TRUEbalanceRecalls & reported problems across all models

We found 3 models of TRUEbalance by Trividia Health, Inc. in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2016 and Jun 7, 2022 — classified as 1 injury, 66 malfunctions.

The most frequently reported specific device problem is “High Test Results” (47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TRUEbalance problems

TRUEbalance models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUEbalance TRUEbalance BLOOD GLUCOSE MONITORING SYSTEM

  System, Test, Blood Glucose, Over The Counter
  55 reports
• TRUEbalance TRUEbalance 50 Blood Glucose Test Strips

  Glucose Oxidase, Glucose
  11 reports
• TRUEbalance TRUEbalance 10 Blood Glucose Test Strips

  Glucose Oxidase, Glucose
  1 report

Recent TRUEbalance adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022No Apparent Adverse Event; No Apparent Adverse Event

  CONSUMER CALLED TO INQUIRE ABOUT RETURNING DISCONTINUED PRODUCT; CUSTOMER HAS TRUE BALANCE TEST STRIPS. CUSTOMER HAD NEVER USED THE TEST STRIPS; CUSTOMER DOES NOT HAVE A TRUE BALANCE METER. THE TEST STRIPS ARE EXPIRED - MANUFACTURER'S EXPIRATION DATE IS 08/26/2017 AND TEST STRIPS ARE PART OF RECALL. CUSTOMER DID NOT REPORT A COMPLAINT ASSOCIATED WITH THE PRODUCTS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCTS WAS REPORTED. CUSTOMER ALREADY HAD A TRUE METRIX METER AND WAS SENT A TRUE METRIX VIAL OF TEST STRIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626191 ↗
• MalfunctionMay 13, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR ERROR MESSAGES (E-4 AND E-8). DURING THE CALL, THE TRUE BALANCE METER DISPLAYED HI WHEN THE CUSTOMER INSERTED A TEST STRIP. THE METER MEMORY WAS REVIEWED AND CUSTOMER REPORTED A RESULT OF LO. CUSTOMER STATED THAT SHE DOES NOT TEST REGULARLY AND DID NOT REMEMBER THIS RESULT. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/22/2023 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398235 ↗
• MalfunctionDec 14, 2021Display or Visual Feedback Problem; No Apparent Adverse Event; Display or Visual Feedback Problem; No Apparent Adverse Event

  CONSUMER REPORTED COMPLAINT THAT THE TRUE TRACK METER DOES NOT DISPLAY THE BLINKING BLOOD DROP. CUSTOMER STATED THAT ONLY "CODE" APPEARS IN THE DISPLAY; THE DROP SYMBOL DOES NOT APPEAR IN THE DISPLAY. CUSTOMER IS USING THE INCORRECT TEST STRIPS FOR THE METER; CUSTOMER IS USING TRUE BALANCE TEST STRIPS WITH THE TRUE TRACK METER. THE TEST STRIPS ARE EXPIRED - MANUFACTURER'S EXPIRATION DATE IS 08/26/2017 AND TEST STRIPS ARE PART OF RECALL. CUSTOMER HAS TWO VIALS OF THE SAME LOT NUMBER OF TEST STRIPS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER WAS UPGRADED TO TRUE METRIX PRODUCT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003676 ↗
• MalfunctionJul 24, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 240-490MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING SHAKY, DIZZY AND THIRSTY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/18/2018 (EXPIRED) AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Polydipsia

  MAUDE report 10323566 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR USING EXPIRED STRIPS LEADING TO CONTACTING DOCTOR. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS AT TIME OF CALL. MEDICAL ATTENTION IS REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/13/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9977264 ↗
• MalfunctionMay 20, 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 200 AND 300 MG/DL FASTING. 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/18/2021 AND TEST STRIPS WERE OPENED ONE WEEK AGO. DURING THE TROUBLESHOOTING PROCESS, THE CALL WAS DISCONNECTED; ATTEMPTED TO CALL CUSTOMER BACK BUT WAS UNABLE TO REACH. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8625486 ↗
• MalfunctionMay 17, 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 336 MG/DL FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 125 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT SHE HAD BEEN HOSPITALIZED FOR THREE DAYS ABOUT THREE WEEKS AGO (CUSTOMER DOES NOT REMEMBER THE EXACT DATES). CUSTOMER STATED SHE HAD OBTAINED A RESULT OF 275 MG/DL NON-FASTING. CUSTOMER HAD EATEN AND TAKEN HER INSULIN LIKE USUAL AT 6 PM. CUSTOMER HAD TAKEN 35 UNITS OF INSULIN ACCORDING TO HER SLIDING SCALE. CUSTOMER STATED SHE HAD GONE TO BED AT 10 PM, CUSTOMER'S HUSBAND WOKE UP AT 3 AM AND WHEN HE TRIED TO TALK TO HER SHE WAS UNCONSCIOUS. THE HUSBAND AND DAUGHTER CALLED 911. THE PARAMEDICS ARRIVED AND THE CUSTOMER'S BLOOD SUGAR TEST RESULT WITH THEIR METER WAS 40 MG/DL. CUSTOMER WAS TREATED BY THE PARAMEDICS AND STATED SHE WAS GIVEN AN INJECTION TO RAISE HER BLOOD GLUCOSE. CUSTOMER STATED SHE WAS TAKEN TO THE HOSPITAL. CUSTOMER STATED SHE WAS CONSCIOUS WHEN SHE ARRIVED AT THE HOSPITAL AND HER BLOOD GLUCOSE TEST RESULT WITH THE HOSPITAL'S METER WAS 2

  Patient problems: Hyperglycemia; Loss of consciousness

  MAUDE report 8622012 ↗
• MalfunctionMay 2, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE DIRECTOR OF NURSING IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 275 AND 128MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. 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 REVIEWED FOR PREVIOUS TEST RESULT HISTORY BY QC. RESULT 1: (B)(6) 2019 3:08:00 PM 275 POST LUNCH BLOOD. RESULT 2: (B)(6) 2019 3:09:00 PM 128 POST LUNCH BLOOD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575027 ↗
• MalfunctionApr 25, 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 406 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 211 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 A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 329 MG/DL. THE CUSTOMER DECLINED TO PERFORM A SECOND BLOOD TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2020 AND OPEN VIAL DATE IS 03/18/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8553132 ↗
• MalfunctionJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR TEST STRIP NO RECOGNIZING OR TEST STRIP NOT ABSORBING THE BLOOD. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER WAS USING THE INCORRECT TEST STRIPS - LOT MV2866 IS A TRUEMETRIX TEST STRIP LOT NUMBER AND NOT FOR USE WITH TRUEBALANCE METER. CUSTOMER WAS ADVISED TO PURCHASE THE CORRECT PRODUCT. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING PHYSICALLY ILL WITH INCREASED URINATION. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL.

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 8248589 ↗
• MalfunctionOct 10, 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 172, 175, 183, 178, 164 MG/DL. CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 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 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 04/30/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :172MG/DL DATE: (B)(6) 2018 TIME:08:52AM FASTING ; RESULT 2 :175MG/DL DATE: (B)(6) 2018 TIME:08:15 AM FASTING ; RESULT 3 :183MG/DL DATE: (B)(6) 2018 TIME:08:12AM FASTING; RESULT 4 :178MG/DL DATE: (B)(6) 2018 TIME:10:28AM FASTING; RESULT 5 :164MG/DL DATE: (B)(6) 2018 TIME:08:20AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7953280 ↗
• MalfunctionSep 14, 2018Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 57 MG/DL. THE CUSTOMER ALSO REPORTED COMPLAINT FOR HIGH CONTROL GLUCOSE TEST RESULT. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 105 - 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 326 MG/DL AND 294 MG/DL USING TRUEBALANCE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/21/2020 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: RESULT 1 :57MG/DL DATE: (B)(6) 2018 TIME:08:43AM FASTING; RESULT 2 :110MG/DL DATE: (B)(6) 2018 TIME:11:34AM FASTING; RESULT 3 :105MG/DL DATE: (B)(6) 2018 TIME:11:32AM FASTING; RESULT 4 :137MG/DL DATE: (B)(6) 2018 TIME:11:33AM FASTING; RESULT 5 :158MG/DL DATE: (B)(6) 2018 TIME:12:21PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878147 ↗
• MalfunctionSep 12, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 208 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 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 05/21/2020 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 7868446 ↗
• MalfunctionAug 2, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 252 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 135 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 330 MG/DL AND 342 MG/DL USING TRUEBALANCE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/21/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :236MG/DL DATE: (B)(6) 2018 TIME:1:00PM FASTING; RESULT 2 :252MG/DL DATE: (B)(6) 2018 TIME:12:58PM FASTING; RESULT 3 :203MG/DL DATE: (B)(6) 2018 TIME:10:04AM FASTING; RESULT 4 :189MG/DL DATE: (B)(6) 2018 TIME:8:58AM FASTING; RESULT 5 :167MG/DL DATE: (B)(6) 2018 TIME:9:54AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742685 ↗
• MalfunctionJun 11, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 45, 189 AND 232 MG/DL. CUSTOMER IS ALSO CONCERNED WITH BACK TO BACK BLOOD TEST RESULTS OF 453 AND 446 MG/DL PERFORMED DURING THE CALL ON (B)(6) 2018 USING TRUEBALANCE METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 81 - 90 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 IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2020 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 7588885 ↗

Other Trividia Health, Inc. products

• TRUE METRIX31 models · 4,546 reports · 2 recalls
• TRUE METRIX AIR16 models · 693 reports · 1 recall
• TRUEtrack21 models · 445 reports
• TRUEplus37 models · 269 reports
• TRUE METRIX PRO5 models · 23 reports · 1 recall
• TRUE METRIX GO3 models · 2 reports · 1 recall
• TRUE FOCUS2 models · 48 reports