TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - FREE METER ONLY (REF RE4H01-00)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00021292006082), received between Nov 22, 2016 and Jan 24, 2019 — classified as 75 malfunctions.

The most frequently reported specific device problem is “High Test Results” (39 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-140MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DEN. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 5/31/2020, AND OPEN VIAL DATE IS APPROXIMATELY 3-5 DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER FIRST CALLED BECAUSE OF ERROR MESSAGES HE DID NOT KNOW WHAT IT WAS THEN WE RAN A BLOOD AND THE METER READING 21MG/DL THEN RAN THE BLOOD AGAIN AND IT READ LO WITH NO SYMPTOMS. CUSTOMER CONFIRMED THAT HE CLOSES THE LID ON THE STRIPS WITH EVERY USE. HE JUST OPENED THIS VIAL ABOUT 3-5 DAYS AGO WITH NO PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8275443 ↗
• MalfunctionDec 27, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULT OF 166 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS AT THE TIME OF THE CALL. WHEN CUSTOMER HAD OBTAINED THE RESULT OF 166 MG/DL, HE HAD FELT PHYSICALLY WELL BUT HAD MADE AN APPOINTMENT WITH HIS DOCTOR WHO HAD ADVISED HIM TO OBTAIN A NEW METER. 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 129 MG/DL AND 123 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 02/29/2020 AND OPEN VIAL DATE IS (B)(6) 2018. CUSTOMER WAS NOT CONCERNED WITH THE RESULT OF 78 MG/DL IN THE METER MEMORY; CUSTOMER STATED THAT HE HAD FELT DIZZY AT THE TIME AND THAT HIS BLOOD SUGAR COULD HAVE BEEN LOW. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :135MG/DL DATE: (B)(6) 2018 TIME:6:47AM FASTING; RESULT 2 :166MG/DL DATE: (B)(6) 2018 TIME:9:13AM FASTING (F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199738 ↗
• MalfunctionDec 26, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A NON-FASTING BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI AND HI DISPLAY USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 4/16/19 AND OPEN VIAL DATE IS 6 WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH THE HIGH RESULTS THAT HE IS GETTING FROM HIS METER. CUSTOMER DENIES HAVING ANY SYMPTOMS OF HYPERGLYCEMIA AT THIS TIME AND DOES NOT NEED MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8196895 ↗
• MalfunctionNov 19, 2018Low 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 TESTS RESULTS FROM RESULTS OBTAINED OF 44 AND 55 MG/DL. CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 89 MG/DL. CUSTOMER DOES USE ALCOHOL AT TIMES ON HER FINGERS PRIOR TO TESTING. CUSTOMER'S FASTING RESULT AT DOCTOR'S OFFICE A WHILE AGO WAS 89 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 CALL ON (B)(6) 2018, 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 08/13/2019 AND OPEN VIAL DATE IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (RESULT OF 104 MG/DL IS DAUGHTER'S TEST RESULT AND IT WAS NOT KNOWN WHO THE TEST RESULT OF 89 MG/DL BELONGED TO): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084395 ↗
• MalfunctionNov 6, 2018Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER NOT FEELING PHYSICALLY WELL AND REPORT SYMPTOMS OF BLURRY VISION AND DRY MOUTH. CUSTOMER HAS NOT BEEN DIAGNOSED BUT WILL VISIT A DOCTOR TOMORROW FOR TREATMENT FOR HYPERGLYCEMIA. 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 DINING ROOM. DURING CALL ON (B)(6) 2018, BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 341MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS DATE AND OPEN VIAL DATE IS DATE. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Blurred Vision

  MAUDE report 8041540 ↗
• MalfunctionNov 2, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 207MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 104 TO 132MG/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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/28/2020 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 :101MG/DL, DATE: (B)(6) 2018, TIME:10:08AM, FASTING; RESULT 2 :207MG/DL, DATE: (B)(6) 2018, TIME:12:47PM, FASTING; RESULT 3 :119MG/DL, DATE: (B)(6) 2018, TIME:4:10PM, FASTING; RESULT 4 :111MG/DL, DATE: (B)(6) 2018, TIME:10:19AM, FASTING; RESULT 5 :147MG/DL, DATE: (B)(6) 2018, TIME:7:09PM, N/FASTING. CUSTOMER CALLED IN AND STATES THE METER GAVE HER 1 HIGH READING DURING A BACK TO BACK TEST. CUSTOMER IS CONCERNED THAT 207MG/DL FASTING IS TOO HIGH FOR HER. CUSTOMER IS STORING TEST STRIPS INCORRECTLY AND ADVISED OF PROPER STORAGE TECHNIQUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8032460 ↗
• MalfunctionOct 17, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON OF 54 MG/DL USING TRUEMETRIX METER AND 86 MG/DL USING ANOTHER DEVICE. BLOOD SAMPLES WERE TAKEN FROM THE SAME FINGER AND CUSTOMER WAS ADVISED OF PROPER TESTING TECHNIQUE. WIFE STATED CUSTOMER HAD NO SYMPTOMS OF LOW BLOOD SUGAR. CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 105 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 211 MG/DL AND 221 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM; CUSTOMER DOES TRAVEL IN AN RV CAMPER AND WAS ADVISED OF PROPER STORAGE TECHNIQUE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/16/2019 AND OPEN VIAL DATE IS THREE DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :80MG/DL DATE: (B)(6) 2018 TIME:5:32AM FASTING, RESULT 2 :54MG/DL DATE:

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7975539 ↗
• MalfunctionOct 5, 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 TESTS RESULTS FROM RESULTS OBTAINED OF HI AND 522, 593, 422 AND 193 MG/DL. CUSTOMER ALSO STATED RESULTS FROM TRUEMETRIX METER ARE 200 - 300 POINTS HIGHER WHEN COMPARED TO ANOTHER DEVICE; THE ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 315 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT AND HAD THROWN OUT THE CONTAINER BUT STATED THAT THEY WERE WITHIN DATE AND OPENED LESS THAN FOUR MONTHS AGO. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7938751 ↗
• MalfunctionOct 2, 2018Unable to Obtain Readings; Low Test Results; Unable to Obtain Readings; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR E-2 ACCOMPANIED BY SYMPTOMS. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING FATIGUE AND WEAK. 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 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 08/16/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER RECENTLY HAD OPEN HEART SURGERY. CUSTOMER FEELS FATIGUE AND WEAK. UNKNOWN IF SYMPTOMS ARE RELATED TO POST SURGERY OR DIABETES. CUSTOMER'S SISTER CALLED IN STATING THAT THE METER WAS READING E-2. DURING TROUBLESHOOTING, SISTER STATED I GOT TO GO, SHE'S ILL, SHE'S ILL AND DISCONNECTED THE CALL. IT APPEARED THAT THE CUSTOMER SYMPTOMS GOT WORSE. UNKNOWN IF THEY WILL SEEK MEDICAL INTERVENTION.

  Patient problems: Fatigue; Hypoglycemia; Weakness

  MAUDE report 7928074 ↗
• MalfunctionOct 2, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-5 AND E-5 USING TRUEMETRIX METER. CUSTOMER STATED SHE WAS USING CORRECT TESTING TECHNIQUE. AT THE TIME OF THE CALL, THE CUSTOMER STATED THAT SHE WAS TIRED, HAD DRY MOUTH, INCREASED THIRST AND INCREASED URINATION. CUSTOMER WAS GOING TO SEEK MEDICAL INTERVENTION DUE TO SYMPTOMS. CUSTOMER WAS UNABLE TO CONTINUE WITH THE TROUBLESHOOTING PROCESS AND NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Fatigue; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7927051 ↗
• MalfunctionAug 23, 2018Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  CONSUMER 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 OCCURRED AS SOON AS THE TEST STRIP WAS INSERTED. THE CUSTOMER WAS USING INCORRECT TESTING TECHNIQUE. CUSTOMER WAS ERRONEOUSLY APPLYING THE SAMPLE TO THE TEST STRIP FIRST AND THEN INSERTING IT INTO THE METER. AT THE TIME OF THE CALL THE CUSTOMER STATED THAT SHE FELT LIGHT HEADED AND HAD BLURRY VISION. CUSTOMER DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 102 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Blurred Vision

  MAUDE report 7810679 ↗
• MalfunctionJul 17, 2018Low 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 141 AND 121 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 250 MG/DL. THE CUSTOMER WAS ALSO CONCERNED WITH HIGH BLOOD GLUCOSE TEST RESULTS OBTAINED OF 255 AND 314 MG/DL. CUSTOMER STATED HE HAD TAKEN THE TRUEMETRIX METER TO A SCHEDULED DOCTOR'S APPOINTMENT AND THE TRUEMETRIX METER READ 100 POINTS LOWER THAN THE DOCTOR'S METER. ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. 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. PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2019 AND OPEN VIAL DATE IS ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7695906 ↗
• MalfunctionJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR SYMPTOMS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF NOT EATING AND FEELING WEAK TIRED. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. 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 UNDISCLOSED AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. MOTHER STATED THAT DAUGHTER WAS NOT EATING AND WAS VERY WEAK AND TIRED. THE AMBULANCE WAS CALLED. MOTHER STATED THAT DAUGHTER WAS HOSPITALIZED BUT DOES NOT RECALL BLOOD GLUCOSE METER OR LAB RESULTS. MOTHER STATED THAT DAUGHTER WAS IN THE HOSPITAL AND THEN TRANSFERRED TO A REHAB FACILITY FROM THE MONTHS OF (B)(6) TO (B)(6). MOTHER DID NOT KNOW THE EXACT DATES OF THE HOSPITALIZATION AND/OR THE EXACT DATES THAT HER DAUGHTER WAS IN SENT TO REHAB. MOTHER STATED THAT SHE NO LONGER USES THAT METER AND PURCHASED A NEW ONE FOR HER DAUGHTER. MOTHER DID STATE THAT SHE WOULD RETURN METER FOR INVESTIGATION. MOTHER CHOSE

  Patient problems: Weakness

  MAUDE report 7629148 ↗
• MalfunctionJun 21, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH ACCOMPANIED BY SYMPTOMS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 215MG/DL (NON-FASTING). THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER DID REPORT SYMPTOMS OF BLURRY VISION. MEDICAL ATTENTION IS NOT 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 BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/21/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER WAS NOT FEELING WELL AND WILL SEEK MEDICAL ATTENTION.

  Patient problems: Blurred Vision

  MAUDE report 7626476 ↗
• MalfunctionMay 24, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. IN REVIEWING THE METER MEMORY, CUSTOMER WAS UNSURE WHICH RESULTS SHE WAS CONCERNED WITH. CUSTOMER ALSO MENTIONED SHE HAD OBTAINED A RESULT OF 150 MG/DL USING TRUEMETRIX METER AND 197 MG/DL USING ANOTHER DEVICE; CUSTOMER WAS NOT SURE IF RESULTS WERE FASTING OR NON-FASTING. THE CUSTOMER'S DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE, BUT STATED SHE WOULD LIKE TO STAY BETWEEN 100 - 120 MG/DL FASTING. 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 STORED ACCORDING TO SPECIFICATION ON THE DINING ROOM TABLE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. CUSTOMER DOES NOT ALWAYS TEST FASTING AND WAS NOT SURE IF THE RESULTS IN THE METER MEMORY WERE PERFORMED FASTING OR NON-FASTING. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7540313 ↗
• MalfunctionMay 18, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 WHEN BLOOD SAMPLE IS ABSORBED ACCOMPANIED BY SYMPTOMS. 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 STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 79 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/27/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Shaking/Tremors

  MAUDE report 7526830 ↗
• MalfunctionMay 7, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 56,59,75,60 AND 62MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 114 MG/DL AND 109 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/25/2018 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7491516 ↗
• MalfunctionMay 4, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. CUSTOMER'S DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 84, 63, 51 AND 68MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 200MG/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 NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/19/2019 AND OPEN VIAL DATE IS LAST WEEK. 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 7487833 ↗
• MalfunctionMay 2, 2018High 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, 332, 343, 180 AND 309 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS UNDER 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 NOT PERFORMED BY THE CUSTOMER; CUSTOMER WAS NOT FASTING AT TIME OF CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/16/2019 AND CUSTOMER DID NOT KNOW WHEN THE VIAL HAD BEEN FIRST OPENED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481035 ↗
• MalfunctionApr 24, 2018High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER WAS NOT USING PROPER TESTING TECHNIQUE. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 565 MG/DL USING TRUEMETRIX METER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS, BUT WAS CONCERNED ABOUT THE HIGH RESULT OBTAINED OF 565 MG/DL. CUSTOMER WAS GOING TO SEEK MEDICAL ATTENTION. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/16/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Blurred Vision; Dizziness; Hyperglycemia

  MAUDE report 7454552 ↗
• MalfunctionApr 20, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 489, 436, 586, 337 AND 444 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 225 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 09/30/2018 AND CUSTOMER WAS UNSURE OF OPEN VIAL DATE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7447106 ↗
• MalfunctionMar 26, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT OF E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE E-3 ERROR OCCURRED AS SOON AS THE TEST STRIP WAS INSERTED INTO THE METER. 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. BLOOD TEST PERFORMED DURING CALL ON (B)(6) 2018 PRODUCED RESULT OF E-3. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/13/2019 AND OPEN VIAL DATE WAS UNDISCLOSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7370718 ↗
• MalfunctionMar 15, 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 232 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 125 MG/DL. CUSTOMER ALSO STATED SHE WOULD PERFORM BACK TO BACK TEST AND GET A BIG DIFFERENCE IN HER RESULTS, HOWEVER BACK TO BACK TEST WAS PERFORMED NOT USING THE SAME HAND. CUSTOMER WAS INFORMED OF PROPER TESTING TECHNIQUE. 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; CUSTOMER WAS INFORMED OF PROPER STORAGE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/23/2018 AND OPEN VIAL DATE IS ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:119MG/DL (B)(6) 8:39AM FASTING, RESULT 2:143MG/DL (B)(6) 8:37AM FASTING, RESULT 3:132MG/DL (B)(6) 7:48AM FASTING, RESULT 4:159MG/DL (B)(6) 10:39PM NON FASTING, RESULT 5:232MG/DL (B)(6) 7:57PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7343224 ↗
• MalfunctionMar 6, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. NIECE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF E-0. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF HAVING A HEADACHE. CUSTOMER STATES SHE HAS A HEADACHE, DOES NOT KNOW IF IT IS RELATED TO DIABETES. MEDICAL ATTENTION IS NOT 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 BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-0 USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CALLER STATES SHE WILL CALL 9-1-1 SO PARAMEDIC CAN COME AND TEST HER SUGAR SINCE THE METER IS ONLY GIVING HER AN E-0.

  Patient problems: Headache

  MAUDE report 7317211 ↗
• MalfunctionMar 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 73 AND 330MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 112 TO 149MG/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 LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 134 AND 146MG/DL USING TRUE MERIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). RESULT 1 :171MG/DL DATE: (B)(6) 2018 TIME:11:26AM FASTING, RESULT 2 :330MG/DL DATE: (B)(6) 2018 TIME:07:58AM FASTING, RESULT 3 :73MG/DL DATE: (B)(6) 2018 TIME:02:21AM FASTING, RESULT 4 :205MG/DL DATE: (B)(6) 2018 TIME:08:49PM FASTING, RESULT 5 :260MG/DL DATE: (B)(6) 2018 TIME:06:34PM FASTING, CUSTOMER CALLED SAYING HER BLOOD SUGAR IS NOT BEING READ ACCURATELY ON HER METER. CUSTOMER CALLED TO COMPLAIN ABOUT L

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7313317 ↗