TRUEtrack TRUEtrack Blood Glucose Monitoring System (REF A4007-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00050428318010), received between Dec 14, 2016 and Dec 23, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2016High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 130MG/DL. THE CUSTOMER REPORTED SYMPTOM OF FEELING SWEATY. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 202 AND 177MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/21/2018 AND OPEN VIAL DATE IS APPROXIMATELY ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 191MG/DL (B)(6) 2016 11:58 PM FASTING: YES; 370MG/DL (B)(6) 2016 01:31 PM FASTING: YES; 386MG/DL (B)(6) 2016 12:44 AM FASTING: YES; 271MG/DL (B)(6) 2016 11:53 AM FASTING: YES; 376MG/DL (B)(6) 2016 04:40 PM FASTING: YES. THE DATE FOR THE 191 MG/DL READING IN THE METER'S MEMORY WASN'T SET PROPERLY, AS SHE HAD REMOVED THE BATTERY AND REINSTALLED WITHOUT RESETTING THE DATE. SHE MENTIONED THAT SHE WOULD CONTAC

  Patient problems: Sweating

  MAUDE report 6202260 ↗
• MalfunctionDec 14, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. (B)(6) STAFF, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 549MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 120MG/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 TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 549MG/DL, (B)(6) 2016 05:19 PM. FASTING: NO. UNDISCLOSED. CUSTOMER INFORMED CALLER HE WAS OBTAINING HIGH READINGS FROM METER THAT HE WAS CONCERNED ABOUT AS HE WAS NOT EXPERIENCING ANY SYMPTOMS AT TIME. CUSTOMER RECEIVED THE METER TODAY (B)(6) 2016 FROM (B)(6) PHARMACY AND TESTED WHILE AT PHARMACY, CUSTOMER OBTAINED A READING OF 549MG/DL NON-FASTING (CUSTOMER HAD A CUP OF TEA WITHIN THE LAST 2 HOURS). CUSTOMER IS CONCERNED WITH READINGS AS HE HAS NEVER HAD SUCH HIGH READINGS. ASKED CALLER TO ASK CUSTOMER IF HE WAS EXPERIENCING ANY SYMPTOMS OF HIGH BLOOD SUGAR,CALLER STATES CUSTOMER DENIES HAVING ANY SYMPTOMS BUT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6174245 ↗

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