TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALE (REF RE4H01-40)Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 00021292006068), received between Dec 6, 2016 and Feb 25, 2020 — classified as 182 malfunctions.

The most frequently reported specific device problem is “High Test Results” (116 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 182 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 362, 326, 225, 324 AND 327 MG/DL. CUSTOMER STATED THAT SHE TOOK INSULIN SHORTLY AFTER OBTAINING THE RESULT OF 362 MG/DL THAT MORNING. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 200 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 129 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2021 AND TEST STRIPS HAVE BEEN OPENED FOR TWO MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752887 ↗
• MalfunctionNov 14, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW AND HIGH BLOOD GLUCOSE TEST RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL TEST RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-110MG/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 NURSING MEDICINE ROOM. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/14/2021 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9321854 ↗
• MalfunctionJan 17, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 229, 214, 164, 170 AND 166 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115 - 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 STORED ACCORDING TO SPECIFICATION IN THE DINING AREA. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2020, AND OPEN VIAL DATE IS ABOUT ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). POKE WITH HIS WIFE ABOUT THE METER READING SO HIGH FOR HIM. HE HAS NO EXERCISE OR EATING CHANGES JUST A MEDICATION THAT DID NOT AGREE WITH HIM AND WAS TOLD NOT TO TAKE IT ANYMORE. HE HAS BEEN USING THE METER FOR SEVERAL MONTHS WITH NO PROBLEMS. HE SEES AN ENDOCRINOLOGIST, BUT DOES NOT KNOW HIS A1C.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8258483 ↗
• MalfunctionJan 15, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 62 AND 64 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 120MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT WHEN OBTAINED THE RESULTS OF 62 AND 64 MG/DL, HE WAS NOT EXPERIENCING ANY SYMPTOMS OF HYPOGLYCEMIA. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON 12/19/2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/23/2020 AND OPEN VIAL DATE IS 12/19/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 62MG/DL, DATE: (B)(6) 2018, TIME:1:25 PM, FASTING; RESULT 2: 64MG/DL, DATE: (B)(6) 2018, TIME:1:24 PM, FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8247859 ↗
• MalfunctionJan 9, 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 185, 228 AND 216 MG/DL AND FROM FASTING METER TO METER COMPARISON RESULTS OF 220 MG/DL USING TRUEMETRIX METER AND 130 MG/DL USING DR.'S DEVICE. 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 NOT PERFORMED BY THE CUSTOMER; CUSTOMER WAS NOT FASTING AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE COMPUTER ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/22/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1 :168MG/DL DATE: (B)(6) 2018 TIME:01:59PM FASTING; RESULT 2 :185MG/DL DATE: (B)(6) 2018 TIME:09:33AM FASTING; RESULT 3 :228MG/DL DATE: (B)(6) 2018 TIME:06:52PM FASTING; RESULT 4 :155MG/DL DATE: (B)(6) 2018 TIME:01:22PM FASTING; RESULT 5 :216MG/DL DATE: (B)(6) 2018 TIME:07:13AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8231205 ↗
• MalfunctionJan 3, 2019Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC AND LOW BLOOD GLUCOSE TEST RESULTS (ACCOMPANIED BY SYMPTOMS). THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 59 AND 97MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-130MG/DL. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED 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 129 AND 134MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2020, AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CONCERN WITH THE RESULTS THE METER IS GIVING. CUSTOMER STATES THAT SHE RUN A BACK-TO-BACK BLOOD TEST AND 59/97MG/DL FASTING AND THE TEST WERE DONE ON THE SAME FINGER. CUSTOMER STATES THAT SHE WAS FEELING SYMPTOMS OF LOW BLOOD SUGAR WITH THE RESULTS OF 59/97.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8212446 ↗
• MalfunctionDec 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW CONTROL RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 8MG/DL. 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. 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 6/15/2019 AND OPEN VIAL DATE IS NOV. 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER JUST OPENED HIS CONTROL AND RAN THE CONTROL TEST WITH ME AND THE RESULTS WERE 8MG/DL. HE SAID HE PREVIOUSLY RAN IT SEVERAL MORE TIMES EACH TIME IT WAS VERY LOW AND THAT IS WHY HE IS CALLING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161815 ↗
• MalfunctionDec 12, 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 114 AND 148 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 110 MG/DL. CUSTOMER IS USING THE 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/23/2020 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 8157787 ↗
• MalfunctionNov 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 181, 132, 153, 140 AND 150 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 114 MG/DL. CUSTOMER IS 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. 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: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081210 ↗
• MalfunctionOct 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 56 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 82 - 134 MG/DL. 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. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/20/2019 AND OPEN VIAL DATE IS TWO MONTHS AGO. CUSTOMER STATED THAT THE RESULT OF 139 MG/DL IN THE METER MEMORY WAS NOT HIS RESULT, IT BELONGED TO SOMEONE ELSE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015950 ↗
• MalfunctionOct 24, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY ACCOMPANIED BY SYMPTOMS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER DID REPORT SYMPTOMS OF FEELING LETHARGIC 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 DINING 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 DISPLAY USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 5/16/2020 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) 2018 TIME:7:14 PM FASTING; RESULT 2:561MG/DL DATE: (B)(6) 2018 TIME:4:08 PM FASTING; RESULT 3:308MG/DL DATE: (B)(6) 2018 TIME:10:36 PM FASTING; RESULT 4:350MG/DL DATE: (B)(6) 2018 TIME:9:23 PM FASTING; RESULT 5:288MG/DL DATE: (B)(6) 2018 TIME:9:42 PM FASTING.

  Patient problems: Hyperglycemia; Lethargy; Weakness

  MAUDE report 7999791 ↗
• MalfunctionOct 12, 2018Unable to Obtain Readings; High Test Results; Unable to Obtain Readings; High Test Results

  CUSTOMER CALLED IN REQUESTING TO KNOW WHAT E-5 MEANT. THE E-5 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. INFORMED CUSTOMER THAT IT IS DUE TO A TEST STRIP ERROR OR THAT HIS BLOOD SUGAR COULD BE ABOVE 600MG/DL. AS SOON AS WE INFORMED THE CUSTOMER IT COULD BE ABOVE 600MG/DL CUSTOMER STATES, THAT'S IT. ASKED CUSTOMER IF HE HAD ANY SYMPTOMS OF HIGH BLOOD SUGAR AS I LISTED THEM CUSTOMER STATES HE HAS FREQUENT URINATION, EXCESSIVE THIRST, AND FEELS TIRED. INSTRUCTED CUSTOMER TO CALL 911 AND SEEK MEDICAL ATTENTION. INFORMED CUSTOMER WE WOULD CALL HIM BACK TOMORROW.

  Patient problems: Fatigue; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7962095 ↗
• MalfunctionOct 12, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS AND LOW CONTROL TEST RESULT. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BLOOD GLUCOSE TEST RESULTS OBTAINED OF 258, 456 AND 45 MG/DL AND OF CONTROL TEST RESULT OF 222 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 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 STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :81MG/DL DATE: (B)(6) 2018 TIME:10:24AM FASTING, RESULT 2 :258MG/DL DATE: (B)(6) 2018 TIME:07:05AM FASTING, RESULT 3 :456MG/DL DATE: (B)(6) 2018 TIME:07:30PM FASTING, RESULT 4 :142MG/DL DATE: (B)(6) 2018 TIME:05:08PM FASTING, RESULT 5 :45MG/DL DATE: (B)(6) 2018 TIME:03:21PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7960874 ↗
• MalfunctionOct 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. HUSBAND 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 115MG/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 DATE, A BACK TO BACK BLOOD TEST WAS PERFORMED NON FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 272 AND 254MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 5/24/2019 AND OPEN VIAL DATE IS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7939538 ↗
• MalfunctionSep 28, 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 69, 56 AND 62 MG/DL. CUSTOMER IS ALSO CONCERNED WITH FASTING METER TO METER COMPARISON RESULTS OF 84 MG/DL USING TRUEMETRIX METER AND 118 MG/DL USING DOCTOR'S DEVICE. CUSTOMER STATED WHEN HE OBTAINED THE LOW RESULTS HE DID NOT HAVE ANY SYMPTOMS. 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. 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 IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/27/2019 AND OPEN VIAL DATE IS THREE WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920437 ↗
• MalfunctionSep 17, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 294, 278 AND 409MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 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 NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/20/2019 AND OPEN VIAL DATE IS APPROXIMATELY ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): (B)(6). CUSTOMER STATES THAT SHE THINKS THE METER IS WORKING FINE NOW BUT IT WAS NOT WORKING THE OTHER DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7883236 ↗
• MalfunctionSep 14, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULT OBTAINED OF 91MG/DL NON-FASTING. THE EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 180 TO 300MG/DL. 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 02/17/2019 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 7877288 ↗
• MalfunctionSep 13, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 71, 75 AND 73MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 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 03/31/2019 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 7873679 ↗
• MalfunctionSep 11, 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. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. THE E-3 ERROR OCCURRED AS SOON AS THE TEST STRIP WAS INSERTED INTO THE METER. CUSTOMER HAD LEFT THE TEST STRIP OUT OF THE VIAL TOO LONG AND THE TEST STRIP VIAL OPEN. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF 104 MG/DL. CUSTOMER HAD USED A NEW VIAL OF TEST STRIPS, SAME LOT NUMBER. CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT DISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING WEAK AND BELIEVED HER BLOOD SUGAR WAS LOW. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Weakness

  MAUDE report 7863826 ↗
• MalfunctionSep 6, 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 HI DISPLAY ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE REPORT SYMPTOMS OF EXCESSIVE THIRST, FREQUENT URINATION, SLEEPY, OFTEN HUNGRY, 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 BY CUSTOMER AND PRODUCED TEST RESULTS OF 585MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/27/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. INSTRUCTED CUSTOMER TO GO TO THE HOSPITAL. CUSTOMER STATES HE WILL GO TO THE HOSPITAL. CUSTOMER CANNOT CONTINUE THE TROUBLESHOOTING.

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

  MAUDE report 7852922 ↗
• MalfunctionAug 31, 2018Battery Problem; Battery Problem

  THE DAUGHTER CALLED AND STATED THAT THE METER DOESN'T TURN ON. AT THE TIME OF THE CALL A NEW BATTERY WAS INSERTED AND THE METER TURN ON. CUSTOMER'S DAUGHTER ALSO STATES THAT THE METER WAS NOT WORKING SINCE SHE RAN BACK TO BACK TESTS AND THE RESULTS WERE 365, 366,71 THEN ERRORS AND SHUT OFF, SHE DON'T REMEMBER THE ERROR CODES. THEY TESTED 4 TIMES BUT WAS NOT STATED IF CUSTOMER WAS FASTING AT THE TIME OR USING SAME HAND, DIFFERENT FINGER. THE TEST STRIPS ARE STORED IN THE KITCHEN CABINET (IMPROPER STORAGE). DAUGHTER INFORMED THAT CUSTOMER HAS CIRRHOSIS OF THE LIVER AND IF HER BLOOD SUGAR IS BELOW 80 MG/DL OR ABOVE 120 MG/DL SHE HAS TO BE TAKEN TO THE EMERGENCY ROOM, HOWEVER PATIENT WAS NOT TAKEN TO THE HOSPITAL THAT DAY. DAUGHTER HAD PURCHASED ANOTHER METER FROM THE PHARMACY, HAD TESTED HER MOM AND GOT 97 MG/DL. THE RESULT IS WITHIN THE CUSTOMER'S RANGE. DAUGHTER ALSO MENTIONED THAT CUSTOMER HAS DEMENTIA AND HAS HAD IT FOR MANY YEARS. CUSTOMER WAS GIVEN THE WRONG MEDICATION CAUSING HER DIABETES AND HER LIVER TO FAIL. ON THE DAY OF THE CALL THE CUSTOMER WAS FEELING WELL IN REGARDS TO HER DIABETES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838174 ↗
• MalfunctionAug 15, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON OF 42 MG/DL USING TRUEMETRIX METER AND 80 MG/DL USING ANOTHER DEVICE; CUSTOMER IS ALSO CONCERNED WITH RESULTS OBTAINED OF 65, 84, 51 AND 69 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 120 MG/DL. CUSTOMER STATED THAT THE RESULT OF 42 MG/DL WAS NOT IN THE METER MEMORY AS THE METER IS ALSO NOT STORING THE RESULTS. 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 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER SAYS THAT RESULT IS NOT IN METER MEMORY BECAUSE METER IS ALSO NOT STORING RESULTS. CUSTOMER SAYS HE RAN CONTROLS BEFORE CALLING AND RESULTS WERE WITHIN RANGE BUT IS STILL UNSATISFIED WITH THE METER. CUSTOMER DECLINED A REPLACEMENT METER. CUSTOMER CALLED BACK ON (B)(65) 2018 AND REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE RESULT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7784619 ↗
• MalfunctionAug 13, 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 BLOOD AND HIGH CONTROL GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH BLOOD TEST RESULTS OBTAINED OF 291, 274, 234, 205 AND 265 MG/DL AND WITH CONTROL TEST RESULTS OBTAINED OF 188 AND 185 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. 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 LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/27/2019 AND OPEN VIAL DATE IS JUNE 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7778450 ↗
• MalfunctionAug 13, 2018Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT OF PAST ADVERSE EVENT DUE TO E-5 ERROR, TEST STRIP ERROR, WHICH HAD OCCURRED AFTER THE BLOOD SAMPLE WAS ABSORBED. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 350MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. SISTER HAD STATED THAT AFTER CUSTOMER'S ROUTINE DIALYSIS TREATMENT ON (B)(6) 2018, CUSTOMER HAD PERFORMED BLOOD TESTS USING THE TRUEMETRIX METER AND OBTAINED RESULTS OF E-5, E-0 AND E-5. CUSTOMER HAD BEEN CONCERNED THAT THE METER WAS READING TOO HIGH DUE TO THE E-5 RESULTS. DUE TO THE E-5 RESULTS, CUSTOMER HAD TAKEN 7 UNITS OF FAST ACTING INSULIN. CUSTOMER HAD THEN BEGUN TO FEEL COLD, CLAMMY AND HAD GONE INTO CONVULSIONS. CUSTOMER'S SISTER HAD TAKEN HIM TO THE EMERGENCY ROOM. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL WAS "REALLY LOW", CUSTOMER DID NOT GET THE EXACT RESULT FROM THE DOCTORS. THE DIAGNOSIS WAS HYPOGLYCEMIA AND CUSTOMER RECEIVED IV MEDICATIONS; CUSTOMER WAS NOT SURE WHICH MEDICATIONS WERE ADMINISTERED. CUSTOMER WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY, (B)(6) 2018 WHEN HIS BLOOD GLUCOSE TEST RESULT WA

  Patient problems: Convulsion, Clonic; Hypoglycemia

  MAUDE report 7778156 ↗
• MalfunctionAug 10, 2018High 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 180 AND 182 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 160 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 06/30/2019 AND OPEN VIAL DATE IS JULY 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772702 ↗