TRUEtrack TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY (REF A4011-85)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00087701405570), received between Mar 28, 2017 and Jun 20, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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.

• MalfunctionJun 20, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 162 AND 245 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 125 MG/DL. CUSTOMER ALSO STATED THAT THE RESULTS FROM THE METER ARE HIGHER COMPARED TO ANOTHER DEVICE; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. AT THE BEGINNING OF THE CALL, THE CUSTOMER STATED HE WAS HAVING BLURRY VISION; BUT HE DID NOT NEED MEDICAL ATTENTION. CUSTOMER STATED THAT HE DRANK ORANGE JUICE, ATE SOMETHING AND FELT BETTER; CUSTOMER STATED HE NO LONGER HAD BLURRY VISION AND WAS ABLE TO CONTINUE TROUBLESHOOTING. CUSTOMER WAS INFORMED TO NO LONGER USING ALCOHOL WIPES AND WILL ADJUST TO WASHING HANDS WITH WARM WATER-SOAP ONLY AND TO THOROUGHLY DRY HANDS. THE CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2021 AND TEST STRIPS WERE OPENED A WEEK AND A HALF AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Blurred Vision

  MAUDE report 8719165 ↗
• MalfunctionSep 25, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 495, 548 AND HI MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 210 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 09/19/2017 AND OPEN VIAL DATE IS 09/02/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: HI, 495, 546,548,463.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6890478 ↗
• MalfunctionAug 21, 2017High 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 105 - 200 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF BLURRY VISION AND DRY MOUTH. CUSTOMER STATED SHE WOULD SEEK MEDICAL ATTENTION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/16/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: HI (B)(6) 2017 2:30PM, 477MG/DL (B)(6) 2017 9:10PM FASTING, 3:551MG/DL (B)(6) 2017 7:51AM FASTING, 4:483MG/DL (B)(6) 2017 6:12PM FASTING, 5:508MG/DL (B)(6) 2017 1:27PM FASTING. MEMORY CONCERNS:HI (B)(6) 2017 6:30PM CUSTOMER CALLED STATING THE METER IS READING HI... CUSTOMER HAS DRY MOUTH AND BLURRY VISION. EXPLAINED TO CUSTOMER THAT AN HI IS AN INDICATION THAT HE BLOOD SUGAR IS OVER 600MG/DL. CUSTOMER WILL SEEK MEDICAL ATTENTION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6806946 ↗
• MalfunctionJun 5, 2017High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 AND HI BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. 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 NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED NON- FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 564MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6)2019 AND OPEN VIAL DATE IS UNDISCLOSED. DAUGHTER CALLED IN AND STATE THAT THE CUSTOMER IS GETTING E-3, AND AFTER SHE PULLED TEST STRIPS OUT OF THE METER, IT READS HI. EXPLAINED TO CUSTOMER THAT AN HI MAY MEANS THAT THE CUSTOMER'S BLOOD SUGAR IS ABOVE 600MG/DL. DAUGHTER STATES THAT HER MOTHER LOOKS FINE, HAS NO SYMPTOMS OF HIGH OR LOW BLOOD SUGAR AND WAS MORE CONCERN WITH THE E-3. I TROUBLESHOOT FOR THE E-3 AND OBTAINED A RESULTS OF 564MG/DL NON- FASTING. LISTED THE POSSIBLE SYMPTOMS OF HIGH BLOOD SUGAR TO

  Patient problems: Hyperglycemia

  MAUDE report 6610735 ↗
• MalfunctionApr 21, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT OF E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE E-3 ERROR MESSAGE OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. CUSTOMER'S WIFE EXPLAINED THEY WERE PLACING THE STRIP IN THE METER, APPLYING THE BLOOD AND THEN PUSHING THE STRIP ALL THE WAY IN. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER REPORTED FEELING WEAK AND TIRED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 486 MG/DL USING TRUETRACK METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/14/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. WIFE CALLING FOR CUSTOMER WHO IS (B)(6) AND WAS HOSPITALIZED LAST WEEK FOR RESPIRATORY PROBLEMS AND DIAGNOSED WITH COPD. ADVISED CUSTOMER'S WIFE TO CALL DOCTOR OR TAKE HUSBAND TO ER BECAUSE HE IS FEELING WEAK AND TIRED AND IT MAY NOT BE RELATED TO HIS HOSPITALIZATION SINCE HIS BGR ON

  Patient problems: Fatigue; Weakness

  MAUDE report 6513355 ↗
• MalfunctionMar 28, 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 122, 151 AND 147MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 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 198 MG/DL AND 149 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/25/2018 AND OPEN VIAL DATE IS (B)(6) 2016 (NO EXACT DATE TO VERIFY IF STRIPS WERE EXPIRED - FOUR MONTHS PAST DATE FIRST OPENED). CUSTOMER STATED THAT SHE HAS NOT HAD ANY CHANGES TO HER EXERCISE AND DIET ROUTINE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): THE 122MG/DL (B)(6) 2017 11:32 AM FASTING:YES, THE 151MG/DL (B)(6) 2017 11:28 AM FASTING:YES, THE 147MG/DL (B)(6) 2017 10:46 AM FASTING:YES, THE 134MG/DL (B)(6) 2017 02:38 PM FASTING:YES, THE 190MG/DL (B)(6) 2017 01:39 AM FAST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6438840 ↗

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