TRUEtrack TRUEtrack Blood Glucose Monitoring System (REF A4007-81)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00050428264706), received between Jan 12, 2017 and Oct 3, 2018 — classified as 41 malfunctions.

The most frequently reported specific device problem is “High Test Results” (25 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 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 186, 190, 165, 199 AND 257 MG/DL. CUSTOMER ALSO STATED THAT THE TRUETRACK METER IS READING 30 POINTS HIGHER THAN HIS DOCTORS HANDHELD METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 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. 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 02/16/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :186MG/DL DATE: (B)(6) 2018 TIME:09:41AM FASTING; RESULT 2 :190MG/DL DATE: (B)(6) 2018 TIME:06:30AM FASTING; RESULT 3 :165MG/DL DATE: (B)(6) 2018 TIME:11:30AM FASTING; RESULT 4 :199MG/DL DATE: (B)(6) 2018 TIME:07:18AM FASTING; RESULT 5 :257MG/DL DATE: (B)(6) 2018 TIME:02:53PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7932098 ↗
• MalfunctionJul 30, 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 166, 215, 344, 339 AND 156 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 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 NOT PERFORMED BY CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2020 AND OPEN VIAL DATE IS TWO-THREE WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7730962 ↗
• MalfunctionJul 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 272, 288 AND 205 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 NOT PERFORMED BY THE CUSTOMER. HIGH BLOOD GLUCOSE RESULTS WERE OBTAINED USING TEST STRIP LOT NUMBER RU5180. CUSTOMER STATED STRIPS ARE STORED IN THE DINING ROOM BUT THAT THIS VIAL OF TEST STRIPS WAS LEFT IN HIS CAR FOR FOUR HOURS ON (B)(6) 2018 WHILE HE WENT TO A DOCTOR'S APPOINTMENT. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/16/2020 AND OPEN VIAL DATE WAS UNDISCLOSED. A NEW VIAL OF TEST STRIPS, LOT NUMBER RU5216, MANUFACTURER'S EXPIRATION DATE OF 06/19/2020, WAS OPENED DURING CALL TO PERFORM CONTROL TEST. CUSTOMER ALSO STATED THAT AT TIMES HE TURNS OFF HIS AIR CONDITIONING AND USES A FAN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7687046 ↗
• MalfunctionJul 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 532, 575, 424, 456 AND 389MG/DL. 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 STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 389 AND 456MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/19/2020 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 7663879 ↗
• MalfunctionJul 3, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 451MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING FATIGUE AND EXCESSIVE THIRST. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 451MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/19/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. ONLY CONDUCTED ONE GLUCOSE TEST AT TIME OF CALL DUE TO SYMPTOMS AND RESULT WAS 451MG/DL FASTING. CUSTOMER WAS NOT FEELING WELL AND WILL SEEK MEDICAL ATTENTION.

  Patient problems: Fatigue; Polydipsia

  MAUDE report 7659809 ↗
• MalfunctionJun 28, 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 102, 166, 151 AND 298 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 81 - 97 MG/DL. CUSTOMER STATED HE HAS ONLY BEEN USING THE TRUETRACK METER FOR ABOUT A MONTH. 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 135 MG/DL AND 153 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE CLOSET. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/22/2019 AND OPEN VIAL DATE IS 2 WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:163MG/DL DATE: (B)(6) 2018 TIME:8:37AM FASTING, RESULT 2:201MG/DL DATE: (B)(6) 2018 TIME:10:26AM FASTING, RESULT 3:114MG/DL DATE: (B)(6) 2018 TIME:7:29AM FASTING, RESULT 4:298MG/DL DATE: (B)(6) 2018 TIME:3:57PM FASTING, RESULT 5:151MG/DL DATE: (B)(6) 2018 TIME:3:49PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7645873 ↗
• MalfunctionJun 1, 2018High Test Results; High Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR BEING UNABLE TO OBTAIN A BLOOD GLUCOSE TEST RESULT. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER WAS INSTRUCTED TO INSERT CODE CHIP INTO THE METER AND A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING THAT PRODUCED TEST RESULTS OF HI AND HI USING TRUETRACK METER. SISTER STATED THE CUSTOMER HAD TAKEN FAST ACTING INSULIN ABOUT 20 MINUTES PRIOR TO THE BACK TO BACK TESTS THAT WERE PERFORMED DURING THE CALL. SISTER STATED THE CUSTOMER WAS SLEEPY AND THAT HE WAS ALSO SHAKY. SISTER STATED SHE WOULD TAKE THE CUSTOMER TO THE HOSPITAL.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Shaking/Tremors

  MAUDE report 7560722 ↗
• MalfunctionMay 8, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULT OBTAINED OF HI AND METER TO METER COMPARISON OF 419 MG/DL USING TRUETRACK METER AND 111 MG/DL USING DR.'S DEVICE; CUSTOMER STATED METER TO METER COMPARISON TESTS WERE PERFORMED FASTING AND WITHIN TWENTY MINUTES. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 300 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 STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/30/2019 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 7496936 ↗
• MalfunctionMay 7, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR CODE (----) ECI METER. THE METER READ CODE (----) AS SOON AS THE TEST STRIP WAS INSERTED. THE CODE CHIP MATCHED THE TEST STRIP. CUSTOMER DID NOT HAVE A NEW VIAL OF TEST STRIPS. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AFTER REINSERTING THE CODE CHIP AND PRODUCED TEST RESULT OF 89 MG/DL USING TRUETRACK METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING SHAKY; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. COMPLAINT RESOLVED DURING THE CALL.

  Patient problems: Shaking/Tremors

  MAUDE report 7491848 ↗
• MalfunctionApr 23, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM NON-FASTING RESULTS OBTAINED OF 70, 50 AND 51 MG/DL. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 125 MG/DL; EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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 ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT WAS NOT STORED ACCORDING TO SPECIFICATION - CUSTOMER STATED THAT HE LEFT THE TEST STRIPS IN THE CAR TRUNK OVERNIGHT (8 - 9 HOURS) AND THE TEMPERATURE WAS BELOW 30 DEGREES. CUSTOMER STATES THAT SINCE, THE METER HAS BEEN GIVING HIM LOW RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS (B)(6) 2018. TEST STRIPS ARE NOT IMPACTED BY RECALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450500 ↗
• MalfunctionApr 12, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID 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 BEDROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HIL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/24/2019 AND OPEN VIAL DATE IS APPROXIMATELY ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1 : HI DISPLAY, DATE: (B)(6) 2018, TIME: 4:58 PM, FASTING. RESULT 2 : HI DISPLAY, DATE: (B)(6) 2018, TIME: 5:36 PM, FASTING. CUSTOMER CALLED IN STATES THE METER IS READING HI DISPLAY. CUSTOMER STATES HE WENT TO THE HOSPITAL 2 WEEKS AGO AND HAS NEVER BEEN DIAGNOSED WITH DIABETES. CUSTOMER STATES HE WAS NOT FEELING WELL AND WHEN HE GOT TO THE HOSPITAL 2 WEEKS AGO AND HIS GLUCOSE WAS 640 MG/DL NON-FASTING USING THE HOSPITAL'S METER. CUSTOMER WAS NOT USING A METER AT THE TIME OF HOSPITALIZATION AND HAS NOT BEEN DIAGNOSED WITH DIABETES AS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7425006 ↗
• MalfunctionMar 20, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED HOWEVER THE CUSTOMER DID PROVIDE A RECENT AIC OF 7.6% (171 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 NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 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). RIGHT BEFORE HIS TESTS HE TESTED 127 MG/DL FASTING ON HIS METER AND THEN TESTED 187 MG/DL FASTING FROM VENOUS BLOOD IN THE LAB. CUSTOMER IS CONCERNED THAT HIS METER MAY BE READING LOWER THAN NORMAL. DUE TO HIS RESULTS ON THE METER HE WAS EXPECTING A MUCH LOWER A1C RESULT AND HE OBTAINED AN A1C OF 7.6 (171 MG/DL). CUSTOMER STATES THAT HE ALSO TESTED 42 AND 46 MG/DL FASTING ON TWO OCCASIONS. CUSTOMER STATES HE WAS FEELING SHAKY, HOWEVER, EXPECTED A READING OF 80 MG/DL SINCE HE WOULD NORMALLY FEEL SYMPTOMS OF HYPOGLYCEMIA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7352918 ↗
• MalfunctionMar 8, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. ANOTHER PERSON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130-160 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 BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 361 MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 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 7323538 ↗
• MalfunctionFeb 22, 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 207, 225, 183 AND 192 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 120 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 04/16/2020 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :130MG/DL DATE: (B)(6) 2018 TIME:12:13PM FASTING, RESULT 2 :207MG/DL DATE: (B)(6) 2018 TIME:12:11PM FASTING, RESULT 3 :225MG/DL DATE: (B)(6) 2018 TIME:12:09PM FASTING, RESULT 4 :183MG/DL DATE: (B)(6) 2018 TIME:12:09PM FASTING RESULT 5 :192MG/DL DATE: (B)(6) 2018 TIME:12:08PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7290425 ↗
• MalfunctionJan 16, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 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, 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 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2017; CUSTOMER'S TEST STRIPS ARE EXPIRED - AT THE TIME OF THE CALL THEY ARE FOUR MONTHS PAST THE DATE FIRST OPENED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7197858 ↗
• MalfunctionJan 12, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR CODE (----) ECI METER. CUSTOMER WAS GETTING CODE (----) WHEN THE TEST STRIPS WERE INSERTED INTO THE METER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING FATIGUED AND FELT THAT IT WAS RELATED TO HIS BLOOD GLUCOSE BEING ELEVATED. CUSTOMER HAS NOT BEEN DIAGNOSED WITH DIABETES AND JUST BOUGHT THE TRUETRACK METER DUE TO FEELING FATIGUED. CUSTOMER STATED HE WAS GOING TO GO TO THE EMERGENCY ROOM. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING USING A NEW VIAL OF TEST STRIPS AND PRODUCED TEST RESULT OF 541 MG/DL USING TRUETRACK METER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue

  MAUDE report 7185579 ↗
• MalfunctionDec 5, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS WHICH CUSTOMER STATES IS NOT RELATED TO HIS DIABETES. (B)(6), WIFE, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-16MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING TIRED BUT ATTRIBUTES THIS TO LACK OF SLEEP AND BREATHING PROBLEMS. 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) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 461 AND 415MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS TWO MONTHS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): (B)(6). CUSTOMER IS CONCERNED WITH HIGH RESULTS. BUT IN THE LAST FEW WEEKS, WITHOUT ANY CHANGES IN HIS DIET EXERCISE ROUTINE OR MEDICATION, METER IS GIVEN HIGH RESULTS. INFORMED CUSTOMER THAT CODE CHIPS MUST BE CHANGE

  Patient problems: Fatigue

  MAUDE report 7084998 ↗
• MalfunctionNov 20, 2017High Test Results; High Test Results

  DAUGHTER CALLED ABOUT HER MOM GOING TO THE HOSPITAL, ON SATURDAY (B)(6) 2017, AFTER THE METER READ MUCH HIGHER ON HER BLOOD RESULTS THAN THE PARAMEDICS METER. THE DAUGHTER SAID HER MOM'S BLOOD WAS LOW AND SHE CALLED THE PARAMEDICS. THE RESULT ON THE PARAMEDIC'S METER WAS ROUGHLY 40MG/DL. THEY GAVE HER SOME GLUCOSE BY IV. LATER THAT DAY SHE HAD TO CALL THEM BACK LATER AGAIN BECAUSE HER MOM WAS NOT FEELING WELL (SWEATING AND VERY LIFELESS). THE PARAMEDICS CAME OUT AGAIN ABOUT 2 HOURS LATER. SHE SAID THE BLOOD SUGAR WAS 14MG/DL AND SHE THOUGHT THE TRUE TRACK METER READ 152MG/DL BUT SHE IS NOT SURE. THE RESULTS THAT WERE DONE ON (B)(6) 2017 ARE ALL LOW. HER MOM WHO IS STILL IN THE HOSPITAL BECAUSE THE DOCTOR CANNOT GET HER BLOOD STABLE. HER BLOOD SUGARS KEEPS DROPPING AND THEY CANNOT FIND OUT WHY. THEY ARE TRYING TO GET HER MEDICATION UNDER CONTROL THIS TIME BEFORE THEY LET HER GO. THE DAUGHTER STATED THAT TAKING BLOOD SUGARS IS ALL LOW TO HER. SHE DID NOT HAVE THE RIGHT CODE IN HER METER FOR THE LOT NUMBER OF STRIPS THAT SHE IS USING. I EXPLAINED THE NEED TO HAVE THE RIGHT CODE IN AND SHE NO LONGER HAS THE CODE CHIP FOR THE STRIPS SHE IS CORRECTLY USING. I REVIEWED THE STORAGE, THE A

  Patient problems: Sweating

  MAUDE report 7046769 ↗
• MalfunctionNov 14, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM FASTING METER TO METER COMPARISON OF 350 MG/DL USING TRUETRACK METER AND 94 MG/DL USING DR.'S DEVICE. THE CUSTOMER IS ALSO CONCERNED WITH RESULTS OBTAINED OF 233 AND 134 MG/DL. THE CUSTOMER STATED HE IS NOT DIABETIC AND THAT HIS EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 60 - 115 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER STATED THAT ABOUT THREE WEEKS PRIOR TO THE CALL HE FELT THAT THE METER WAS GIVING HIGH RESULTS. THE CUSTOMER WENT TO SEE HIS DOCTOR DUE TO HIS CONCERN ABOUT THE HIGH RESULTS OBTAINED. THE CUSTOMER DID NOT REPORT ANY SYMPTOMS OR ILLNESS, HE WAS ONLY CONCERNED WITH THE HIGH RESULTS AND THAT LEAD HIM TO CONTACT HIS DOCTOR. THE CUSTOMER DID NOT RECEIVE ANY TREATMENT WHILE AT THE DOCTOR'S OFFICE. THE DOCTOR RECOMMENDED THAT A DIFFERENT METER BE USED. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; THE CUSTOMER DID NOT HAVE ANY TEST STRIPS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (RESULT OF 350 MG/DL WAS NOT CONFIRMED IN THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7029272 ↗
• MalfunctionOct 20, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE E-3 ERROR OCCURRED AS SOON AS THE TEST WAS INSERTED INTO THE METER. THE CUSTOMER IS TESTING CORRECTLY. THE CUSTOMER STATED SHE HAD NOT LEFT THE STRIP OUT OF THE VIAL TOO LONG AND DID NOT LEAVE THE STRIP VIAL OPEN. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF DRY MOUTH AND INCREASED THIRST. THE CUSTOMER DECLINED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER ATTEMPTED TO RETEST USING A NEW TEST STRIP AND OBTAINED A RESULT OF E-3 USING TRUETRACK METER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/15/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Code Available; Polydipsia

  MAUDE report 6965071 ↗
• MalfunctionSep 20, 2017High 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 423 MG/DL. CUSTOMER STATED HE HAD PERFORMED A FASTING BACK TO BACK METER COMPARISON BLOOD GLUCOSE TEST AND OBTAINED RESULTS OF 423 MG/DL USING THE TRUETRACK METER AND 120 MG/DL USING ANOTHER DEVICE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 250 MG/DL. CUSTOMER STATED HIS RESULTS HAVE NEVER BEEN 120 MG/DL FASTING, SO HE IS NOT SURE ABOUT EITHER METER. 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 CUSTOMER HAD EXPIRED TEST STRIPS AND DID NOT HAVE ANY ADDITIONAL STRIPS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/28/2018 AND OPEN VIAL DATE AT TIME OF CALL IS FIVE MONTHS. CUSTOMER STATED HE HAD NOT TESTED WITH THE TRUETRACK METER IN OVER FIVE MONTHS AND HAD THE SAME OPEN VIAL OF TEST STRIPS; CUSTOMER'S TEST STRIPS ARE EXPIRED AS AT THE TIME OF THE CALL THEY ARE 120 DAYS AFTER T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6879305 ↗
• MalfunctionSep 5, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR READING OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 TO 300MG/D. THE CUSTOMER 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. 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 550 AND 546 MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/13/2019 AND OPEN VIAL DATE IS 08/15/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER REFUSED TO GO THE HOSPITAL; SHE STATED THAT SHE FELT FINE AND THAT SHE WOULD CALL MD. SHE WANTED TO EXERCISE AND BRING DOWN HER BLOOD SUGAR. SHE CONTINUED TO STATE THAT SHE HAD TAKEN HUMALOG AND THAT IT HAD NOT TAKEN EFFECT. CUSTOMER STATED THAT SHE WOULD CALL HER MD. SHE STATED, THIS IS NORMAL FOR HER TO RUN VERY HIGH. CUSTOMER STATED THAT SHE HAD CALLED BECAUSE SHE THOUGHT THAT THE METER WAS BROKEN BECAUSE IT WAS GIVING DIFFERENT BACK TO BACK NUMBERS. CUSTOMER DID TWO BACK TO BACK TESTS WITH NEW STRIPS THAT W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6842178 ↗
• MalfunctionAug 29, 2017Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE METER DID NOT TURN ON BY INSERTING A TEST STRIP. WHEN THE S BUTTON WAS MANUALLY PRESSED, THE METER WOULD TURN ON AND THE AVERAGES WOULD DISPLAY. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL ON (B)(6) 2017, THE CUSTOMER REPORTED FEELING A LITTLE DIZZY; CUSTOMER HAD NOT EATEN IN FOUR HOURS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/14/2019 AND OPEN VIAL DATE IS (B)(6) 2017. DURING THE CALL, WIFE STATED SHE HAD ANOTHER VIAL OF STRIPS, LOT# RT4944, EXPIRATION DATE OF 01/13/2019; CUSTOMER INSERTED A TEST STRIP INTO THE METER AND CODE 4944 APPEARED AND WENT TO THE BLOOD DROP. CUSTOMER THEN PERFORMED A BLOOD TEST AND OBTAINED A RESULT OF 148 MG/DL FASTING USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness

  MAUDE report 6828509 ↗
• MalfunctionJul 20, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. FAMILY MEMBER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER STATES RELATIVE FEELS PHYSICALLY WELL, HOWEVER HAS SOME EYE ISSUES THAT IS RELATED TO THEIR DIABETES - NO MEDICAL ASSISTANCE NECESSARY BY CUSTOMER. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS UNDISCLOSED AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CONCERN WITH E-3 ERRORS ON BEHALF OF RELATIVE. CUSTOMER DOES NOT HAVE TESTING SUPPLIES ON HAND AND IS NOT WITH END USER TO VERIFY FURTHER INFORMATION.

  Patient problems: Blurred Vision

  MAUDE report 6729456 ↗
• MalfunctionJul 18, 2017Device 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 AFTER THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL ON (B)(6)2017, THE CUSTOMER REPORTED FEELING TIRED AND THAT IT MAY BE DUE TO HER THYROID. DURING THE CALL ON (B)(6)2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 78 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2018 AND OPEN VIAL DATE IS (B)(6) 2016. BASED ON STRIP OPEN DATE PROVIDED OF (B)(6)2016, CUSTOMER'S STRIPS ARE EXPIRED - AT THE TIME OF THE CALL THEY ARE FOUR MONTHS PAST THE DATE FIRST OPENED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue

  MAUDE report 6721401 ↗

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