TRUEtrack TRUEtrack Blood Glucose Meter - Free Meter Only (REF A4088-85)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00021292009281), received between Aug 21, 2017 and Apr 10, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM FASTING BACK TO BACK BLOOD TESTS PERFORMED DURING THE CALL OF 58 AND 88 MG/DL USING TRUETRACK METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 100 MG/DL. AT THE TIME OF THE CALL ON (B)(6) 2018, THE CUSTOMER REPORTED SYMPTOMS OF HEADACHE, DIZZY AND SWEATY; MEDICAL ATTENTION WAS NOT NEEDED AT TIME OF CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/21/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET; UNABLE TO VERIFY MORE THAN TWO MEMORY RESULTS): RESULT 1 :69 MG/DL DATE: (B)(6) 2018 TIME: 11:55 AM FASTING. RESULT 2 :88 MG/DL DATE: (B)(6) 2018 TIME: 02:25 PM FASTING. CUSTOMER CALLED STATING HER BLOOD SUGAR IS READING LOWER THAN NORMAL ON THIS METER. CUSTOMERS REGULAR FASTING RANGE IS 80-100 MG/DL. CUSTOMER STATES HER METER READ 69 MG/DL FASTING. CUSTOMER IS FEELING SYMPTOMS OF LOW BLOOD SUGAR. UNABLE TO VERIFY MORE THAN 2 RESULTS ON THE METERS MEMORY. WHILE DOING THE BACK TO BACK TEST, THE

  Patient problems: Dizziness; Headache; Shaking/Tremors

  MAUDE report 7412436 ↗
• MalfunctionAug 24, 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 302, 416, 312 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 110 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; CUSTOMER STATED SHE DOES NOT HAVE ANY STRIPS LEFT. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. 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: A 302MG/DL (B)(6)/2017 10:17 AM FASTING:YES. A 416MG/DL (B)(6)2017 02:53 PM FASTING:YES. A 312MG/DL (B)(6)2017 01:42 PM FASTING:YES. A 348MG/DL (B)(6)2017 11:13 AM FASTING:YES. A 214MG/DL (B)(6)2017 12:11 PM FASTING:YES. MEMORY CONCERNS:CUSTOMER IS CONCERNED WITH THE RESULTS OF 302, 416, 312, 348 AND 214 MG/DL IN THE METERS MEMORY. CUSTOMER STORES STRIPS IN BEDROOM HOWEVER CUSTOMER ADVISED CCR THAT SHE DOES NOT HAVE ANY STRIPS LEFT AND SHE CANNOT AFFORD TO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816353 ↗
• MalfunctionAug 21, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL TESTS RESULTS FROM THE METER MEMORY. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 135 - 175 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 140 MG/DL AND 159 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/28/2018 AND OPEN VIAL DATE AT TIME OF CALL IS TWO MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 77MG/DL, (B)(6) 2017, 09:39 PM, FASTING: YES; 73MG/DL, (B)(6) 2017, 09:30 PM, FASTING: YES; 30MG/DL, (B)(6) 2017, 09:12 PM, FASTING: YES; 81MG/DL, (B)(6) 2017, 10:30 AM, FASTING: YES; 68MG/DL, (B)(6) 2017, 10:24 AM, FASTING: YES. MEMORY CONCERNS: CUSTOMER IS CONCERN WITH ALL THESE RESULTS. (B)(6) (SISTER) CALLING STATES THAT THE METER IS NOT GIVING CORRECT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6807009 ↗

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