TRUE METRIX TRUE METRIX self monitoring blood glucose meter - FREE METER ONLY (REF RE4089-00)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00052569138557), received between Nov 29, 2016 and Dec 20, 2018 — classified as 82 malfunctions.

The most frequently reported specific device problem is “High Test Results” (49 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 408 AND 355 MG/DL. CUSTOMER WAS NOT CONCERNED WITH HIGH RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170 - 210 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. A PAST ADVERSE EVENT WAS REPORTED. ON (B)(6) 2018, THE CUSTOMER HAD NOT BEEN ABLE TO STAND AND THE AMBULANCE HAD BEEN CALLED. AT THE HOSPITAL THE CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS GIVEN IV FLUIDS AND AN INSULIN DRIP. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL WAS 439 MG/DL NON-FASTING. THE CUSTOMER HAD BEEN HOSPITALIZED FROM (B)(6) 2018 - (B)(6) 2018. A NEW MEDICATION WAS SUGGESTED; CUSTOMER WAS PLACED ON INSULIN. DURING THE CALL ON (B)(6) 2018, A BACK-TO-BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 310 MG/DL AND 323 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 02/17/2020, AND OPEN VIAL DATE

  Patient problems: Hyperglycemia

  MAUDE report 8185138 ↗
• 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 REPORTED FEELING ILL WITH SYMPTOMS OF DRY MOUTH, INCREASED THIRST AND INCREASED URINATION. CUSTOMER WAS GOING TO GO TO THE DOCTOR. CUSTOMER WAS UNABLE TO CONTINUE WITH THE TROUBLESHOOTING PROCESS AND NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 8106966 ↗
• MalfunctionNov 16, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140-170MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT 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 10/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). RESULT 1:220MG/DL, DATE: (B)(6) 2018 TIME:6:26PM, FASTING. RESULT 2:LO, DATE: (B)(6) 2018 TIME:5:51PM FASTING. RESULT 3:202MG/DL, DATE:(B)(6) 2018 TIME:9:31AM FASTING. RESULT 4:200MG/DL, DATE:(B)(6) 2018 TIME:7:12PM FASTING. RESULT 5:288MG/DL, DATE:(B)(6) 2018 TIME:1:13PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8078631 ↗
• MalfunctionOct 9, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF HEADACHE AND EXTREME THIRST. 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/ LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 183MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/29/2019 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 STATED THAT STRIPS ARE STORED IN THE DINING ROOM/LIVING ROOM BUT WAS USING ALCOHOL PADS WHEN TESTING. EDUCATED CUSTOMER ON THE PROPER TECHNIQUE AND HAND WASHING.

  Patient problems: Headache; Polydipsia

  MAUDE report 7949357 ↗
• MalfunctionSep 27, 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-5 ERROR ACCOMPANIED WITH SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF HAVING DRY MOUTH, THIRST AND SLEEPINESS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. PRODUCT STORAGE LOCATION IS UNDISCLOSED. 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 USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Lethargy; Polydipsia

  MAUDE report 7914826 ↗
• MalfunctionAug 30, 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 150 TO 225MG/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 (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). THE CUSTOMER WAS COMPARING THE RIGHT HAND TO THE LEFT HAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7832459 ↗
• MalfunctionAug 29, 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 146 AND 192 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. CUSTOMER STATED THIS IS THE FIRST DAY USING THE TRUEMETRIX METER. 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 CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 200 AND 196 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 10/13/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER SAYS THIS IS HIS FIRST DAY USING THE METER, HIS STRIPS ARE STORED PROPERLY, AND HIS HANDS ARE CLEAN AND DRY. CUSTOMER IS NOT USING ALCOHOL WIPES ON FINGERS. CUSTOMER DOES NOT HAVE ANY CONTROL SOLUTION. CUSTOMER RAN BACK TO BACK BLOOD TEST ON METER. CUSTOMER WANTS A REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7826896 ↗
• MalfunctionAug 28, 2018Unable to Obtain Readings; Ambient Temperature Problem; Unable to Obtain Readings; Ambient Temperature Problem

  CONSUMER REPORTED COMPLAINT FOR E-1 ERROR CODE ACCOMPANIED BY SYMPTOM. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF SHAKINESS AND DIZZINESS HOWEVER CUSTOMER DOES NOT WISH TO SEEK MEDICAL ATTENTION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL 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-1 USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/29/2019 AND OPEN VIAL DATE IS DATE. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 7822444 ↗
• MalfunctionAug 28, 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 244, 248, 238, 274 AND 302 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 MG/DL. CUSTOMER ALSO STATED SHE HAS OBTAINED RESULTS IN THE 500'S; AFTER REVIEWING THE METER MEMORY, CUSTOMER IS UNABLE TO SEE ANY RESULTS IN THE 500'S AND THOUGHT THAT MAYBE SHE HAD MADE A MISTAKE. 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 CUSTOMER'S PURSE OR CAR. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/26/2019; TEST STRIPS ARE EXPIRED BASED ON OPEN VIAL DATE OF FOUR MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7822394 ↗
• MalfunctionAug 6, 2018Unable to Obtain Readings; High Test Results; Unable to Obtain Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR CODE. THE E-5 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF HI USING TRUEMETRIX METER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER WAS GOING TO GO THE HOSPITAL AND WAS NOT ABLE TO CONTINUE THE TROUBLESHOOTING PROCESS. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754050 ↗
• MalfunctionJul 31, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. (B)(6), MOM, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH METER TO METER COMPARISON USING TRUE METRIX METER OF 95 MG/DL AND ANOTHER METER OF 39 MG/L. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 115 MG/DL. THE CUSTOMER FEELS WELL AND DID 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. 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 1/13/2019 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). MOTHER WAS CALLING FOR THE SON WHO IS (B)(6) AND DOES HIS OWN BLOOD GLUCOSES. HE DOES USE ALCOHOL PRIOR TO STICKING HIMSELF. SHE IS NOT AWARE OF HOW MANY TIMES HE DOES RUNS HIS BLOOD TESTS. SHE WAS HAVING A DIFFICULT TIME GIVING ME THE INFORMATION OUT OF THE METER'S MEMORY AND WAS NOT AWARE OF THE LOW READINGS WHEN WE BROUGHT UP THE MEMORY. SHE SAID HE DOES NOT EAT RIGHT. BUT TODAY WHEN THE BLOOD RESULTS CAM

  Patient problems: Hypoglycemia; No Information

  MAUDE report 7736219 ↗
• MalfunctionJul 11, 2018High Test Results; High Test Results

  CUSTOMER CALLED IN STATES THE METER IS READING HI DISPLAY NOT FASTING. CUSTOMER REFUSED TO PROVIDE ME WITH THE LOT NUMBER OF TEST STRIPS AND STATES SHE JUST WANTED TO KNOW WHAT HI INDICATES. 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 AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS REFUSED BY THE CUSTOMER. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. SHE DECLINED TO ANSWER FURTHER QUESTIONS AND CUSTOMER DISCONNECTED PHONE CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7677204 ↗
• MalfunctionJul 6, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 AND HI 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 BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER IS FEELING SHAKY. THE CUSTOMER STATED THAT METER IS DISPLAYING E-5 WHEN THE BLOOD IS APPLIED TO THE TEST STRIP. UPON TROUBLESHOOTING, UNABLE TO CONFIRM THE ERROR MESSAGE AND ASKED THE CUSTOMER TO PERFORM A BLOOD TEST. THE CUSTOMER GOT A RESULT OF HI. THE CUSTOMER IS FEELING SHAKES. I ADVISED THE CUSTOMER AND HER HUSBAND TO SEEK MEDICAL ATTENTION.

  Patient problems: Shaking/Tremors

  MAUDE report 7667490 ↗
• MalfunctionJul 3, 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 TO 140MG/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 202 AND 176MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7659456 ↗
• MalfunctionJun 26, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR CODE. PHARMACIST IS CALLING ON BEHALF OF THE CUSTOMER. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. CUSTOMER HAD PERFORMED SIX BLOOD TESTS IN A ROW AND WAS NOT ABLE TO OBTAIN A RESULT. CUSTOMER WAS USING PROPER TESTING TECHNIQUE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/24/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. THE CUSTOMER DECLINED TO PERFORM A BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. PHARMACIST WILL TAKE CUSTOMER TO HIS DOCTOR IN ORDER TO GET A READING AND VERIFY WHAT COURSE OF ACTION NEEDS TO BE TAKEN.

  Patient problems: Hyperglycemia

  MAUDE report 7639237 ↗
• MalfunctionJun 26, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 46 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED WHEN SHE HAD OBTAINED THE RESULT OF 46 MG/DL SHE WAS FEELING SHAKY. CUSTOMER HAD SOME JUICE AND GLUCOSE TABS, TESTED AGAIN AND OBTAINED 61 MG/DL NON-FASTING. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. CUSTOMER ALSO STATED SHE WAS COMPARING THE TRUEMETRIX METER WITH HER TRUETRACK METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/28/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :61MG/DL DATE:(B)(6) 2018 TIME:09:32AM NON-FASTING, RESULT 2 :46MG/DL DATE:(B)(6) 2018 TIME:09:23AM FASTING, RESULT 3 :104MG/DL DATE:(B)(6) 2018 T

  Patient problems: Shaking/Tremors

  MAUDE report 7639210 ↗
• MalfunctionJun 22, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 386MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 160MG/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 05/31/2019 AND OPEN VIAL DATE IS FEW DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT SHE RUN A BLOOD TEST AND GOT 386MG/DL THEN BACK TO BACK AND GOT 173/175/197 MG/DL FASTING. THESE TESTS WERE DONE ON THE SAME AND DIFFERENT FINGER. CUSTOMER IS CONCERN WITH ERRATIC BLOOD RESULTS. CUSTOMER STATES THAT HER NORMAL GLUCOSE IS 100-160MG/DL FASTING AND SHE TEST 4-5 TIMES A DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7629282 ↗
• MalfunctionJun 11, 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 154, 497, 150 AND 156 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 114 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 150 MG/DL AND 162 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP MANUFACTURER'S EXPIRATION DATE IS 05/18/2019 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 7586560 ↗
• MalfunctionJun 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. WIFE 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 300MG/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 HI AND HI USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/16/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:HI DATE: (B)(6) 2018 TIME: 12:19 FASTING, RESULT 2:288MG/DL DATE: (B)(6) 2018 TIME:12:53AM FASTING, RESULT 3:378MG/DL DATE: (B)(6) 2018 TIME:9:03PM FASTING, RESULT 4:319MG/DL DATE: (B)(6) 2018 TIME:11:36AM FASTING, RESULT 5:169MG/DL DATE: (B)(6) 2018 TIME:12:19AM FASTING. HUSBAND STATES HE RAN A BLOOD TEST AND GOT E-5 AFTER 10 TRIES. CUSTOMER THEN RUN A BLOOD TEST AND GOT HI FASTING. CUSTOMER STATES THAT HE IS A BAD DIABETIC AND SHE K

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7570791 ↗
• MalfunctionJun 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 250 TO 326 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 MEDICINE CABINET. 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 HI AND HI MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/16/2019 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). CUSTOMER ONLY CONDUCTED TWO READINGS FROM HISTORY OF METER THIRD READING 326 MG/DL CUSTOMER COULD NOT CLARIFY IF IT WAS A FASTING OR NOT FASTING READING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7569386 ↗
• MalfunctionMay 16, 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 223, 274, 302, 214 AND 256 MG/DL. CUSTOMER ALSO STATED THE TRUEMETRIX METER WAS READING HIGHER THAN HER OTHER TRUEMETRIX METER AND DR.'S METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 175 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 199 MG/DL AND 202 MG/DL USING TRUEMETRIX METER. 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 7519239 ↗
• MalfunctionMay 1, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR 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 555 AND 174 MG/DL AND 152 AND 448 MG/DL. CUSTOMER IS NOT CONCERNED THAT THE RESULTS WERE HIGH. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 171 MG/DL AND 167 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST TRIP 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). CUSTOMER CALLED STATING HIS BLOOD SUGAR IS READING ERRATICALLY. CUSTOMERS REGULAR FASTING RANGE IS 120-140MG/DL. CUSTOMER GOT A READING OF 448MG/DL FASTING AND THEN 152MG/DL FASTING WITHIN A MINUTE FROM EACH OTHER. CUSTOMER ALSO GOT A READING OF 555MG/DL FASTING AND THEN A READING OF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7477637 ↗
• MalfunctionApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF HEADACHE AND 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 BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 159 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/13/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED IN FOR ASSISTANCE RUNNING BLOOD TEST. CUSTOMER STATES SHE HAS BLURRY VISION AND A HEADACHE. HAD CUSTOMER PERFORM BLOOD TEST: RESULT: 159 MG/DL (FASTING STATUS NOT DISCLOSED). CUSTOMER SATISFIED WITH THE PRODUCT AFTER PROPER TRAINING DURING THE TIME OF THE CALL.

  Patient problems: Blurred Vision; Headache

  MAUDE report 7446800 ↗
• MalfunctionApr 3, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. 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. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 5/24/2019 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: HI, DATE:(B)(6), TIME: 7:15 PM, FASTING. RESULT 2: HI, DATE:(B)(6), FASTING. CUSTOMER DID NOT HAVE HIS OLD METER, SO HIS WIFE BOUGHT THIS METER AND THEY BROUGHT IT HOME AND DID 2 BLOOD TESTS. EACH RESULTS READ HI FASTING WITH NO SYMPTOMS. HE HAD NOT TAKEN HIS INSULIN AND IT WAS ABOUT 5-6 HOURS AFTER EATING HIS LUNCH. THE CUSTOMER AND WIFE CALLED TO INQUIRE ABOUT THE HI RESULT. I EXPLAINED THAT THE METER READS HI IF BLOOD GLUCOSE RESULTS ARE OVER 600 MG/DL. THE WIFE, WHO IS NOT A DIABETIC, RAN HER BLOOD

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7391891 ↗
• MalfunctionMar 21, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 313, 435, 385 331 MG/DL AND HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 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 NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 3/31/19 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:313 MG/DL DATE:(B)(6) 2018 TIME:9:33AM FASTING, RESULT 2:435 MG/DL DATE:(B)(6) 2018 TIME:8:00AM FASTING, RESULT 3:HI DATE:(B)(6) 2018 TIME:10:30PM FASTING, RESULT 4:385 MG/DL DATE:(B)(6) 2018 TIME:5:30PM FASTING, RESULT 5:331 MG/DL DATE:(B)(6) 2018 TIME:12:30PM FASTING. CUSTOMER HAS NOT HAD ANY CHANGES TO HIS EXERCISE, DIET, MEDICATION OR LIFESTYLE ROUTINE. CUSTOMER STATED THAT HIS LAST A1C WAS 8.3 IN (B)(6) OF 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358392 ↗