TRUEtrack TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM (REF A4H01-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00021292001018), received between Nov 22, 2016 and Sep 17, 2021 — classified as 81 malfunctions.

The most frequently reported specific device problem is “High Test Results” (49 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 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2021Failure to Power Up; No Apparent Adverse Event; Failure to Power Up; No Apparent Adverse Event

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE BATTERY IN THE TRUE TRACK METER HAD BEEN CHANGED (B)(6) 2020. THE CUSTOMER IS USING THE CORRECT BATTERY FOR THE METER IN THE CORRECT ORIENTATION. DURING THE CALL, THE TRUE TRACK METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED. THE TEST STRIPS ARE EXPIRED - MANUFACTURER'S EXPIRATION DATE IS 02/28/2017 AND TEST STRIPS ARE PART OF RECALL. DAUGHTER STATED THAT CUSTOMER WILL PURCHASE NEW TEST STRIPS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12487806 ↗
• MalfunctionMar 23, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED THE HIGH BLOOD GLUCOSE RESULTS STARTED TWO WEEKS AGO. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 151, 170 AND 143 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 105 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/31/2022 AND OPEN VIAL DATE IS 01/2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9867947 ↗
• MalfunctionOct 24, 2019Incomplete or Missing Packaging; Incomplete or Missing Packaging

  CONSUMER REPORTED COMPLAINT FOR MISSING PACKAGE ITEM (CODE CHIP). THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/26/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235618 ↗
• MalfunctionDec 27, 2018High 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 323 AND 219 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 150 MG/DL. CUSTOMER WAS COMPARING RESULTS TO ANOTHER DEVICE AND STATED THE RESULTS OBTAINED USING THE TRUETRACK METER WERE HIGHER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. 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 DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/30/2021 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :147MG/DL DATE: (B)(6) 2018 TIME:05:58AM FASTING; RESULT 2 :323MG/DL DATE: (B)(6) 2018 TIME:10:54PM FASTING; RESULT 3 :219MG/DL DATE: (B)(6) 2018 TIME:02:33PM FASTING; RESULT 4 :173MG/DL DATE: (B)(6) 2018 TIME:12:01PM FASTING; RESULT 5 :172MG/DL DATE: (B)(6) 2018 TIME:06:12AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199291 ↗
• MalfunctionDec 20, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 305 AND 319 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 175 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) 2018, A BACK-TO-BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 240 MG/DL AND 243 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/15/2020, AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6) CUSTOMER STATES THE METER IS READING HIGH BLOOD RESULTS AND ONLY CONCERNED WITH THIS. CUSTOMER STATES THEIR NORMAL FASTING RANGE IS 150MG/DL-175MG/DL FASTING. CUSTOMER ADJUSTED METER'S POSITION FROM HORIZONTAL POSITION WHILE TESTING TO A VERTICAL POSITION. CUSTOMER STATES THEY ADJUSTED THEIR TESTING TECHNIQUE BY RUBBING HANDS BELOW WAIST LEVEL PRIOR TO PRICKING FINGER. CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION AT THE TIME O

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8184731 ↗
• MalfunctionOct 26, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 228, 353 AND 279 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160 - 200 MG/DL. CUSTOMER WAS NOT USING CORRECT TESTING TECHNIQUE FOR THE BACK TO BACK TESTS. 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) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2020 AND OPEN VIAL DATE IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET; RESULTS OF 388 AND 298 MG/DL ARE NOT CUSTOMER'S RESULTS, THEY ARE HER HUSBAND'S RESULTS): RESULT 1:228MG/DL (B)(6) 8:09AM FASTING; RESULT 2:353MG.DL (B)(6) 8:05AM FASTING; RESULT 3:279MG/DL (B)(6) 8:04AM FASTING; RESULT 4:388MG/DL NOT CUSTOMER'S RESULT, THIS IS HER HUSBAND'S RESULT; RESULT 5:298MG/DL NOT CUSTOMER'S RESULT, THIS IS HER HUSBAND'S RESULT; RESULT 6:182MG/DL (B)(6) 6:52AM FASTING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8009299 ↗
• MalfunctionOct 11, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 200MG/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 08/31/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7958151 ↗
• MalfunctionOct 10, 2018High 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 214, 216, 275, 286 AND 263 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 - 140 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) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 215 MG/DL AND 205 MG/DL USING THE TRUETRACK METER. CUSTOMER STATED THE PRODUCT IS STORED IN HER BEDROOM AND THAT SHE HAS NO A/C IN HER HOME AND USES A FAN AND OPENS THE WINDOW IN HER ROOM FOR COOLING. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/21/2020 AND OPEN VIAL DATE IS THREE WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET AS CUSTOMER STATED SHE CHANGED THE BATTERY): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7952956 ↗
• MalfunctionSep 24, 2018High 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 212, 219, 181, 238 AND 240 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 180 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING ILL AND HAD SYMPTOMS OF FATIGUE AND BLURRED VISION. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/26/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Blurred Vision; Fatigue

  MAUDE report 7903767 ↗
• MalfunctionSep 24, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER HAD CALLED TO PERFORM BLOOD TEST, REFERENCE INTERNAL REPORT # (B)(4), AND HAD OBTAINED A RESULT OF 72 MG/DL AND BELIEVED IT TO BE LOW. CUSTOMER DID NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING TIRED AND STATED THAT HE HAS BEEN GOING TO BED EARLY. CUSTOMER WAS GOING TO CALL HIS DOCTOR. THE PRODUCT STORAGE WAS NOT DISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. TEST STRIPS ARE NOT IMPACTED BY RECALL. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue; Weakness

  MAUDE report 7903284 ↗
• MalfunctionSep 10, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 191 AND 204MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING NAUSEOUS. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. CUSTOMER STATED THE PRODUCT IS STORED IN HER PURSE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/13/2019 AND OPEN VIAL DATE IS (B)(6) 2018. METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Nausea

  MAUDE report 7859958 ↗
• MalfunctionAug 23, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 392 AND 254 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 180 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 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 07/31/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1 :195MG/DL DATE: (B)(6) 2018 TIME:12:40PM NOT FASTING; RESULT 2 :192MG/DL DATE: (B)(6) 2018 TIME:12:40PM NOT FASTING; RESULT 3 :181MG/DL DATE: (B)(6) 2018 TIME:12:48PM NOT FASTING; RESULT 4 :392MG/DL DATE: (B)(6) 2018 TIME:12:40PM FASTING; RESULT 5 :254MG/DL DATE: (B)(6) 2018 TIME:07:15PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810147 ↗
• MalfunctionAug 13, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 406 AND 516 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. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 513 MG/DL AND 518 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2020 AND OPEN VIAL DATE IS JULY 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7777228 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO STATED SHE RECEIVED E-5 ERROR CODE. AT THE TIME OF THE CALL ON (B)(6) 2018, THE CUSTOMER REPORTED SYMPTOMS OF DRY MOUTH, INCREASED URINATION AND BLURRY VISION. CUSTOMER STATED SHE WOULD SEEK MEDICAL INTERVENTION AND WOULD GO TO THE HOSPITAL. NO FURTHER INFORMATION WAS ABLE TO OBTAINED. AT FOLLOW-UP CALL ON (B)(6) 2018, THE CUSTOMER'S CONDITION HAD IMPROVED AND SHE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. CUSTOMER STATED THAT AFTER THE INITIAL CALL ON (B)(6) 2018, DUE TO THE HI AND SYMPTOMS, SHE HAD DRIVEN TO THE ER. THE CUSTOMER'S LAB TEST BLOOD GLUCOSE RESULT WHEN AT THE HOSPITAL WAS 699 MG/DL. THE DIAGNOSIS WAS HIGH BLOOD SUGAR AND CUSTOMER WAS GIVEN IV AND INSULIN. THE CUSTOMER LEFT THE HOSPITAL ON (B)(6) 2018. NO NEW MEDICATIONS OR HEALTHCARE PROGRAM WAS SUGGESTED. ADDITIONAL BLOOD TESTS WERE PERFORMED BY THE CUSTOMER USING THE TRUETRACK METER. INFORMATION THAT WAS UNABLE TO BE OBTAINED DURING INITIAL CALL WAS OBTAINED DURING FOLLOW-UP CALL ON (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY AND CUSTOMER WAS CONCERNED WITH TEST RESULT OF HI OBTAINED (B)(6) 2018. THE CUST

  Patient problems: Blurred Vision; Hyperglycemia; Urinary Frequency / Polyuria

  MAUDE report 7690321 ↗
• MalfunctionJun 19, 2018High 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 273 MG/DL NON-FASTING AND 187 MG/DL FASTING. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 160 MG/DL AND FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 111 - 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) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 262 MG/DL AND 224 MG/DL USING TRUETRACK METER. CUSTOMER WAS ALSO CONCERNED WITH THESE RESULTS BEING HIGH. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7617022 ↗
• MalfunctionJun 12, 2018Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER COMPLAINT OF DEFECTIVE LCD. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. STORAGE OF PRODUCT LOCATION IS UNDISCLOSED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/13/2019 AND OPEN VIAL DATE IS UNDISCLOSED. CUSTOMER STATES THAT THE MIDDLE DIGIT IS ILLEGIBLE, IT IS NOT CLEAR AND CANNOT READ IT. CALLER STATES THE FIRST AND THIRD DIGIT ARE LEGIBLE. NO MEDICATION WAS ADMINISTERED DUE TO THE GLUCOSE READING. NO ADVERSE EVENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7591215 ↗
• MalfunctionMay 23, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND HI DISPLAY. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 427MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 -170MG/DL AND 180 -200MG/DL NOT FASTING. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE DINING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/17/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). THE CUSTOMER IS STATING THAT WHEN HE COMPARES THE RESULTS FROM HIS METER TO HIS OTHER METER (UNKNOWN MANUFACTURE AND TRUE TRACK METER) IT IS READING HIGHER. INFORMED THE CUSTOMER ABOUT COMPARING METERS AGAINST METERS BUT AGAINST THE LABORATORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7538836 ↗
• MalfunctionMay 16, 2018Incorrect 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 BACK TO BACK BLOOD TESTS OF 61 AND 239 MG/DL. CUSTOMER WAS ONLY CONCERNED RESULTS WERE ERRATIC. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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) 2018, 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/20/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519426 ↗
• MalfunctionApr 24, 2018High Test Results; High Test Results

  CONSUMER INITIALLY CALLED REGARDING CODE ----. DURING TROUBLESHOOTING, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF HI AND HI USING TRUETRACK METER. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE RUNS OVER 600 MG/DL ALL THE TIME (FASTING AND NON-FASTING). AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF INCREASED URINATION AND DRY MOUTH. CUSTOMER STATED HE WAS GOING TO SEEK MEDICAL INTERVENTION. CUSTOMER JUST RECEIVED THE TEST STRIPS ON (B)(6) 2018. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE TRUETRACK METER IS NEW AND THERE ARE NO RESULTS IN THE METER MEMORY. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. NO RESULTS ON THE MEMORY BECAUSE IT'S A NEW METER.

  Patient problems: Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7454710 ↗
• MalfunctionApr 16, 2018High 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 483 AND 373 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170 - 180 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) 2018, 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/16/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7433369 ↗
• MalfunctionMar 2, 2018High 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 328 AND 250 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 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) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 225 MG/DL AND 249 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 AND OPEN VIAL DATE IS 02/03/2018. THE CODE CHIP DOES NOT MATCH THE TEST STRIP LOT NUMBER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311151 ↗
• MalfunctionFeb 13, 2018High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 423 AND 559 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75 TO 110 MG/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 STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/13/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): (B)(6). WHEN ATTEMPTING TO DO THE BACK TO BACK TESTING THE METER READ CODE (---) AND CUSTOMER COULD NOT TEST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7267764 ↗
• MalfunctionFeb 1, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING WEAK, TIRED AND BLURRY VISION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. CUSTOMER LEFT THE VIAL OF TEST STRIPS OPEN SINCE THE MORNING. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-3 USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/27/2020 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Blurred Vision; Weakness

  MAUDE report 7234017 ↗
• MalfunctionJan 26, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 165, 181, 145, 233 AND 165 MG/DL. CUSTOMER IS ALSO CONCERNED WITH ERRATIC BLOOD GLUCOSE TEST RESULTS FROM FASTING BACK TO BACK TESTS DONE DURING THE CALL ON (B)(6) 2018 OF 126 AND 151 MG/DL USING TRUETRACK METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 100 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 PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221824 ↗
• MalfunctionJan 22, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR: SAMPLE NOT DETECTED OR USING WRONG TEST STRIP. THE E-2 ERROR OCCURRED WHEN THE BLOOD SAMPLE IS ABSORBED. CUSTOMER'S DIABETES WAS RECENTLY DIAGNOSED. CUSTOMER GOT METER (B)(6) 2017 AND HAS NOT BEEN ABLE TO TEST HIS BLOOD SUGAR. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT DISCLOSED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF DRY MOUTH AND URINARY FREQUENCY. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL; CUSTOMER STATED HE WOULD TAKE HIS MEDICATION. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF 452 MG/DL USING TRUETRACK METER. CUSTOMER HAD JUST PURCHASED THE TEST STRIPS - MANUFACTURER'S EXPIRATION DATE IS 03/27/2020 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER WAS INSTRUCTED ON THE PROPER STORAGE LOCATIONS. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia; Urinary Frequency / Polyuria

  MAUDE report 7209346 ↗

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