TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER (REF RE4027-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00021292007065), received between Dec 9, 2016 and Jan 24, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2019High 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 92, 140, 143 AND 177 MG/DL. CUSTOMER ALSO STATED THAT ON 12/9/2018 SHE HAD PERFORMED A BLOOD GLUCOSE TEST FASTING AND OBTAINED A RESULT OF 445 MG/DL. CUSTOMER STATED THAT SHE TOOK HER METFORMIN SHORTLY THEREAFTER. THE HOME NURSE ARRIVED 30 MINUTES LATER, AND CUSTOMER EXPLAINED WHAT HAD HAPPENED. HOME NURSE WAITED AN HOUR AFTER, AND THEN CHECKED THE CUSTOMER'S BLOOD SUGAR AGAIN. CUSTOMER STATED THAT THE RESULT WAS 421 MG/DL NON-FASTING. HOME NURSE CALLED THE PARAMEDICS WHO HAD ARRIVED 30 MINUTES LATER. CUSTOMER'S BLOOD SUGAR TEST RESULT WHEN TESTED USING THE PARAMEDICS METER WAS 114 MG/DL NON-FASTING. THE RESULTS OF 445 AND 421 MG/DL COULD NOT BE CONFIRMED IN THE METER MEMORY. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 90 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. DURING THE CALL ON 12/28/2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 1020/2019 A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273879 ↗
• MalfunctionJan 23, 2019High Test Results; Adverse Event Without Identified Device or Use Problem; High Test Results; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED IN THE 140'S MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM PASSING OUT AFTER TAKING INSULIN BASED ON HIGH RESULT OBTAINED. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOM (PASSING OUT). THE PRODUCT STORAGE LOCATION IS UNDISCLOSED THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER IS CONCERNED THAT METER IS READING TOO HIGH. CUSTOMER SAYS THAT AT AN EARLIER TIME (DATE NOT SPECIFIED), HE TESTED ON HIS TRUE METRIX AND RESULTS READ IN THE 140'S (EXACT NUMBER NOT SPECIFIED). CUSTOMER SAYS HE TOOK 1 UNIT OF NOVOLOG AND THEN WENT FOR A WALK. CUSTOMER SAYS WHILE OUT FOR HIS WALK, HE FAINTED, AND A NEIGHBOR CALLED FOR HELP AND HE WAS TRANSPORTED TO THE ER. CUSTOMER SAYS AT THE ER, HE WAS TESTED, AND RESULT READ IN THE LOW 40'S (EXACT RESULT NOT SPECIFIED). CUSTOMER WAS UPSET AND REFUSED TO TROUBLESHOOT OR PROVIDE NECESSARY INFO

  Patient problems: Fainting

  MAUDE report 8271773 ↗
• MalfunctionMar 26, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 281 AND 205 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 - 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 127 MG/DL AND 131 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/21/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :191MG/DL DATE: (B)(6) 2018 TIME:03:20PM FASTING; RESULT 2 :281MG/DL DATE: (B)(6) 2018 TIME:03:17PM FASTING; RESULT 3 :155MG/DL DATE: (B)(6) 2018 TIME:03:15PM FASTING; RESULT 4 :131MG/DL DATE: (B)(6) 2018 TIME:09:35AM FASTING; RESULT 5 :205MG/DL DATE: (B)(6) 2018 TIME:07:38AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7369599 ↗
• MalfunctionMar 20, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. FATHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 207, 205, 196, 222 AND 215 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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 NOT PERFORMED BY THE CUSTOMER; THE METER WOULD NOT TURN ON. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (METER WOULD NOT TURN ON; CUSTOMER PROVIDED WRITTEN RESULTS): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7355144 ↗
• MalfunctionMar 16, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. 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 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 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CALL RECEIVED BY PHARMACIST AND STATES METER WAS READING LO DISPLAY. PHARMACIST TESTES WITH THE METER AND OBTAINED 20 MG/DL. DAUGHTER WAS ON THE PHONE BRIEFLY AND STATES SHE HAD 3 DEATHS IN THE FAMILY AND DOESN'T HAVE THE PATIENCE. PHARMACIST OPENED A NEW VIAL AND OBTAINED 103 MG/DL NON-FASTING. ASKED DAUGHTER ABOUT REPLACING THE SYSTEM AND SHE STATES SHE NEEDS TO GET HOME TO HER MOTHER TO MAKE SURE SHE IS OK. I ADVISED DAUGHTER OF PROPER STORAGE TECHNIQUE. DAUGHTER STATES SHE WILL HAVE TO CALL BACK ANOTHER TIME WHEN SHE IS HOME, S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7344951 ↗
• MalfunctionJan 22, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH METER TO METER COMPARISON RESULTS OF 303 MG/DL USING TRUE METRIX AND 248 MG/DL USING DOCTOR'S METER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY, HEADACHE, INCREASE 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 IN THE OFFICE. 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 11/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1 :303 MG/DL (B)(6) 2017 11:30 AM FASTING (FROM LOG BOOK) NOTIFIED CUSTOMER TO PLEASE CONTACT HEALTHCARE PROVIDER DUE TO SYMPTOMS OF HYPERGLYCEMIA. CUSTOMER BECAME VULGAR AND DISCONNECTED CALL. COULD NOT OBTAIN HISTORY OF METER DUE TO CALL BEING DISCONNECTED AND UNABLE TO SHIP REPLACEMENT PRODUCTS. ON FOLLOW UP ATTEMPT, CUSTOMER REFUSED TO ANSWER ANY QUESTIONS.

  Patient problems: Dizziness; Headache; Urinary Frequency / Polyuria

  MAUDE report 7210250 ↗
• MalfunctionNov 8, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. GRANDDAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 516, 431, 338, 355 AND 477 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 200 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF DRY MOUTH, INCREASED THIRST AND FREQUENT URINATION. CUSTOMER DECLINED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 533 MG/DL AND 523 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/26/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 516 MG/DL DATE: (B)(6) 2017 TIME: 3:44PM FASTING; RESULT 2 : 431MG/DL DATE: (B)(6) 2017TIME: 12:14PM FASTING; RESULT 3 : 338MG/DL DATE: (B)(6) 2017TIME: 12:26PM FASTING ; RESULT 4 : 355MG/DL DATE: (B)(6) 2017TIME: 3:34PM FASTING; RESULT 5 : 477MG/DL DATE: (B)(6) 2017 TIME: 2:18PM

  Patient problems: No Code Available; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7010197 ↗
• MalfunctionJul 5, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 859 TO 95MG/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 NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 164MG/DL (B)(6) 2017 01:28 PM FASTING: YES; 139MG/DL (B)(6) 2017 12:00 PM FASTING: YES; 125MG/DL (B)(6) 2017 12:00 PM FASTING: YES; 110MG/DL (B)(6) 2017 10:00 AM FASTING: YES; 113MG/DL (B)(6) 2017 12:00 AM FASTING: YES. CUSTOMER IS CONCERNED WITH HIGH READINGS. RESULTS OF CONCERN IS 110, 113, 125, 139, 164MG/DL FASTING. EXPECTED FASTING RAND IS 89-95MG/DL. CUSTOMER DENIES HAVING SIGNS AND SYMPTOMS OF HYPERGLYCEMIA. CUSTOMER DENIES NEED FOR MEDICAL ATTENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685902 ↗
• MalfunctionJun 19, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULTS OBTAINED OF 65MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160 TO 170MG/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 NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE CAR. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/21/2018 AND OPEN VIAL DATE IS 05/23/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 69MG/DL (B)(6) 2017 09:30 AM FASTING: YES, THE 65MG/DL (B)(6) 2017 01:21 PM FASTING: YES, THE 85MG/DL (B)(6) 2017 10:00 AM FASTING: YES, THE 138MG/DL (B)(6) 2017 08:00 AM FASTING: YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6650026 ↗
• MalfunctionJan 23, 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 107MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. 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 NON- FASTING AND PRODUCED TEST RESULTS OF 276 AND 287MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/25/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CUSTOMER STATES THAT HE COMPARES IT TO THE LAB TEST AND IT WAS 54MG/DL DIFFERENCE. CUSTOMER STATES THAT HIS NORMAL GLUCOSE RANGE IS 107MG/DL AND HE ONLY TEST ONCE A DAY AND IS NOT TAKING ANY MEDICATION FOR DIABETES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6271725 ↗
• MalfunctionDec 13, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 237, 175 AND 245 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 93 - 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 140 MG/DL USING TRUEMETRIX METER AND 146 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 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 6170168 ↗
• MalfunctionDec 9, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 235 AND 343 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 180 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 235 MG/DL AND 222 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/21/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 1:135MG/DL (B)(6) 2016 04:29 PM FASTING:YES; 2:121MG/DL (B)(6) 2016 10:30 AM FASTING:YES; 3:99MG/DL (B)(6) 2016 10:01 AM FASTING:YES; 4:366MG/DL (B)(6) 2016 10:51 PM FASTING:YES; 5:140MG/DL (B)(6) 2016 10:07 AM FASTING:YES; MEMORY CONCERNS:366MG/DL. CUSTOMER HAS NOT HAD ANY RECENT CHANGES IN THE DIET, EXERCISE, OR MEDICATIONS. ADDITIONAL,CUSTOMER IS CONCERNED WITH THE READING OF 343MG/DL FASTING OBTAINED ON 11/11/2016 AT 10:43 PM. ALSO WITH READING OF 235

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6158467 ↗