TRUEtrack TRUEtrack blood glucose monitorRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00011822577540), received between Nov 22, 2016 and Sep 14, 2018 — classified as 34 malfunctions.

The most frequently reported specific device problem is “High Test Results” (22 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR CODE; USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE E-3 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. PRIOR TO CALL BEING TRANSFERRED, A BLOOD TEST HAD BEEN PERFORMED BY CUSTOMER AND PRODUCED TEST RESULT OF 441 MG/DL USING TRUETRACK METER; CUSTOMER STATED SHE WAS NOT CONCERNED WITH THE RESULT. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT DISCLOSED. AT THE TIME OF THE CALL, THE CUSTOMER STATED THAT SHE WAS FEELING FUNNY AND SHAKY. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2020 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER HAD DISCONNECTED THE CALL DURING THE TROUBLESHOOTING PROCESS.

  Patient problems: Shaking/Tremors

  MAUDE report 7878363 ↗
• MalfunctionAug 2, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018 THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. BACK TO BACK BLOOD TEST WAS NOT PERFORMED DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING AREA. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/21/2019 AND OPEN VIAL DATE WAS ONE WEEK. ADVERSE EVENT NOT REPORTED AT TIME OF CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7743793 ↗
• MalfunctionJul 24, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 227, 382, 300 AND 489MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 TO 120MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/23/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:227MG/DL DATE: (B)(6) 2017 TIME:12:04A N/FASTING; RESULT 2:382MG/DL DATE: (B)(6) 2017 TIME:12:00A N/ FASTING; RESULT 3:300MG/DL DATE: (B)(6) 2017 TIME:7:05A N/FASTING; RESULT 4:489MG/DL DATE: (B)(6) 2017 TIME:6:18P N/FASTING; RESULT 5:166MG/DL DATE: (B)(6) 2017 TIME:6:41P N/FASTING; STRIPS WERE EXPOSED TO EXTREME HEAT FOR 3 HOURS ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715345 ↗
• MalfunctionMay 1, 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 169, 358, 340, 283 AND 319 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 145 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 ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/27/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES HER METER READ ABOVE 280 MG/DL FASTING AND IS NOT READING ACCURATELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7477364 ↗
• MalfunctionApr 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 393 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 110 MG/DL; A NON-FASTING EXPECTED TEST RESULT RANGE WAS NOT PROVIDED. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT A FEW DAYS AGO SHE HAD NOT BEEN FEELING WELL, CUSTOMER DID NOT SAY WHAT THE SYMPTOMS WERE. CUSTOMER HAD CALLED HER DOCTOR AND WENT TO HAVE HER BLOOD TESTED. CUSTOMER'S BLOOD TEST RESULT WHILE AT THE DOCTOR'S OFFICE WAS 240 MG/DL FASTING. CUSTOMER DID NOT DISCLOSE IF ANY TREATMENT WAS RECEIVED. CUSTOMER LEFT THE DOCTOR'S OFFICE THE SAME DAY, NO NEW MEDICATIONS OR HEALTHCARE PROGRAM WAS SUGGESTED. 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; CUSTOMER KEEPS IN HER PURSE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS ONE MONTH. CUSTOMER WAS NOT ABLE TO GO THROUGH THE METER MEMORY. RESULT 1:108MG/DL (B)(6) 2:20PM 2 OR MORE HOURS AFTER EATING; RESULT 2:

  Patient problems: No Information

  MAUDE report 7456498 ↗
• MalfunctionApr 4, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER COMPLAINT OF E-3 ERROR; TEST STRIP ERROR. E-3 ERROR OCCURRED UPON INSERTION OF TEST STRIP INTO METER PORT. 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. BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2018 PRODUCED RESULT OF E-3 UPON INSERTION OF TEST STRIP INTO METER PORT. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/20/2019 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397860 ↗
• MalfunctionApr 3, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 574 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF SLURRED SPEECH. 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 BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 574 MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED IN FOR ASSISTANCE RUNNING A BLOOD TEST. CUSTOMER REPORTED SYMPTOMS OF SLURRED SPEECH. UPON BLOOD TEST CUSTOMER READ READING OF 574 MG/DL FASTING. CUSTOMER WAS NOT ABLE TO CONTINUE THE CALL.

  Patient problems: Hyperglycemia; No Code Available

  MAUDE report 7391971 ↗
• MalfunctionApr 2, 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 125 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 DINING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 177 AND 175 MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 4/13/2020 AND OPEN VIAL DATE (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 7388400 ↗
• MalfunctionFeb 16, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH METER TO METER COMPARISON OF 117MG/DL USING THE TRUE TRACK AND 160MGDL USING THE DOCTOR'S METER AND THE RESULTS OBTAINED OF 105MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-160MG/DL. THE CUSTOMER FEELS WELL AND DID REPORT SYMPTOMS ON DEC 14, 2017 OF SLURRED SPEECH. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. 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 06/30/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:117MG/DL DATE:(B)(6) 2018 TIME:11:15AM N/FASTING RESULT 2:105MG/DL DATE:(B)(6) 2018 TIME:9:20AM FASTING RESULT 3:308MG/DL DATE:(B)(6) 2018 TIME:11:43PM FASTING RESULT 4:280MG/DL DATE:(B)(6) 2018 TIME:10:00PM FASTING RESULT 5:298MG/DL DATE:(B)(6) 2018 TIME:3:11PM N/FASTING CUSTOMER CALLED IN STATING THAT ON (B)(6) 2017 WHILE HAVING DINNER WITH A FRIEND, HE STARTED HA

  Patient problems: No Code Available

  MAUDE report 7277071 ↗
• MalfunctionFeb 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC AND LOW BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 83, 94 AND 206 MG/DL. THE EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 130 MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF BLURRY VISION AND TINGLING IN HANDS. 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/16/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER RAN A BLOOD TEST AND THE RESULTS ARE LOW AND ERRATIC. CUSTOMER IS CONCERN BECAUSE HER RESULTS ARE LOW AFTER EATING. CUSTOMER STATES THAT SHE NORMAL TAKE HER BLOOD SUGAR IS 120-130 MG/DL NON- FASTING AND SHE NORMALLY RUNS HER TEST 45 MINS TO 1 HOUR AND A HALF AFTER EATING. CUSTOMER RESULTS ARE NOT FASTING. CUSTOMER RAN SEVERAL BLOOD TESTS 200 MG/DL NON-FASTING THEN ANOTHER BLOOD TEST GOT 100/170 MG/DL. CUSTOMER TESTED 10 TIMES IN A ROW AND GOT VARYING RESULTS. CUSTOMER HAVE GESTATIONAL DIABETES AND SHE IS NOT TAKING ANY MEDICATIO

  Patient problems: Blurred Vision; Tingling

  MAUDE report 7247865 ↗
• MalfunctionFeb 5, 2018High Test Results; High Test Results

  CONSUMER INITIALLY 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 HAD OCCURRED ONCE THE TEST STRIP WAS INSERTED INTO THE METER. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF HI AND HI USING TRUETRACK METER. THE CUSTOMER DID NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. 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 HAD JUST PURCHASED THE TEST STRIPS ON DAY OF CALL; CUSTOMER WAS INFORMED OF PROPER STORAGE LOCATIONS.THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 4/13/2020 AND OPEN VIAL DATE IS (B)(6) 2018. CUSTOMER WAS ONLY ABLE TO OBTAIN TWO RESULTS FROM THE METER MEMORY: RESULT 1 : HI MG/DL DATE: (B)(6) 2018 TIME:07:09 PM FASTING, RESULT 2 : HI MG/DL DATE: (B)(6) 2018 TIME:07:09PM FASTING. CUSTOMER CALLED IN STATES THE METER IS READING E-3 WHILE CONDUCTING TROUBLESHOOTING CUSTOMER RECEIVED AN HI DISPLAY.CUSTOMER STATES THE METER READ HI FASTING AND ANOTHER HI FASTING WITHIN 15 MINUTES OF EACH OTHER.CUST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7242176 ↗
• MalfunctionFeb 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. CUSTOMER'S WIFE IS CALLING ON HIS BEHALF. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 169,197,171 AND 208 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-130 MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING WEAK. 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 LIVING 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 04/26/2020 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT HE FEELS WEAK AND DOES NOT KNOW IF THAT IS RELATED TO HIS BLOOD SUGAR. CUSTOMER STATES THAT HE HAS BEEN A DIABETIC FOR A LONG TIME AND KNOWS THAT HIS RESULTS SHOULD NOT BE HIGHER THAN 140 MG/DL FASTING. CUSTOMER IS CONCERNED THAT THE METER IS GIVING HIGH RESULTS WHEN THERE HAVE BEEN NO CHANGES TO HIS ROUTINE.

  Patient problems: Weakness

  MAUDE report 7234192 ↗
• MalfunctionJan 15, 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 148, 155, 210 AND 144 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER WAS NOT FASTING AT TIME OF CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/27/2020 AND OPEN VIAL DATE IS 12/19/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7188993 ↗
• MalfunctionJan 2, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 100 AND 151MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 96MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING SHAKY. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN HER POCKETBOOK. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 5/31/2019 AND OPEN VIAL DATE IS A LITTLE OVER A WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). RESULT 1 :167MG/DL DATE: (B)(6) TIME:1:42PM FASTING. RESULT 2 :127MG/DL DATE: (B)(6) TIME:4:52PM FASTING. RESULT 3 :100MG/DL DATE: (B)(6) TIME:4:30PM FASTING. RESULT 4 :151MG/DL DATE: (B)(6) TIME:4:15PM FASTING. RESULT 5 :117MG/DL DATE: (B)(6) TIME:4:00PM FASTING. CUSTOMER STATES THAT THE METER IS GIVING HER ERRATIC RESULTS. CUSTOMER IS FEELING A LITTLE SHAKY AT THIS TIME. CUSTOMER ALSO STATED THAT SHE WAS FEELING SHAKY ON (B)(6) 2017 AND WENT TO THE HOSPITAL. CUSTOMER STATED THAT WHEN SHE WENT TO THE ER HER BLOOD GLUCOSE W

  Patient problems: Shaking/Tremors

  MAUDE report 7157070 ↗
• MalfunctionNov 21, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DURING THE CALL ON (B)(6) 2017 THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2017 AS A RESULT OF THE METER'S READINGS. 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 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2017. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7050217 ↗
• MalfunctionNov 20, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON OF 205 MG/DL FASTING USING TRUETRACK METER AND 112 MG/DL FASTING USING TRUERESULT METER. THE CUSTOMER IS ALSO CONCERNED THAT RESULTS OBTAINED OF 205, 315 AND 195 MG/DL ARE TOO HIGH. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 - 140 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF TRUERESULT AND UPGRADE WAS SENT, REFERENCE INTERNAL REPORT (B)(4). 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 IN A CABINET IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/26/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT1: 205MG/DL DATE: (B)(6) 2017 TIME:9:52AM FASTING. RESULT2: 137MG/DL DATE: (B)(6) 2017 TIME:7:22AM FASTING. RESULT3 : 129MG/DL DATE: (B)(6) 2017 TIME:7:19AM FASTING. RESULT4 : 315MG/DL DAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7045002 ↗
• MalfunctionNov 10, 2017High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER COMPLAINT OF E-3 ERROR CODE. E-3 ERROR OCCURRED UPON INSERTION OF TEST STRIP INTO METER PORT AND AFTER BLOOD SAMPLE APPLIED TO THE TEST STRIP. AT THE TIME OF THE CALL CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED CURRENTLY AS A RESULT OF BLOOD GLUCOSE RESULTS.THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 295MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. THE CUSTOMER DID REPORT SYMPTOMS ON (B)(6) 2017 AND MEDICAL ATTENTION WAS REPORTED AS A RESULT OF THE BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS ON THAT DAY. CUSTOMER STATES HE HAD KETOACIDOSIS AND WAS ADMITTED TO THE HOSPITAL WITH A BLOOD GLUCOSE READING OF 519MG/DL. HE STATES HE WAS VOMITING, WAS IN AND OUT OF CONSCIOUSNESS AND DOES NOT REMEMBER THE DETAILS. HE WAS TREATED WITH IV MEDICATION. THE CUSTOMER WAS GIVEN NEW MEDICATIONS. TWO NEW INSULINS, BLOOD P

  Patient problems: Loss of consciousness; Vomiting

  MAUDE report 7022526 ↗
• MalfunctionOct 24, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 130MG/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 DINING ROOM. DURING THE TIME OF THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (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 6974502 ↗
• MalfunctionOct 12, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER.THE CUSTOMER IS CONCERNED WITH THE RESULT OF 77MG/DL COMPARED TO THE PARAMEDIC RESULT OF 22MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 79-112MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF BEING UNRESPONSIVE. 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE APPROXIMATELY THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY): 1:93MG/DL (B)(6) 2017 PM FASTING: NO. 2:266MG/DL (B)(6) 2017 PM FASTING: NO. 3:164MG/DL (B)(6) 2017 PM FASTING: NO. 4:253MG/DL (B)(6) 2017 PM FASTING: NO. 5:77MG/DL (B)(6) 2017 AM FASTING: YES. BECAUSE OF THE SYMPTOMS OF HER MOTHER BEING VERY LISTLESS AND THEN UNRESPONSIVE THE PARAMEDICS WERE CALLED. THE PARAMEDICS RAN A BLOOD IMMEDIATELY AND THE RESULTS WERE 22MG/DL THEN ON THE TRUE TRACK METER 77MG/DL. PARAMEDICS GAVE HER AN IV AND THE DR. WAS CALLED. MOTHER IS AT H

  Patient problems: Loss of consciousness

  MAUDE report 6945561 ↗
• MalfunctionOct 6, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS . THE CUSTOMER IS CONCERNED WITH THE RESULT OF 374MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING SWEATY, SHAKY AND WEAK. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS.. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6)2019 AND OPEN VIAL DATE IS APPROXIMATELY 20 DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 120MG/DL (B)(6)2017 07:33 AM FASTING: YES. A 187MG/DL (B)(6)2017 09:41 PM FASTING: YES. A 144MG/DL (B)(6)2017 02:51 PM FASTING: YES. A 128MG/DL (B)(6)2017 08:59 AM FASTING: YES. A 169MG/DL (B)(6)2017 10:47 PM FASTING: YES. MEMORY CONCERNS: CUSTOMER IS CONCERN WITH THE RESULTS TAKEN ON (B)(6) 2017 BECAUSE THE RESULTS WERE HIGH AND HE WAS HAVING SYMPTOMS OF LOW BLOOD SUGAR. CALLING CUSTOMER BACK. CUSTOMER STATES THAT HE IS HAVING MANY PROBLEMS WITH THE METER. CUSTOMER STATES THAT HE WOULD WAKE UP WITH HIS SUGAR BEEN LOW, HAVING SYMPTOMS OF SWEAT, S

  Patient problems: Shaking/Tremors; Sweating; Weakness

  MAUDE report 6922137 ↗
• MalfunctionOct 3, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 68, 64 AND 63 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 130 MG/DL. CUSTOMER STATED THAT SHE WAS NOT HAVING ANY SYMPTOMS WHEN SHE GOT THE LOW RESULTS. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. DAUGHTER STATED SHE HAD CALLED THE DOCTOR'S OFFICE TO GET ADVICE AS TO WHY THE RESULTS WERE LOW; DAUGHTER SCHEDULED AN APPOINTMENT FOR CUSTOMER TO GO IN TO SEE THE DOCTOR BECAUSE OF THE LOW RESULTS. CUSTOMER WENT TO THE DOCTOR'S OFFICE ON (B)(6) 2017. CUSTOMER TOOK THE TRUETRACK METER TO THE DOCTOR TO COMPARE AND IS GETTING ABOUT 40 MG/DL DIFFERENCE (COMPARISON RESULTS WERE NOT PROVIDED). WHILE AT THE DOCTOR'S OFFICE, THE DOCTOR PERFORMED A BLOOD TEST AND OBTAINED A RESULT OF 128 MG/DL FASTING AND THEN PERFORMED AN A1C TEST AND THE RESULT WAS 7.5. NO NEW MEDICATIONS WERE PRESCRIBED BY THE DOCTOR. THE DOCTOR ADVISED THE CUSTOMER THAT HER GLUCOSE IS NOT LOW. CUSTOMER PURCHASED ANOTHER TRUETRACK METER AT THE PHARMACY. DURING THE CALL ON (B)(6)201

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6912097 ↗
• MalfunctionAug 10, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. CUSTOMER TESTED BACK TO BACK BECAUSE FIRST RESULT WAS HIGHER THAN EXPECTED. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 161 AND 107 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 105 MG/DL. CUSTOMER IS NOT USING CORRECT TECHNIQUE. CUSTOMER DID MENTION NOT WASHING HANDS BEFORE TESTING. 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 86 MG/DL AND 89 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED CONCERNED OF ERRATIC RESULTS. CUSTOMER TESTED BACK TO BACK BECAUSE FIRST RESULT WAS HIGHER THAN EXPECTED. CUSTOMER RECEIVED RESULTS WITH A 54 POINT VARIANCE. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST AND SAYS HE WILL KE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6784361 ↗
• MalfunctionJul 13, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR CODE ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF BLURRY VISION AND FREQUENT URINATION 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. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 483MG/DL USING TRUE TRACK METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/28/2019 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER COMPLAINING FOR E-5 MESSAGE WHEN BLOOD IS ABSORBED. CUSTOMER REPORTS SYMPTOMS OF BLURRY VISION AND FREQUENT URINATION. AFTER TROUBLESHOOTING CUSTOMER WAS ABLE TO OBTAIN A BLOOD GLUCOSE RESULT.

  Patient problems: Blurred Vision; Urinary Frequency / Polyuria

  MAUDE report 6711858 ↗
• MalfunctionJun 26, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 99 AND 118 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 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. 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 143 MG/DL AND 156 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/23/2019 AND OPEN VIAL DATE IS (B)(6)2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 99MG/DL, (B)(6)2017 07:16 AM, FASTING: YES. A 137MG/DL, (B)(6)2017 02:25 PM, FASTING: YES. A 140MG/DL, (B)(6)2017 07:12 PM, FASTING: YES. A 118MG/DL, (B)(6)2017 07:08 AM, FASTING: YES. A 133MG/DL, (B)(6)2017 08:43 PM, FASTING: YES. MEMORY CONCERNS: CUSTOMER STATES THAT ALL THESE RESULTS ARE TOO LOW FOR HIM CUSTOMER STATES THAT THE METER IS GIVING LOWER RESULTS. CUSTOMER STATES THAT HE IS COMPARING THE RESULTS TO THE METER THAT HIS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6668586 ↗
• MalfunctionJun 9, 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 213 AND 194 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 105 - 128 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 317 MG/DL AND 350 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/29/2018 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER WAS ONLY ABLE TO PROVIDE TWO RESULTS AS HE STATED THAT IT IS TOO MUCH FOR HIM TO DO; CUSTOMER WAS NOT ABLE TO PROVIDE THE DATE THAT WAS DISPLAYED IN THE METER FOR THE RESULTS): A 213MG/DL N/A 03:08 PM FASTING:YES. A 194MG/DL N/A 01:46 PM FASTING:YES. MEMORY CONCERNS:CUSTOMER IS CONCERNED WITH THE RESULTS OF 213 MG/DL AND 194 MG/DL IN THE METERS MEMORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6629739 ↗

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