TRUEtrack TRUEtrack BLOOD GLUCOSE METER (REF A4027-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00021292001261), received between Feb 6, 2017 and Oct 10, 2018 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 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 170 TO 180MG/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 07/18/2020 AND OPEN VIAL DATE IS LAST MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): RESULT 1:210MG/DL DATE: (B)(6) 2018 TIME:9:44AM FASTING; RESULT 2:280MG/DL DATE: (B)(6) 2018 TIME:9:45AM FASTING; RESULT 3:408MG/DL DATE: (B)(6) 2018 TIME:12:01PM FASTING; RESULT 4:225MG/DL DATE: (B)(6) 2018 TIME:8:56AM FASTING; RESULT 5:199MG/DL DATE: (B)(6) 2018 TIME:2:44PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7954072 ↗
• MalfunctionJun 29, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI. THE CUSTOMER IS CONCERNED WITH THE RESULTS OBTAINED OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 150MG/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 BY CUSTOMER ACCORDING TO SPECIFICATION. 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 326 AND 388MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/13/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): THE 381MG/DL (B)(6) 2017 11:14 AM FASTING: YES, THE 444MG/DL (B)(6) 2017 12:05 PM FASTING: YES, THE 552MG/DL (B)(6) 2017 09:59 PM FASTING: YES, HI (B)(6) 2017 01:31 AM FASTING: YES, HI (B)(6) 2017 08:31 AM FASTING: YES. CUSTOMER IS CONCERNED WITH THE HIGH READINGS SHE HAS OBTAINED RECENTLY AS SHE HAS NOT HAD ANY CHANGES IN HER DAILY ROUTINE. CUSTOMER IS ALSO CONCERNED WITH THE HI READING FASTING ON (B)(6) 2017 AT 8:31 AM. CUSTOMER STATES TIME WAS NOT SET ON METER, BUT TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6677200 ↗
• MalfunctionFeb 6, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON OF TEST RESULTED REPORTED USING TRUETRACK METER OF 66 MG/DL AND THE TEST RESULT REPORTED USING ANOTHER DEVICE OF 108 MG/DL. ALSO, THE CUSTOMER STATED THE READING OBTAINED ON (B)(6) 2017 AT 10:13 PM OF 125 MG/DL FASTING WAS LOWER COMPARED TO HER OTHER METER WHICH TESTED 166 MG/DL. THE CUSTOMER STATED SHE KNOWS THE READING SHOULD HAVE BEEN HIGHER THAN 125 MG/DL AS SHE HAD SOMETHING THAT SHOULD HAVE RAISED HER BLOOD SUGAR HIGHER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 93 - 108 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS RELATED TO LOW BLOOD GLUCOSE. 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 AS CUSTOMER STATED SHE HAS SOME STRIPS STORED IN THE METER'S CASE AND NOT IN THE ORIGINAL CONTAINER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/15/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE CUSTOMER STATED SHE CURRENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6305076 ↗

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