TRUEtrack TRUEtrack 10 Blood Glucose Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00021292008932), received between Dec 23, 2016 and Jul 19, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2018Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR DEFECTIVE LCD. FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER STATES THE CHARACTERS ARE FADING, AND IT IS HARD TO SEE THE LAST DIGIT. CUSTOMER IS SEEING PARTIAL CHARACTERS. LAST MEDICATION TAKEN WAS WHEN HIS METER MAY HAVE READ 150 MG/DL FASTING WITH NO ADVERSE EFFECT ON THE PATIENT SINCE THE ONLY DIGIT OF THE NUMBERS AFFECTED WAS THE LAST DIGIT. THE METER WAS NOT DROPPED OR MISHANDLED. THE CUSTOMER FEELS WELL AND DID/ DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/13/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7704782 ↗
• MalfunctionMar 8, 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 89-120MG/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 2/28/2020 AND OPEN VIAL DATE IS APPROXIMATELY 2 MONTHS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:125MG/DL 2/12 11:53AM FASTING, RESULT 2:144MG/DL 2/9 9:34AM FASTING, RESULT 3:126MG/DL 2/2 1:00PM NOT SURE, RESULT 4:163MG/DL 2/7 12:49PM FASTING, RESULT 5:178MG/DL 2/6 12:13PM FASTING, CUSTOMER CALLED ABOUT METER GIVING A HIGH BLOOD RESULTS HE IS COMPARING THE RESULTS AND DR IS COMPARING THE RESULTS WHEN THE BLOOD WAS TAKEN AND RAN AT THE LAB OF 103MG/DL FASTING AND HIS METER READ 30 MINUTES LATER WAS 144MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7325282 ↗
• MalfunctionMar 9, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 255 AND 94 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 69 MG/DL AND 81 MG/DL USING TRUETRACK METER. THE CUSTOMER STATED SHE WAS NOT CONCERNED WITH THE RESULTS OF HER BACK TO BACK TEST 69 MG/DL AND 81 MG/DL; SHE HAD JUST EATEN AND DIDN'T FEEL THE MACHINE WAS GIVING HER AN ACCURATE READING. SHE STATED SHE WAS FEELING WELL AND HAD NO SYMPTOMS OF HYPOGLYCEMIA. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 255MG/DL (B)(6)2017 03:06 PM FASTING: YES; 249MG/DL (B)(6) 2017 03:04 PM FASTING: YES; 94MG/DL (B)(6) 2017 02:59 PM FASTING: YES; 104MG/DL (B)(6) 2017 02:58 PM FASTING: YES; 5

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6391393 ↗
• MalfunctionMar 8, 2017Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH CONTROL TEST RESULT FROM RESULTS OBTAINED OF 195 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 111 - 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/15/2019 AND OPEN VIAL DATE IS 01/30/2017. CUSTOMER'S STRIPS ARE NOT AFFECTED BY THE VOLUNTARY RECALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:195MG/DL AND 194MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6387715 ↗
• MalfunctionFeb 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 379, 535 AND 482 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 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 AS THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE CODE CHIP MATCHES THE TEST STRIP. THE CUSTOMER STATED HE HAD NO CHANGES TO HIS EXERCISE ROUTINE, DIET, MEDICATION OR DIABETIC TREATMENT AND THAT HE TAKES INSULIN (34 UNITS). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 379MG/DL DATE: (B)(6) 2017 TIME:12:53PM FASTING , RESULT 2 : 535MG/DL DATE: (B)(6) 2017 TIME: 3:50PM FASTING, RESULT 3 : 482MG/DL DATE: (B)(6) 2017 TIME: 2:43PM FASTING, RESULT 4: 137MG/DL DATE: (B)(6) 2017 TIME: 10:08PM FASTING, RESULT 5 : 565MG/DL DATE: (B)(6) 2017 TIME: 2:32PM FASTING. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6360876 ↗
• MalfunctionFeb 6, 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 148, 251 AND 179 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS RELATED TO HIGH 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 263 MG/DL USING TRUETRACK METER AND 228 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2018 AND OPEN VIAL DATE IS 12/27/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 148MG/DL (B)(6) 2017 06:21 AM FASTING:YES, THE 251MG/DL (B)(6) 2017 09:24 PM FASTING:YES, THE 179MG/DL (B)(6) 2017 05:04 PM FASTING:YES, THE 212MG/DL (B)(6) 2017 07:42 AM FASTING:YES, THE 284MG/DL (B)(6) 2017 12:00 PM FASTING:YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6303950 ↗
• MalfunctionJan 13, 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 420MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 180 TO 200MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 402 AND 354MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/24/2019 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 420MG/DL (B)(6) 2016 02:20:00 PM FASTING: YES CUSTOMER JUST PURCHASED THE METER AND ONLY HAD ONE READING IN THE METER'S MEMORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6249715 ↗
• MalfunctionDec 23, 2016High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 160MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF HI AND HI USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/24/2019 AND OPEN VIAL DATE IS 11/29/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): HI (B)(6) 2016 05:34 PM FASTING: NO, HI (B)(6) 2016 05:34 PM FASTING: NO. CUSTOMER STATES HER METER DID NOT GIVE HER A READING YESTERDAY EITHER BECAUSE IT WAS GIVING HER HI, UNABLE TO GET ANY OTHER READINGS FROM MEMORY AS CUSTOMER STATES ALL SHE SEES IS (B)(6) 2016 HI WITH A TIME OF 05:34 PM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6202141 ↗

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