TRUEtrack TRUEtrack 25 Blood Glucose Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00021292008888), received between Jan 27, 2017 and Oct 12, 2021 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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.

• InjuryOct 12, 2021Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE. DURING THE CALL, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. CUSTOMER HAS DISCONTINUED PRODUCT - CUSTOMER HAS TRUE2GO METER. CUSTOMER WAS ALSO USING TRUETRACK TEST STRIPS WITH THE TRUE2GO METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/31/2022 AND OPEN VIAL DATE IS 09/16/2021. PRODUCT STORAGE LOCATION WAS NOT DISCLOSED. THE CUSTOMER STATED SHE HAD NOT BEEN TESTING HER BLOOD GLUCOSE FOR A LONG PERIOD OF TIME. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED EXPERIENCING DRY MOUTH; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. CUSTOMER WAS UPGRADED TO TRUE METRIX GO PRODUCT LINE.

  Patient problems: Dry Mouth

  MAUDE report 12614588 ↗
• MalfunctionJul 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE READINGS AND STRIPS READING IN MMOL BUT LABELED FOR MG/DL. CUSTOMER ADVISED THAT HER BROTHER PURCHASES THE STRIPS FROM THE US AND THEN BRINGS THEM TO HER IN CANADA AND THAT HE HAS BEEN DOING THAT FOR MORE THAN A YEAR. THE CUSTOMER IS CONCERNED WITH ALL TEST RESULTS OBTAINED. CUSTOMER WAS ADVISED THAT CANADA USES THE MMOL UNIT OF MEASURE AND THAT THE US USES MG/DL. ADVISED CUSTOMER THAT SHE SHOULD BE PURCHASING HER STRIPS IN CANADA DUE TO THE UNIT OF MEASURE AS SHE WANTS TO MAKE SURE THAT SHE IS GETTING ACCURATE RESULTS. CUSTOMER UNDERSTANDS AND ADVISED THAT IT IS A COST ISSUE FOR HER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 9.0MMOL/L. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/18/2022 AND OPEN VIAL DATE IS THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323705 ↗
• MalfunctionApr 8, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  CONSUMER REPORTED COMPLAINT FOR MISSING PACKAGE ITEM, STATING THAT THE VIAL OF TEST STRIPS SHE HAD PURCHASED WAS MISSING THE CODE CHIP. CUSTOMER STATED THAT THE SEAL WAS ON THE TEST STRIP VIAL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO PAST MEDICAL ATTENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938338 ↗
• InjuryMar 24, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR CODE. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2021 AND OPEN VIAL DATE IS (B)(6) 2020. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 380 MG/DL USING TRUETRACK METER. CUSTOMER WAS SATISFIED WITH THE BLOOD GLUCOSE TEST RESULT OBTAINED, STATING SHE BELIEVED IT TO BE ACCURATE AS SHE WAS FEELING DROWSY AT TIME OF CALL IN RELATION TO HER DIABETES. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL.

  Patient problems: Fatigue

  MAUDE report 9872185 ↗
• MalfunctionJan 16, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  CONSUMER REPORTED COMPLAINT FOR MISSING PACKAGE ITEMS. CUSTOMER STATED THAT WHEN SHE OPENED THE TRUETRACK KIT, THE VIAL OF TEST STRIPS ONLY CONTAINED EIGHT (TWO WERE MISSING) AND THAT THE CODE CHIP WAS ALSO MISSING. CUSTOMER STATES THAT THE PACKAGE WAS SEALED AND NOT OPENED AND THAT IT DID NOT LOOK TAMPERED WITH. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION WAS REQUIRED AT AN EARLIER TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595973 ↗
• MalfunctionSep 30, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OBTAINED OF OVER 270MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDER 270MG/DL. THE CUSTOMER DID REPORT DIABETIC SYMPTOMS OF COTTON MOUTH, DIZZINESS, FATIGUE AND INCREASED URINATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 565MG/DL AND 553MG/DL FASTING USING METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/26/2020 AND OPEN VIAL DATE IS 9/5/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: Dizziness; Fatigue; Urinary Frequency / Polyuria

  MAUDE report 9134792 ↗
• MalfunctionMar 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. NIECE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 150MG/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 REFUSED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :HI DATE:(B)(6) 2018 TIME:6:05PM FASTING, RESULT 2 :HI DATE:(B)(6) 2018 TIME:2:14PM FASTING, RESULT 3 :HI DATE:(B)(6) 2018 TIME:1:53PM FASTING, RESULT 4 :274MG/DL DATE:(B)(6) 2017 TIME:1:20PM FASTING, RESULT 5 :223MG/DL DATE:(B)(6) 2018 TIME:1:51PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7306010 ↗
• MalfunctionFeb 14, 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 501 AND 232 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 125 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 196 MG/DL AND 212 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE FAMILY ROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :232MG/DL DATE: (B)(6) 2018TIME:09:02AM FASTING, RESULT 2 :117MG/DL DATE: (B)(6) 2018TIME:02:48AM FASTING, RESULT 3 :137MG/DL DATE: (B)(6) 2018TIME:02:40AM FASTING, RESULT 4 :128MG/DL DATE: (B)(6) 2018TIME:02:48AM FASTING, RESULT 5 :501MG/DL DATE: (B)(6) 2018TIME:08:24AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7271596 ↗
• MalfunctionFeb 2, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED RESULTS OF 188, 169, 181 AND 196MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 150MG/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 BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 171 MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/13/2020 AND OPEN VIAL DATE IS A WEEK AGO. 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 7235634 ↗
• MalfunctionDec 21, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING WEAK AND HAVING A HEADACHE. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 5/31/2019 AND OPEN VIAL DATE IS ABOUT A MONTH AGO.THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:427MG/DL DATE:(B)(6) 2017 TIME:6:47AM FASTING, RESULT 2:457MG/DL DATE:(B)(6) 2017 TIME:3:25AM FASTING, RESULT 3:280MG/DL DATE:(B)(6) 2017 TIME:8:33PM NON FASTING, RESULT 4:413MG/DL DATE:(B)(6) 2017 TIME:3:14PM NON FASTING, RESULT 5:514MG/DL DATE:(B)(6) 2017 TIME:9:10PM FASTING, RESULT 6:317MG/DL DATE:(B)(6) 2017 TIME:7:31 UNKNOWN, RESULT 7:543MG/DL DATE:(B)(6) 2017 TIME:6:53PM FASTING, RESULT 8:584MG/DL DATE:(B)(6) 2017 TIME:1:34PM NON FASTING, RESULT 9:475MG/DL DATE:(B)(6) 2

  Patient problems: Headache; Weakness

  MAUDE report 7140537 ↗
• MalfunctionNov 15, 2017Device 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 SYMPTOM OF FEELING SHAKY. 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) 2017, A BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-3 USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. METER READ E-3. CUSTOMER FEELS PHYSICALLY ILL (SHAKY) AS SOON AS THE STRIP IS INSERTED. CUSTOMER JUST PURCHASED A VIAL OF TEST STRIPS FROM (B)(6), MULTIPLE OF THE STRIPS ARE READING E-3, CUSTOMER DECLINE REPLACEMENT AT THIS TIME, SHE STATES THAT SHE WILL TAKE THE STRIPS BACK TO (B)(6) AND HAVE THEM REPLACE THEM

  Patient problems: Shaking/Tremors

  MAUDE report 7035559 ↗
• MalfunctionJul 18, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULT OF 442MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 124 TO 134MG/DL. 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 232 AND 268MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/15/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY) 181MG/DL (B)(6) 2017 02:15 PM FASTING: YES; 204MG/DL (B)(6) 2017 11:52 PM FASTING: YES; 442MG/DL (B)(6) 2017 02:50 PM FASTING: YES; 150MG/DL (B)(6) 2017 08:40 PM FASTING: YES; 224MG/DL (B)(6) 2017 10:01 PM FASTING: YES. CUSTOMER CALLED IN AND STATES THAT THE METER IS READING TOO HIGH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6721746 ↗
• MalfunctionJul 12, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW RESULTS. CUSTOMER'S EXPECTED RESULTS ARE 90-100MG/DL - FASTING. STRIP EXPIRATION DATE IS 07/31/2017 AND STRIP OPEN DATE IS (B)(6) 2015. STRIP STORAGE IS CORRECT. BACK TO BACK BLOOD TEST PERFORMED ADN RESULTS ARE 60MG/DL AND 68MG/DL - FASTING. REVIEWED METER MEMORY (TIME NOT SET): 64MG/DL (B)(6) 2015 01:10:00 PM FASTING:YES; 67MG/DL (B)(6) 2015 01:08:00 PM FASTING:YES; 184MG/DL (B)(6) 2015 11:33:00 AM FASTING:YES; 164MG/DL (B)(6) 2015 10:13:00 AM FASTING:YES; 133MG/DL (B)(6) 2015 08:32:00 PM FASTING:YES. CUSTOMERS CONCERN: 64 MG/DL ON (B)(6) 2015 AND 67 MG/DL. THE CUSTOMER IS TESTING TWICE A DAY (FASTING) AND IS NOT ON ANY MEDICATION OR HAS MADE ANY CHANGES IN HER DIET. THE CUSTOMER IS FEELING FINE. THE CUSTOMER IS STORING THE METER IN THE LIVING ROOM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6705570 ↗
• MalfunctionJul 6, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW RESULTS. CUSTOMER REPORTED NO SYMPTOMS, AND DOES NOT NEED MEDICAL ATTENTION. STRIP EXPIRATION DATE IS 11/30/2017 AND STRIP OPEN DATE IS (B)(6)2015. STRIP STORAGE IS CORRECT. BACK TO BACK BLOOD TEST PERFORMED WITH RESULTS OF 101MG/DL AND 104MG/DL - FASTING. REVIEWED METER MEMORY: A 107MG/DL, (B)(6)2015 05:35:00 PM FASTING:YES. A 113MG/DL, (B)(6)2015 05:26:00 PM FASTING:YES. A 133 MG/DL, (B)(6)2015 05:15:00 PM FASTING:YES. A 168MG/DL, (B)(6)2015 05:12:00 PM FASTING:YES. A 129MG/DL, (B)(6)2015 05:11:00 PM FASTING:YES. MEMORY CONCERNS: CUSTOMER MAIN CONCERN ARE RESULTS LOWER THAN 120MG/DL. CUSTOMER STATED SHE RECENTLY STOPPED TAKING HER MEDICATION FOR DIABETES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6691083 ↗
• MalfunctionFeb 17, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER STATING THAT NEW METER RECEIVED THIS WEEK IS GIVING HIGH READINGS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 507 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170 - 200 MG/DL. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. DAUGHTER STATED CUSTOMER'S METER READ 507 MG/DL FASTING AT 8:10 PM ON (B)(6) 2017. DAUGHTER STATED THE CUSTOMER WAS TAKEN TO THE HOSPITAL AND AT 9:00 PM HER BLOOD SUGAR METER RESULT WAS 187 MG/DL AND THE LAB RESULT WAS 174 MG/DL. DAUGHTER STATED NO INTERVENTION WAS RECEIVED AT THE HOSPITAL AND THE CUSTOMER WAS RELEASED. 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 337 MG/DL USING TRUETRACK METER AND 284 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/15/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER'S DAUGHTER STATES T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6339095 ↗
• MalfunctionJan 27, 2017Incorrect 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 107, 128 AND 105 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 110 MG/DL. DURING THE CALL ON (B)(6) 2016, THE CUSTOMER STATED SHE FELT WEAK AND A LITTLE DIZZY. THE CUSTOMER STATED SHE HAD NOT EATEN AND WANTED TO GO TO THE HOSPITAL TO MAKE SURE HER GLUCOSE LEVELS WERE OK. THE CUSTOMER STATED THAT SHE IS PRE-DIABETIC AND HAS BEEN MONITORING HER GLUCOSE LEVELS FOR A FEW YEARS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED AS THE CUSTOMER STATED SHE HAS BOUGHT AND WASTED SO MANY STRIPS AND HAD NO MORE. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS A MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 105MG/DL (B)(6) 2016 03:01 PM FASTING: YES; 126MG/DL (B)(6) 2016 02:59 PM FASTING: YES; 107MG/DL (B)(6) 2016 02:27 PM FASTING: YES; 128MG/DL (B)(6) 2016 02:27 PM FASTING: YES; 19MG/DL (B)(6) 2016 01:56 PM FASTING: YES. MEMORY CONCERNS:126MG/DL. PATIENT STATE

  Patient problems: Dizziness; Weakness

  MAUDE report 6282455 ↗

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