TRUEtrack TRUEtrack BLOOD GLUCOSE METER - FREE METER ONLY (REF A4H01-88)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00021292001797), received between Nov 29, 2016 and Nov 15, 2018 — classified as 16 malfunctions.

The most frequently reported specific device problem is “High Test Results” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR CODE ECI METER. DURING THE CALL ON (B)(6) 2018, A CHECK STRIP TEST WAS PERFORMED. CUSTOMER REMOVED AND PROPERLY REINSERTED THE CODE CHIP AND TEST STRIP AND THE ERROR MESSAGE STILL DISPLAYED. A NEW VIAL OF TEST STRIPS WAS USED, SAME LOT NUMBER, AND THE ERROR MESSAGE STILL DISPLAYED. THE TEST STRIP MANUFACTURER'S EXPIRATION DATE IS 12/21/2020. AT THE TIME OF THE CALL, THE CUSTOMER WAS FEELING ILL AND REPORTED SYMPTOMS OF DIZZINESS AND NAUSEA. CUSTOMER STATED HE WOULD GO TO THE HOSPITAL. NO MEDICAL ATTENTION WAS REPORTED AT THE TIME OF THE CALL.

  Patient problems: Dizziness; Nausea

  MAUDE report 8073426 ↗
• MalfunctionMay 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DR.'S OFFICE STAFF MEMBER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 171 AND 238 MG/DL. DR.'S OFFICE STAFF MEMBER STATED THAT THE TRUETRACK METER IS ALSO READING HIGHER THAN THEIR HANDHELD METER WHICH HAD READ 123 MG/DL AND THE TRUETRACK HAD READ 179 MG/DL FASTING. 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) 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 06/21/2020 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 7475372 ↗
• MalfunctionApr 27, 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 200-368MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY. MEDICAL ATTENTION IS 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 NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 5/31/2020 AND OPEN VIAL DATE IS APPROXIMATELY 2-3 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). SPOKE WITH THE CUSTOMER AND THE HUSBAND THE CUSTOMER WAS FEELING DIZZY AND DID NOT WANT TO SPEAK TO ME. ON (B)(6) 2018, THE CUSTOMER SAID THE RESULTS WERE HIGH AND SHE CALLED THE DR AND HE TOLD HER TO GO TO THE ER. THEY DID TESTS ON HER ALL NEGATIVE THE RESULTS OF THE NON-FASTING LAB TEST WAS 318MG/DL THE TRUE TRACK SHE SAID WAS 384MG/DL N/FASTING AND THAT IS WHY SHE WANTS THE METER REPLACED SINCE THE HOSPITAL TOLD HER TO GET HER METER CALIBRATED OR REPLACED. THESE RESULTS COULD NOT BE CONFIRMED IN MET

  Patient problems: Dizziness

  MAUDE report 7469684 ↗
• MalfunctionApr 19, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT BEING FOUND UNRESPONSIVE. MEDICAL ATTENTION IS 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 BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS DATE AND OPEN VIAL DATE IS DATE. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CALLER CALLED IN TO THE TRAINING DEPARTMENT INQUIRING ABOUT HI. THE TRAINING DEPARTMENT PUT THE CUSTOMER'S INFORMATION ON THE OVERFLOW AND ADVISED CALLER TO CALL 911. CALLED CUSTOMER BACK AND CALLER STATES THEY FOUND THE CUSTOMER UNRESPONSIVE AND TESTED HER BLOOD SUGAR AND METER READ HI. AT THE TIME OF MY CALL CALLER STATES THE PARAMEDICS ARRIVED AND I OFFERED TO CALL HER BACK IN A FEW MINUTES. CALLED CUSTOMER BACK AND WENT TO VOICEMAIL. LEFT A MESSAGES REQUESTING A CALL BACK. PROVIDED CALL BACK NUMBER AND REFERENCE NUMBER. A 24 HOUR CALL BACK HAS BEEN ASSIGNED.

  Patient problems: Fainting; Hyperglycemia

  MAUDE report 7444312 ↗
• MalfunctionJan 24, 2018High 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 TEST RESULTS FROM RESULTS OBTAINED OF 254 AND 206 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 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 NON-FASTING AND PRODUCED TEST RESULTS OF 187 MG/DL AND 200 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/17/2020 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1 :161MG/DL DATE (B)(6) 2018 TIME:2:24 AM FASTING, RESULT 2 :163MG/DL DATE: (B)(6) 2018 TIME:3:00 AM FASTING, RESULT 3 :206MG/DL DATE: (B)(6) 2018 TIME:1:41 AM FASTING, RESULT 4 :254MG/DL DATE: (B)(6) 2018 TIME:7:20 AM FASTING, RESULT 5 :191MG/DL DATE: (B)(6) 2018 TIME:2:31 AM FASTING. THE CUSTOMER IS CALLING BECAUSE HE FEELS THAT THE RESULTS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7215038 ↗
• MalfunctionNov 21, 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 172, 182, 223, 153 AND 167 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 107 - 120 MG/DL. CUSTOMER STATED THE HE HAS BEEN OBTAINING THE HIGH RESULTS SINCE HE STARTED USING THE TEST STRIPS TWO - THREE WEEKS AGO. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT HE HAD GONE TO THE DOCTOR FOR HIS NORMAL VISIT AND TOLD THE DOCTOR ABOUT THE METER. THE DOCTOR HAD DONE BLOOD WORK; CUSTOMER COULD NOT REMEMBER WHAT THE RESULTS WERE BUT STATED THAT THE DOCTOR TOOK HIM OFF HIS HIGH DOSAGE OF METFORMIN SINCE HIS BLOOD WORK WAS GOOD. DURING THE CALL ON (B)(6) 2017, 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 06/21/2019 AND OPEN VIAL DATE AT TIME OF CALL IS TWO - THREE WEEKS. CUSTOMER HAD THE CORRECT CODE CHIP IN THE METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 172 MG/DL DATE: (B)(6) 2017TIME:1:18PM FASTING,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048485 ↗
• MalfunctionAug 24, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL GLUCOSE TEST RESULTS. CUSTOMER ALSO STATED THAT HER BLOOD GLUCOSE RESULTS WERE RUNNING HIGHER THAN NORMAL. THE CUSTOMER IS CONCERNED WITH BLOOD TEST RESULTS FROM RESULTS OBTAINED OF 338, 135 AND 422 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/27/2018 AND OPEN VIAL DATE IS ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): 338MG/DL (B)(6) 2017 11:22 PM FASTING:YES, 135MG/DL (B)(6) 2017 07:40 AM FASTING:YES, 422MG/DL (B)(5) 2017 11:09 PM FASTING:YES, 171MG/DL (B)(6) 2017 07:20 AM FASTING:YES, 119MG/DL (B)(6) 2017 12:30 PM FASTING:YES, MEMORY CONCERNS:UNDISCLOSED. CUSTOMER CALLED REGARDING HIGH RESULTS THAT SHE IS GETTING FROM HER METER ON A CONTROL SOLUTION TEST. DATE AND TIME IS NOT CURRENTLY SET UP CORRECTLY IN THE CUSTOMERS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816446 ↗
• MalfunctionJul 6, 2017Low Test Results; Device Displays Incorrect Message; Low Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR. CUSTOMER IS FEELING WELL AT THIS TIME. THE ERROR APPEARED AS SOON AS THE TEST STRIP WAS INSERTED IN THE METER. THE TEST STRIPS WERE OPEN 10 DAYS AGO. CUSTOMER LEFT THE CONTAINER OF TEST STRIPS OPEN BUT STORES THE PRODUCTS IN HIS STUDY ROOM. THE CUSTOMER STATED IT WAS OPEN SINCE (B)(6) 2015.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6691657 ↗
• MalfunctionJun 30, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER BELIEVED HER RESULTS WERE INCONSISTENT BECAUSE SHE FELT THEY WERE LOW. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70-110MG/DL. EVEN THOUGH HER RESULTS HAVE BEEN WITHIN HER EXPECTED RESULTS CUSTOMER PREFERRED METER BEING REPLACED. RAN BLOOD TEST WITH ME FASTING 95MG/DL. CUSTOMER HAS NOT NEEDED MEDICAL ATTENTION AND IS NO EXPERIENCING ANY SYMPTOMS OF LOW BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 95MG/DL, (B)(6)2016 12:32:00 PM, FASTING:YES. A 84MG/DL, (B)(6)2016 12:44:00 PM, FASTING:YES. A 81MG/DL, (B)(6)2016 01:03:00 PM, FASTING:YES. A 96MG/DL, (B)(6)2016 08:06:00 AM, FASTING:YES. A 76MG/DL, (B)(6)2016 07:58:00 AM, FASTING:YES. MEMORY CONCERNS:CUSTOMER IS CONCERNED ABOUT HER RESULTS BEING LOW EVEN THOUGH RESULTS WE VIEWED FROM THE MEMORY ARE WITHIN HER EXPECTED RESULTS OF 70-110MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6681567 ↗
• MalfunctionJun 23, 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 244 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 160 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 NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/29/2019 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 6664695 ↗
• MalfunctionJun 1, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 77, 87 AND 85 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99 - 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 NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM CABINET. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/14/2017 AND OPEN VIAL DATE AT TIME OF CALL IS ONE MONTH; STRIPS ARE PART OF RECALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): A 77MG/DL, (B)(6) 2017 05:15 PM, FASTING:YES. A 87MG/DL, (B)(6) 2017 06:07 PM, FASTING:YES. A 85MG/DL, (B)(6) 2017 08:27 AM, FASTING:YES. MEMORY CONCERNS: CUSTOMER IS CONCERNED WITH THE RESULTS OF 77, 87, 85 MG/DL FROM THE METERS MEMORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6604718 ↗
• MalfunctionMay 25, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. SARAH (WIFE) IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 455 AND 466 MG/DL. THE CUSTOMER'S EXPECTED FASTING NON-FASTING) BLOOD GLUCOSE TEST RESULT RANGE IS 200 MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF FREQUENT URINATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON 05/01/2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 466 AND 462MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017 THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CUSTOMER IS CONCERNED WITH HIGH READINGS. RESULT OF CONCERN IS 455MG/DL FASTING.

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 6590679 ↗
• MalfunctionMay 11, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 96 TO 107MG/DL. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/21/2019 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). THE CUSTOMER HAS NOT HAD ANY CHANGES IN HER DIET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6561756 ↗
• MalfunctionJan 30, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON OF 288 MG/DL USING TRUETRACK METER AND 175 MG/DL USING DR.'S DEVICE. THE CUSTOMER WAS ALSO CONCERNED WITH THE REST OF THE READINGS IN THE METER'S MEMORY INCLUDING 503 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS ANYWHERE BELOW 200 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/22/2017 AND OPEN VIAL DATE IS 11/22/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: ALL READINGS IN METER MEMORY ARE OF CONCERN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6286386 ↗
• MalfunctionJan 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 397 AND 361MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 115MG/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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 114 AND 135MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): A 112MG/DL, (B)(6) 2016 12:00 AM, FASTING: YES. A 397MG/DL, (B)(6) 2016 12:00 AM, FASTING: YES. A 361MG/DL, (B)(6) 2016 12:00 AM, FASTING: YES. A 178MG/DL, (B)(6) 2016 12:00 AM, FASTING: YES. A 166MG/DL, (B)(6) 2016 12:00 AM, FASTING: YES. DATES AND TIMES ARE SUBJECTIVE TO THE CUSTOMER'S RECORDS. CUSTOMER HAS ISSUES WITH HER VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6228986 ↗
• 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 ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 100 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION,CUSTOMER STORES THE PRODUCT IN THE KITCHEN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2018 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 6132842 ↗

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