES, THE 212MG/DL (B)(6) 2017 09:40 AM FASTING: YES. MEMORY CONCERNS: CUSTOMER CONCERNED WITH READING ON (B)(6) 2017 OF 212MG/DL. THE CUSTOMER CALLED WITH CONCERNS REGARDING THEIR METER READING ERRATIC. THEIR NORMAL FASTING GLUCOSE RANGE IS 170MG/DL

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 6661966 ↗

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