TRUEbalance TRUEbalance 50 Blood Glucose Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00021292007959), received between Nov 21, 2016 and Jun 7, 2022 — classified as 11 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K090495); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, 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 ↗
• 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 ↗
• 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 29, 2017Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 258 (NON-FASTING) AND 239 (FASTING) MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160 - 175 MG/DL AND HER NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 190 - 200 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2017, SHE HAD OBTAINED A RESULT OF 258 NON-FASTING AND THAT SHE WENT STRAIGHT TO THE ER. CUSTOMER STATED WHEN SHE ARRIVED AT THE ER SHE WAS AT 133 MG/DL NON-FASTING. CUSTOMER DID NOT MENTION IF SHE TOOK MEDICATION BEFORE GOING TO THE HOSPITAL. CUSTOMER DID NOT RECEIVE ANY TREATMENT AND SHE WENT HOME ON THE SAME DAY. 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 11/25/2019 AND OPEN VIAL DATE IS 08/29/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 1:258MG/DL (B)(6) 2017 09:36 AM FASTING:NO. 2:189MG/DL (B)(6) 2017 01:09 PM FASTING:YES. 3:186MG/DL (B)(6) 2017 09:30 AM FASTING:YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6903695 ↗
• MalfunctionMay 31, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 440 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 170 MG/DL. AT THE TIME OF THE CALL ON (B)(6) 2017 THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MOTHER STATED THAT SHE HAD CALLED 9-1-1 DUE TO RESULT OBTAINED ON METER OF 440 MG/DL (FASTING). MOTHER STATED THAT THE CUSTOMER WAS FEELING FINE BUT TO BE SAFE HAD CALLED 9-1-1. MOTHER STATED THAT CUSTOMER HAD GONE TO THE HOSPITAL ON (B)(6) 2017; MOTHER STATED THAT THEY GAVE CUSTOMER FLUIDS AND SENT HER HOME. MOTHER STATED SHE COULD NOT REMEMBER WHAT CUSTOMER'S BLOOD SUGAR WAS AT THE HOSPITAL. 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 10/13/2017 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:CUSTOMER IS CONCERNED WITH 440 MG/DL FASTING RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6601299 ↗
• MalfunctionMay 17, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF "HI". THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 260 TO 300 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER CALL PARAMEDICS AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS ON (B)(6) 2017. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): TRUE METRIX HI (B)(6) 2017 09:23:00 PM NOT FASTING. TRUE METRIX HI (B)(6) 2017 07:47:00 PM NOT FASTING. MEMORY CONCERNS: CUSTOMER IS CONCERNED WITH ALL OF THE READINGS CUSTOMER CALLED IN CONCERNING HI RESULT. CUSTOMER STATES THAT SHE WAS RECENTLY HOSPITALIZED DUE TO A HEART ATTACK AND SINCE HAS HAD HIGH RESULTS. CUSTOMER STATES THAT ON (B)(6) 2017, SHE TOOK HER BLOOD GLUCOSE RESULT AND METER READ HI. CUSTOMER SAYS SHE CALLED FOR A PARAMEDIC AND WHEN THEY TESTED HER GLUCOSE LEVELS ON THEIR EQUIPMENT, METER READ 439 MG/DL (NON-FASTING). CUSTOMER WAS TREATED WITH INSULIN. SHE DID NOT GO BACK

  Patient problems: Hyperglycemia

  MAUDE report 6573493 ↗
• MalfunctionApr 27, 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 197 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 71 - 88 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 125 MG/DL USING TRUEBALANCE METER AND 140 MG/DL USING TRUEBALANCE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/19/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:197MG/DL FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525961 ↗
• MalfunctionJan 31, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 250 TO 350 MG/DL. THE CUSTOMER FEELS REPORTED SYMPTOM OF FEELING TIRED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/27/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MADE A FOLLOW-UP CALL WAS MADE IN AN EFFORT TO ENSURE THE CUSTOMERS NEW REPLACEMENT PRODUCTS IS NOT HI AS PREVIOUSLY STATED BY THE CUSTOMER. I CONTACTED CUSTOMER AND CUSTOMER STATES THAT SHE IS STILL GETTING THE HI RESULT ON THE METER. CUSTOMER STATES THAT SHE KNOWS THAT HER GLUCOSE HAVE BEEN HIGH LATELY., CUSTOMER STATES THAT SHE HAD SPOKEN TO HER DR. A WEEK AGO AND HE CALL HAD PRESCRIBE LANTIS FOR HER AND SHE STARTED TAKING THE LANTIS ON (B)(6) 2016. CUSTOMER STATES THAT SHE IS FEELING TIRED BUT DOES NOT REQUEST ANY MEDICAL ASSISTANCE. CUSTOMER WILL BE FOLLOWING BACK UP WITH THE DOCTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6289412 ↗
• MalfunctionDec 19, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER COMPLAINT OF E-4 ERROR; INTERNAL SAFETY METER MECHANISM ERROR. THE E-4 ERROR OCCURRED AS SOON AS THE TEST STRIP WAS INSERTED IN THE METER. DURING THE CALL ON (B)(6) 2016, THE CUSTOMER STATED SHE WAS FEELING WEAK. THE CUSTOMER DECLINED SEEKING MEDICAL ATTENTION. CUSTOMER WAS ADVISED IF HER SYMPTOMS PERSISTED TO SEEK MEDICAL ATTENTION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/20/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Weakness

  MAUDE report 6186494 ↗
• MalfunctionNov 21, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT VIA EMAIL FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 TO 90MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING LIGHTHEADED, SHAKY AND LOSS OF CONSCIOUSNESS. CUSTOMER REPORTED WAS AT THE HOSPITAL ON (B)(6) 2016 AS A RESULT OF THE HIGH BLOOD GLUCOSE RESULTS AND SYMPTOMS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/29/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): CUSTOMER STATES THAT RAN A BLOOD TEST AND OBTAINED THE BLOOD GLUCOSE RESULT OF 100MG/DL FASTING CUSTOMER TESTED AT THE HOSPITAL AND OBTAINED RESULTS OF 30MG/DL NOT FASTING. THE CUSTOMER TREATED WITH GLUCOSE FLUIDS TO RAISE THE GLUCOSE LEVEL. CUSTOMER STATES WAS IN THE HOSPITAL FOR 3-4 HOURS; CUSTOMER TESTED BEFORE DISCHARGED AND OBTAINED RESULTS OF 85MG/DL AS THE SAME AS WITH THE TRUE BALANCE WITH RESULT OF 120MG/DL. CUSTOMER CONTACTED (B)(4) AND GOT A REPLACEMENT WITH ANOTHER TRUE BALANCE METER. CUSTOMER STATES THAT CONSIDERED PURCHASE ANOTHER METER AT (B)(4) , THE

  Patient problems: Headache; Loss of consciousness; Shaking/Tremors

  MAUDE report 6118798 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090495. One submission often covers many models, so check the product and lot details in each record.

• Z-2883-2016 · 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-0909-2014 · Oct 2, 2013 · Terminated
  MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 3