TRUEtrack TRUEtrack blood glucose monitoring system (REF A4089-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00052569132463), received between Nov 29, 2016 and Nov 30, 2018 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 276, 275, 200, 320 AND 343 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 165 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. THE CUSTOMER WAS NOT AVAILABLE TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/13/2020 AND OPEN VIAL DATE IS 4 - 5 DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:276MG/DL DATE: (B)(6) 2018 TIME:3:35PM FASTING; RESULT 2:275MG/DL DATE: (B)(6) 2018 TIME:10:28AM FASTING; RESULT 3:200MG/DL DATE: (B)(6) 2018 TIME:3:45PM FASTING; RESULT 4:320MG/DL DATE:(B)(6) 2018 TIME:9:25AM FASTING; RESULT 5:343MG/DL DATE:(B)(6) 2018 TIME:8:03PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8120140 ↗
• MalfunctionOct 19, 2018High Test Results; Adverse Event Without Identified Device or Use Problem; High Test Results; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR HI ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-180MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF FEELING VERY TIRED. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). RESULT 1:560MG/DL DATE:9/24/2018 TIME:12:18PM N/FASTING. RESULT 2:HI, DATE: (B)(6) 2018, TIME:10:46AM, N/FASTING. RESULT 3:HI, DATE: (B)(6) 2018, TIME:9:41AM, FASTING. RESULT 4:HI, DATE: (B)(6) 2018, TIME:8:08AM, FASTING. RESULT 5:HI, DATE: (B)(6) 2018, TIME:10:57PM, N/FASTING. A CALL BACK WAS MADE ON 9/27/2018; CUSTOMERS CONDITION HAS NOT IMPROVED SINCE THE TIME OF THE CALL. CUSTOMER DID NOT TAKE HER LANTUS LAST NIGHT AND WOKE UP WITH A 452MG/DL FASTING AS HER BLOOD SUGAR AND WAS NOT FEELING WELL. CUSTOMER IS STILL FEELING EXHAUSTED AND VERY WEAK. CUSTOMER DID NEED TO SEEK ANY MEDICAL INTERVENTION ON (B)(6) 2018. CUSTOMER HAS B

  Patient problems: Fatigue; Hyperglycemia; Weakness

  MAUDE report 7987268 ↗
• MalfunctionFeb 7, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-8 PAST ADVERSE EVENT ACCOMPANIED BY SYMPTOMS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AT TIME OF CALL BUT DID REPORT SYMPTOMS OF COLLAPSING PRIOR TO TODAY'S DATE. MEDICAL ATTENTION IS REPORTED AS A RESULT OF REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 95 MG/DL NON-FASTING USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CAREGIVER EXPLAINS WHEN SHE CAME TO SEE HIM, SHE FOUND HIM COLLAPSED ON THE GROUND AND CALLED 9-1-1. PER CAREGIVER, CUSTOMER WAS HYPOGLYCEMIC AND COLLAPSED ON THE GROUND. CUSTOMER WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH HYPOGLYCEMIA. CAREGIVER REFUSED TO PROVIDE INFORMATION SUCH AS, TIME AND DATE OF INCIDENT, LAB RESULTS AND GLUCOSE METER BEING USED AT THE TIME. CUSTOMER IS FEELING FINE AT THE TIME OF CALL. NO OTHER MEDICAL ATTENTIONS REPORTED AT THE TIME O

  Patient problems: Fainting; Hypoglycemia

  MAUDE report 7247283 ↗
• MalfunctionOct 20, 2017High 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 80 TO 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. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 152 AND 183MG/DL USING METER TYPE METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/13/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6966131 ↗
• MalfunctionJul 10, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW RESULTS. CUSTOMER REPORTED NO SYMPTOMS, AND DOES NOT NEED MEDICAL ATTENTION. STRIP STORAGE IS IN THE KITCHEN. CUSTOMER'S METER IS GIVING ABOUT 60 POINTS LOWER. CUSTOMER STATES THAT HE COMPARES THE METER TO TWO DIFFERENT DR. OFFICE METERS. CUSTOMER STATES THAT HIS LAST A1C WAS 7.8-8.2. HE IS GETTING AN AVERAGE OF 140MG/DL ON THE METER. CUSTOMER IS LEGALLY BLIND AND IS UNABLE TO SEE THE SERIAL # AND THE STRIPS LOT #. CUSTOMER STATES THAT HE IS NOT SURE WHAT HIS EXPECTED RANGE IS VARIES. BUT HIS A1C TEST IS SHOWING IN THE 200MG/DL RANGE. CUSTOMER IS TAKING INVOCANA. CUSTOMER STATES THAT HE WAS TESTING ONCE A DAY, BUT HE HAS NOT USED THE METER FOR ABOUT A MONTH NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6696582 ↗
• MalfunctionJul 6, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR READING OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS :120-126MG/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 STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/30/2017 (EXPIRED) AND OPEN VIAL DATE IS (B)(6) 2016 (MORE THAN 4 MONTHS). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY(DATE/TIME NOT SET): HI (B)(6) 2017 12:01 PM FASTING: NO; 273MG/DL (B)(6) 2017 08:25 PM FASTING: YES; 290MG/DL (B)(6) 2017 08:12 PM FASTING: YES; 454MG/DL (B)(6) 2017 10:19 PM FASTING: YES; 206MG/DL (B)(6) 2017 09:30 PM FASTING: YES. MEMORY CONCERNS: CUSTOMER CONCERNED WITH RESULTS (B)(6) 2017 OF HI. THE NORMAL FASTING GLUCOSE RANGE IS 120MG/DL TO 126MG/DL OVER A YEAR AGO WHEN HE WAS CHECKING REGULARLY. THE CUSTOMER IS USING EXPIRED TEST STRIPS AND HE HAS BEEN USING THE SAME VIAL FOR A YEAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6690922 ↗
• MalfunctionApr 5, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 130 AND 187MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 150MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF BLURRY VISION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 134 AND 184MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/26/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER REPORTED COMPLAINT FOR ERRATIC RESULTS. CUSTOMER STATES HE HAS BLURRY VISION BUT DOES NOT REQUIRE MEDICAL ATTENTION DUE TO RESULTS OBTAINED. IN (B)(6) 2017, CUSTOMER SUFFERED AN EPISODE OF SYNCOPE AND HAD TO BE TAKEN TO THE HOSPITAL WITH A BGR: 25 MG/DL WHEN PARAMEDICS ARRIVED. CUSTOMER'S METER READ BETWEEN 170-180 MG/DL. CUSTOMER'S ORDERS ARE TO ADMINISTER 1 U OF FAST-ACTING INSULIN FOR EVERY 10 MG/DL OVE

  Patient problems: Blurred Vision; Fainting; Hypoglycemia

  MAUDE report 6461726 ↗
• MalfunctionJan 18, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 270, 408 AND 321 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160 - 180 MG/DL. AT THE TIME OF THE CALL ON (B)(6) 2016, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. WIFE STATED THAT THE CUSTOMER WENT TO EMERGENCY DEPARTMENT ON (B)(6) 2016 AFTER GETTING A 518 MG/DL READING (FASTING) ON HIS METER. CUSTOMER DIDN'T HAVE ANY SYMPTOMS AT THAT TIME. WIFE STATED AT THE HOSPITAL THEY CHECKED HIS BLOOD GLUCOSE WITH THEIR METER AND IT WAS 200 POINTS LOWER AND THAT HE WAS RELEASED THAT SAME DAY. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN CUPBOARD. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/25/2016 AND OPEN VIAL DATE IS (B)(6) 2016. WIFE STATED SHE HAD PURCHASED THE STRIPS FROM A PHARMACY AT THE BEGINNING OF DECEMBER. WIFE STATED THAT SHE HAD PROBLEMS WITH OTHER METERS AND PRODUCTS THAT SHE HAD PURCHASED FROM THAT PARTICULAR PHARMACY. THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6260871 ↗
• MalfunctionNov 29, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 393 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET CORRECTLY): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6132918 ↗

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