TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter (REF RE4007-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00050428275283), received between Jan 6, 2017 and Jan 2, 2019 — classified as 65 malfunctions.

The most frequently reported specific device problem is “High Test Results” (42 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150MG/DL. THE CUSTOMER 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 LIVING ROOM. 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 03/27/2020 AND OPEN VIAL DATE IS 12/6/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT SHE RUN A BLOOD TEST AND GOT HI NON FASTING. CUSTOMER HAVE BEEN SIPPING ON A COKE. CUSTOMER STATES THAT HER NORMAL GLUCOSE RANGE IS 150MG/DL FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8208439 ↗
• MalfunctionDec 17, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK-TO-BACK BLOOD TESTS OF 289 AND 363 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 150 MG/DL. CUSTOMER DOES USE ALCOHOL ON FINGERS PRIOR TO TESTING AND WAS ADVISED 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 STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019, AND OPEN VIAL DATE IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8169357 ↗
• MalfunctionNov 30, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 183 AND 206 MG/DL FASTING AND FROM BACK TO BACK TEST RESULTS OF 208 AND 193 MG/DL NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 90 MG/DL; CUSTOMER DOES NOT KNOW THEIR EXPECTED NON-FASTING RANGE. CUSTOMER WAS USING ALCOHOL WIPES. 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 197 MG/DL AND 210 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 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 8119733 ↗
• MalfunctionNov 27, 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. AT THE TIME OF THE CALL, THE CUSTOMER STATED HE WAS FEELING DIZZY AND SHAKY. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER WAS USING PROPER TESTING TECHNIQUE. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF E-5 USING TRUEMETRIX METER.

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 8107781 ↗
• MalfunctionNov 16, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 173, 166 AND 202 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 88 - 101 MG/DL. CUSTOMER WAS USING CORRECT 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 STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/15/2020 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 8078266 ↗
• MalfunctionOct 25, 2018Failure to Power Up; Unable to Obtain Readings; Failure to Power Up; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR DEAD METER ACCOMPANIED BY SYMPTOM. METER WILL NOT TURN ON WITH TEST STRIP BUT PRESSING THE DOT BUTTON METER CAME ON. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 2/29/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER JUST PURCHASED THE METER OVER THE WEEKEND.

  Patient problems: Headache

  MAUDE report 8006300 ↗
• MalfunctionOct 22, 2018High 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 E-5 AFTER BLOOD IS APPLIED ACCOMPANIED BY 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 FEELING NAUSEOUS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 7992060 ↗
• MalfunctionAug 29, 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 47 AND 53MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 160MG/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 WAS NOT ABLE TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) /2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 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 7828167 ↗
• MalfunctionAug 7, 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 FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 350 MG/DL. CUSTOMER IS AWARE THAT THIS IS HIGH AND STATED THAT HER BLOOD SUGAR HAS BEEN HIGH LATELY. CUSTOMER HAS ONLY BEEN USING THE TRUEMETRIX METER FOR A MONTH. 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 HI AND E-5 USING TRUEMETRIX METER. DURING THE CALL, CUSTOMER STATED THAT SHE HAD NOT YET TAKEN HER INSULIN. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2019 AND OPEN VIAL DATE IS 2 - 3 WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT SHE HAS BEEN TRYING TO RUN HER BLOOD SUGAR AND ALL SHE IS GETTING IS HI. CUSTOMER STATES THAT SHE HAS ONLY BEEN USING THE METER FOR A MONTH NOW. CUSTOMER STATES SHE IS FEELING FINE, SHE ALWAYS HAS HIGH BL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7759104 ↗
• MalfunctionJul 5, 2018Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL RESULTS. THE CUSTOMER IS CONCERNED WITH CONTROL RESULTS OBTAINED OF 66 AND 71MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. 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 DEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664688 ↗
• MalfunctionMay 24, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF EXCESSIVE THIRST AND FATIGUE. 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. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER UNABLE TO ANSWER ANY FURTHER QUESTIONS DUE TO SYMPTOMS. CUSTOMER ENDED THE CALL.

  Patient problems: Fatigue; Polydipsia

  MAUDE report 7541657 ↗
• MalfunctionMay 24, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 CODE. THE E-5 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING LIGHTHEADED AND WEAK. CUSTOMER DECLINED MEDICAL ATTENTION AT THE TIME OF THE CALL BUT WAS ADVISED TO SEEK MEDICAL ATTENTION IF NEEDED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 529 MG/DL USING TRUEMETRIX METER; CUSTOMER HAD DRANK MILK AND TOOK MEDICINE PRIOR TO TESTING. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia; Weakness

  MAUDE report 7540410 ↗
• MalfunctionMay 17, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM NON-FASTING RESULT OBTAINED OF 195 MG/DL. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 - 131 MG/DL; EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 90 MG/DL. CUSTOMER WAS NOT CONCERNED WITH ERRATIC RESULTS. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOM OF EXCESSIVE THIRST. CUSTOMER STATED SHE HAD FELT THAT WAY FOR SOME TIME AND THAT SHE HAS BEEN IN COMMUNICATION WITH HER DOCTOR ABOUT IT. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 198 MG/DL AND 114 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN A WALK IN CLOSET. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. CUSTOMER HAD TWO VIALS OF THE SAME LOT NUMBER OF TEST STRIPS AND CUSTOMER STATED SHE HAD OBTAINED HIGH RESULTS WITH BOTH VIALS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Headache; Polydipsia

  MAUDE report 7521983 ↗
• MalfunctionMay 15, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR: SAMPLE NOT DETECTED OR USING WRONG TEST STRIP. THE E-2 ERROR OCCURRED ONCE THE BLOOD SAMPLE WAS ABSORBED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOM OF BLURRY VISION; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF E-2 USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. CUSTOMER WAS USING THE CORRECT TEST STRIPS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Blurred Vision

  MAUDE report 7514800 ↗
• MalfunctionMay 10, 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 100 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 FAMILY 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 2/28/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER WAS TRANSFERRED TO ME, AND SHE IS GETTING HIGH BLOOD RESULTS, SINCE HER DAUGHTER IS A DR. SHE TOLD ME SHE KNOWS THIS METER IS NOT WORKING CORRECTLY. SHE HAS HAD IT FOR ONLY 2 MONTHS AND IT WAS WORKING FINE THE LAST LOT OF STRIPS SHE IS GETTING HIGH BLOOD RESULTS. THE CUSTOMER WAS UPSET SO EVERY TIME ASKING MORE QUESTIONS WAS IRRITATING HER MORE AND MORE UNTIL FINALLY HER HUSBAND CAME ON THE PHONE. SHE KNOWS HOW TO APPLY BLOOD SINCE HER DAUGHTER IS A DR. SHE TOOK HER METER TO THE DR. AND HER METER READ AT HOME 200 MG/DL AND ONE HOUR LA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502986 ↗
• MalfunctionMay 2, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 144, 149, 147 AND 170MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-120MG/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 KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER DOES NOT HAVE ANY MORE STRIPS TO TROUBLE SHOOT AND STRIPS WERE STORED INCORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7479474 ↗
• MalfunctionApr 30, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 64, 72, 88 AND 88 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 - 120 MG/DL. CUSTOMER HAS GESTATIONAL DIABETES AND IS CURRENTLY 29 WEEKS PREGNANT. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED SHE WAS NOT EXPERIENCING ANY SYMPTOMS WHEN SHE HAD OBTAINED THE LOW TEST RESULTS. 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 65 MG/DL AND 64 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 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 7472308 ↗
• MalfunctionApr 30, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 145, 166, 239 141 AND 189 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 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 143 MG/DL AND 154 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE IS LESS THAN ONE MONTH. 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 7472184 ↗
• MalfunctionApr 30, 2018Image Display Error/Artifact; Image Display Error/Artifact

  CUSTOMER REPORTED COMPLAINT FOR DEFECTIVE LCD ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT HYPERGLYCEMIC SYMPTOMS (DID NOT SPECIFY WHICH ONE/ONES). MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. 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 REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER WAS NOT FEELING WELL AND WILL SEEK MEDICAL ATTENTION. CUSTOMER ADVISED HE IS EXPERIENCING HYPERGLYCEMIC SYMPTOMS BUT WOULD NOT DISCLOSE WHAT SYMPTOMS. CUSTOMER UNABLE TO PROVIDE LOT NUMBER OF TEST STRIP CONTAINER BECAME VULGAR AND DISCONNECTED CALL. UPON CUSTOMER'S CALL BACK ON (B)(6) 2018; CUSTOMER STATES THAT HE CAN ONLY SEE PARTIAL CHARACTERS. NO MEDICATION WAS ADMINISTERED. HE STATES THE LCD SCREEN IS NOT CRACKED AND METER WAS NEVER DROPPED. CUSTOMER DECLINED TO ANSWER QUESTION ON HOW HE WAS FEELING AT THE TIME OF CALL.

  Patient problems: Hyperglycemia

  MAUDE report 7472013 ↗
• MalfunctionApr 18, 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 120 MG/DL. THE CUSTOMER FEELS WELL ON CALL BUT DID REPORT PRIOR SYMPTOMS OF FEELING ILL AND TIRED. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE REPORTED SYMPTOMS. 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 NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 269 AND 287 MG/DL USING TRUE METRIX METER. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 7/19/19 AND OPEN VIAL DATE IS TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): (B)(6). CUSTOMER IS CONCERNED WITH BOTH THE HIGH RESULTS AND THE ERRATIC RESULTS THAT SHE IS GETTING FROM HER METER. CUSTOMER IS NOT HAVING ANY DIABETIC SYMPTOMS AT THIS TIME. CUSTOMER REPORTED AN INCIDENT THAT OCCURRED AT THE BEGINNING OF (B)(6) 2018. CUSTOMER WAS FEELING ILL AND TIRED. CUSTOMER STATED THAT SHE DOES NOT RECALL WHAT DATE THIS OCCURRED BUILT ADVISED THAT SHE WAS IN THE ER FOR 5 HOURS AND THEN RELE

  Patient problems: Fatigue; Hypoglycemia

  MAUDE report 7441672 ↗
• MalfunctionApr 18, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 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 KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 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).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441270 ↗
• MalfunctionApr 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 163, 244, 184 AND 219 MG/DL. CUSTOMER ALSO STATED THAT TRUEMETRIX METER WAS READING DIFFERENT THAN HER HUSBAND'S METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 105 - 122 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2018 SHE HAD OBTAINED A RESULT OF 210 MG/DL FASTING USING THE TRUEMETRIX METER AND THAT HER DAUGHTER HAD THEN DRIVEN HER TO THE HOSPITAL. CUSTOMER DID NOT REMEMBER WHAT HER BLOOD GLUCOSE TEST RESULT WAS AT THE HOSPITAL, ONLY THAT IT WAS HIGH. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS ADMINISTERED INSULIN. CUSTOMER WAS DISCHARGED THE SAME DAY WITH THE RECOMMENDATION TO FOLLOW UP WITH HER PCP. CUSTOMER STATED THAT AT THE HOSPITAL THE TRUEMETRIX METER READ MORE THAN 35 POINTS DIFFERENCE THAN THE DOCTOR'S RESULTS; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT I

  Patient problems: Hyperglycemia

  MAUDE report 7414583 ↗
• MalfunctionApr 9, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM FASTING RESULTS OBTAINED OF 161 AND 200 MG/DL AND WITH TESTS RESULTS FROM NON-FASTING METER TO METER COMPARISON OF 312 MG/DL USING TRUEMETRIX METER AND 149 MG/DL USING ANOTHER DEVICE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 149 MG/DL. CUSTOMER WAS ADVISED TO NOT USE ALCOHOL WHEN TESTING. 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 IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/18/2019 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 7406745 ↗
• MalfunctionMar 30, 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 160, 226 AND 156 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 140 MG/DL. CUSTOMER ALSO STATED THAT HE HAD BEEN COMPARING RESULTS TO TWO OTHER METERS AND THE TRUEMETRIX METER READ ABOUT 40 POINTS HIGHER. ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. CUSTOMER WAS USING CORRECT 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; CUSTOMER WAS NOT FASTING AT TIME OF CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 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 7386000 ↗
• MalfunctionMar 30, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 265 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 92 - 138 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 ONLY HAD TWO TEST STRIPS LEFT. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/14/2019 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 7385390 ↗