TRUEbalance TRUEbalance BLOOD GLUCOSE MONITORING SYSTEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00021292003135), received between Dec 2, 2016 and May 13, 2022 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “High Test Results” (40 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. 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 55 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• MalfunctionMay 10, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. MANAGER OF THE GROUP HOME IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 376 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 140 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 MEDICATION DRAWER. 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 01/31/2020 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).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503294 ↗
• MalfunctionMay 3, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY BLOOD GLUCOSE RESULTS. 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 IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 88MG/DL USING TRUE BALANCE METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/15/2019 AND OPEN VIAL DATE IS UNDSCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Shaking/Tremors

  MAUDE report 7484006 ↗
• MalfunctionMar 8, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-188 MG/DL AND 117-250 MG/DL NON- FASTING. THE CUSTOMER DID REPORT SYMPTOMS OF ALTERED MENTAL STATUS, CONFUSION. 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/13/2018 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). NURSE STATES THAT TODAY (B)(6) 2018 SHE CHECKED THE CUSTOMER'S BLOOD SUGAR AND THE RESULTS WERE 460 MG/DL NON-FASTING. CUSTOMER WAS CONFUSED AND DID NOT RECOGNIZED HIS SURROUNDINGS. NURSE CONTACTED THE CUSTOMER'S SON WHO ADVISED NURSE TO TAKE PATIENTS TO THE HOSPITAL. CUSTOMER ARRIVED TO THE HOSPITAL 45 MINUTES LATER AND HIS BLOOD SUGAR WAS 230 MG/DL NON- FASTING WITH THEIR METER. NURSE SATES THAT SHE DID NOT ADMINISTER ANY MEDICATION PRIOR TO GOING TO TH

  Patient problems: Confusion/ Disorientation

  MAUDE report 7325168 ↗
• MalfunctionMar 6, 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 130 TO 150 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 BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 436 AND 384 MG/DL USING TRUE BALANCE METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2020 AND OPEN VIAL DATE IS (DATE). 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 7318517 ↗
• MalfunctionFeb 26, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  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 WAS NOT PERFORMED FASTING DURING CALL. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/20/2018 AND OPEN VIAL DATE IS (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7296364 ↗
• MalfunctionJan 26, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR; CUSTOMER ALSO STATED THE METER READ HI. CUSTOMER WAS MORE CONCERNED THAT THE METER READ E-3 THAN HI. THE CUSTOMER STATED THAT SHE DOES NOT HAVE AN EXPECTED BLOOD GLUCOSE TEST RESULT RANGE; CUSTOMER STATED SHE USUALLY TESTS HI OR IN THE 500S MG/DL. AT THE END OF THE CALL ON (B)(6) 2018, THE CUSTOMER STATED SHE WAS GOING TO SEEK MEDICAL INTERVENTION DUE TO SYMPTOMS OF INCREASED THIRST, INCREASED URINATION AND BLURRY VISION. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE CUSTOMER ALSO STATED SHE HAD POURED THE TEST STRIPS OUT OF THE CONTAINER INTO A PLASTIC BAG. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/22/2020 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER USING A NEW VIAL OF TEST STRIPS WITH THE SAME LOT NUMBER AND PRODUCED TEST RESULT OF HI USING TRUEBALANCE METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : HI MG/DL DATE: (B)(6) 2018 TIME10:57AM FASTING. RESULT 2 : HI MG/DL DATE: (B)(6) 2018 TIME:4:28PM FASTING. RESULT 3 : HI MG/DL DATE: (B)(6) 2017 TIME:11:57AM FASTING. RESULT 4

  Patient problems: Blurred Vision; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7223047 ↗
• MalfunctionJan 16, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. DAUGHTER DID NOT KNOW THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. WHEN INFORMED WHAT HI MEANT, DAUGHTER STATED CUSTOMER'S BLOOD GLUCOSE RESULT MORNING OF CALL WAS 63 MG/DL AND THAT CUSTOMER DID NOT TAKE HER INSULIN AT ALL THAT DAY. DAUGHTER WAS NOT WILLING TO REVIEW THE METER MEMORY. DAUGHTER, WHO IS A PHARMACIST, STATED SHE WAS GOING TO GIVE CUSTOMER INSULIN AND THEN RETEST IN A WHILE. 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 THE DINING AREA. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/23/2019 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7196715 ↗
• MalfunctionJan 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. CUSTOMER STATED THAT SHE GETS EXTREMELY HIGH AND LOW RESULTS, SHE IS NOT CONCERNED AND THAT HER DOCTOR IS AWARE OF THE HIGH RESULTS SHE HAS BEEN GETTING. THE CUSTOMER REPORTED HAVING A HEADACHE AND SWEATING AT THE TIME OF THE CALL. 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 THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2020 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER DID NOT WANT TO PROVIDE ANY FURTHER INFORMATION ABOUT HER METER). CALLING CUSTOMER BACK FROM A VOICEMAIL THAT WAS LEFT. CUSTOMER STATES THAT SHE WANTS TO KNOW WHAT HI MEANS ON THE METER. I REVIEW WITH CUSTOMER WHAT HI MEANS. CUSTOMER STATES THAT SHE GETS EXTREMELY HIGH AND LOWS RESULTS AND SHE IS NOT CONCERNED. CUSTOMER STATES THAT THE HER DOCTOR IS AWARE OF THE HIGH RESULTS SHE HAVE BEEN GETTING. CUSTOMER IS NOT CONCERN

  Patient problems: Headache; Sweating

  MAUDE report 7168751 ↗
• MalfunctionJan 5, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 119, 133 AND 110 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 175 TO 220 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 BEDROOM. 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 181 AND 185 MG/DL USING TRUE BALANCE METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/15/2017 AND OPEN VIAL DATE IS 2 WEEKS AGO. THE TEST THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING LOW AFTER MEALS. CUSTOMER IS CONCERNED THAT FASTING RESULTS OBTAINED AFTER MEALS OF 119 MG/DL, 133 MG/DL AND 110 MG/DL ARE TOO LOW FOR HER ESPECIALLY IF SHE HAS EATEN FOOD SHE SHOULD NOT HAVE EATEN. CUSTOMER IS STORING TEST STRIPS CORRECTLY AND STATES SHE OPENED A NEW VIAL (LOT BT5047) AND HER READING ARE FINE. CUSTOMER IS AWARE VIAL WILL SOON EXPIRE IN A FEW DAYS BUT STATES S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7167543 ↗
• MalfunctionDec 29, 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 191 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) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 100 MG/DL AND 85 MG/DL USING TRUEBALANCE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/14/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING HIGH. CUSTOMER STATES THE METER READ 191 MG/DL FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7154038 ↗
• MalfunctionDec 14, 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 219 MG/DL AND FROM FASTING BACK TO BACK COMPARISON BLOOD GLUCOSE TEST RESULTS REPORTED BY DOCTOR'S LAB RESULT OF 105 MG/DL AND THE TEST RESULT REPORTED USING TRUEBALANCE METER OF 172 MG/DL. CUSTOMER STATED THE COMPARISON RESULTS WERE THIRTY MINUTES APART. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 - 110 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, BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER AS CUSTOMER DID NOT HAVE TEST STRIPS AND COULD NOT PROVIDE ANY TEST STRIP INFORMATION. THE PRODUCT STORAGE WAS UNDISCLOSED BUT CUSTOMER DID STATE THAT THEIR POWER HAD BEEN OUT FOR A WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING HIGH. CUSTOMER STATES THE METER READ 172 MG/DL FASTING AND LAB READ 105 MG/DL FASTING. CALLER STATES THE RESULTS WERE 30 MINUTES APART. CUSTOMER STATES SHE IS ALSO CONCERNED WITH THE 219 MG/

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7118442 ↗
• MalfunctionDec 13, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING WEAK AND TIRED. THE CUSTOMER DECLINED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; THE CUSTOMER HAD DISCONNECTED THE CALL. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/29/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue; Weakness

  MAUDE report 7114082 ↗
• MalfunctionDec 8, 2017Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS AT THE TIME OF CALL HOWEVER ON THE FOLLOW UP CALL THE CUSTOMER WAS HAVING CONTRACTIONS AND WAS ON HER WAY TO THE HOSPITAL. POSSIBLE MEDICAL ATTENTION IS REPORTED AS A RESULT OF REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/13/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. WE VERIFIED THAT NO NEW BATTERY WAS USED. METER DOES NOT TURN ON. ON FOLLOW- UP ATTEMPT ON (B)(6) 2017; CUSTOMER INFORMED THAT SHE WAS ON HER WAY TO THE HOSPITAL DUE TO A HIGH RESULT SHE OBTAINED WITH ANOTHER METER. CUSTOMER HAS GESTATIONAL DIABETES AND IS HAVING CONTRACTIONS. CUSTOMER IS FOUR MONTHS PREGNANT. WHILE CUSTOMER WAS WAITING FOR THE NEW METER TO ARRIVE, SHE BORROWED HER FRIEND METER TO TEST. THE RESULTS WAS 300MG/DL FASTING. DUE TO THE OTHER METER'S RESULTS OF 300MG/DL FASTING AND THE CUSTOMER'S SYMPTOMS (CONTRACTIONS), CUSTOMER WENT TO SEEK MEDICAL INTERVENTION. PLEASE NOTE, CUSTOMER HAS RECEIVED NEW PRODUC

  Patient problems: Hyperglycemia; No Code Available

  MAUDE report 7100868 ↗
• MalfunctionNov 29, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS.THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 214, 225, 234 AND 260 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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. THE CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2017. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/21/2018 AND OPEN VIAL DATE IS 11/07/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :214 MG/DL DATE:(B)(6) TIME:6:22 PM FASTING. RESULT 2 :225 MG/DL DATE:(B)(6) TIME:6:13 PM FASTING. RESULT 3 :234 MG/DL DATE:(B)(6) TIME 6:09 PM FASTING. RESULT 4 :260 MG/DL DATE:(B)(6) TIME:12:42 PM FASTING. CUSTOMER STATES THAT RESULTS ARE HIGHER THAN NORMAL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7069177 ↗

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