TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter – FREE METER ONLYRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00096295126655), received between Dec 1, 2016 and Nov 19, 2018 — classified as 43 malfunctions.

The most frequently reported specific device problem is “High Test Results” (26 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 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-2 ACCOMPANIED BY SYMPTOMS. BROTHER IS CALLING FOR CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING VERY LETHARGIC AND HIS HEAD FEELS HEAVY. 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. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULT OF 127MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2019 AND OPEN VIAL DATE IS ONE WEEK AGO.THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER STATES THAT HE FEELS VERY LETHARGIC AND HIS HEAD FEELS HEAVY. NO MEDICAL ATTENTION NEEDED AT THIS TIME. GETTING E2 ERROR MESSAGE WHEN THE BLOOD SAMPLE IS ABSORBED.

  Patient problems: Lethargy

  MAUDE report 8084175 ↗
• MalfunctionOct 9, 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 AND ERRATIC BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 140, 137, 121, 333 AND 124 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 127 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/30/2019 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 7949600 ↗
• MalfunctionAug 14, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 286, 234, 253, AND 284 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 250 MG/DL. CUSTOMER HAD NOT BEEN USING THE CORRECT TESTING TECHNIQUE FOR BACK TO BACK TESTS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE IS A FEW DAYS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 112 MG/DL AND 121 MG/DL USING TRUEMETRIX METER. CUSTOMER HAD OPENED A NEW VIAL OF TEST STRIPS TO PERFORM BACK TO BACK BLOOD TEST DURING CALL; THE LOT NUMBER WAS NOT PROVIDED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER WAS NOT DOING THE PROPER BACK TO BACK TECHNIQUE. CUSTOMER WAS TESTING SAME HAND, SAME FINGER. CUSTOMER IS ALSO STORING STRIPS IMPROPERLY IN KITCHEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782536 ↗
• MalfunctionAug 13, 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 303, 292, 441 AND 290 MG/DL NON-FASTING AND 292 AND 134 MG/DL FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 130 MG/DL; AN EXPECTED NON-FASTING RANGE WAS NOT PROVIDED. AT THE TIME OF THE CALL, THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED SHE HAD BEEN CONCERNED WHEN SHE HAD OBTAINED THE RESULT OF 441 MG/DL NON-FASTING ON (B)(6) 2018 AND THAT SHE HAD GONE TO THE EMERGENCY ROOM. CUSTOMER DID NOT REPORT SHE HAD BEEN EXPERIENCING ANY SYMPTOMS. AT THE HOSPITAL, THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WAS 232 MG/DL NON-FASTING. THE DIAGNOSIS WAS HYPERGLYCEMIA. THE CUSTOMER DID NOT STATE THAT SHE RECEIVED ANY TREATMENT. THE CUSTOMER LEFT THE HOSPITAL THE SAME DAY. NO NEW MEDICATIONS OR HEALTHCARE PROGRAM HAD BEEN SUGGESTED. CUSTOMER CONTINUED TO USE THE TRUEMETRIX METER. 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; OPENED VIALS ARE STORED IN THE LIVING ROOM AND UNOPENED VIALS IN THE BEDROOM CLOSET.

  Patient problems: Hyperglycemia

  MAUDE report 7779090 ↗
• MalfunctionAug 3, 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 BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. AT THE TIME OF THE CALL THE CUSTOMER STATED HE WAS SHAKY, DRINKING A LOT, URINATING A LOT AND HAD EXCESSIVE HUNGER. CUSTOMER STATED HE WOULD HAVE A FAMILY MEMBER TAKE HIM TO THE HOSPITAL. CUSTOMER COULD NOT CONTINUE WITH THE TROUBLESHOOTING PROCESS AND NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Polydipsia; Shaking/Tremors; Urinary Frequency / Polyuria

  MAUDE report 7748224 ↗
• MalfunctionJul 23, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR: SAMPLE NOT DETECTED OR USING WRONG TEST STRIP. THE E-2 ERROR OCCURRED AFTER THE BLOOD SAMPLE WAS APPLIED. AT THE TIME OF THE CALL THE CUSTOMER STATED SHE HAD DISTORTED VISION; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER IS USING CORRECT TEST STRIPS AND PRODUCT IS STORED ACCORDING TO THE SPECIFICATION. DURING THE CALL ON (B)(6) 2018 A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-2 ERROR USING TRUEMETRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2019 AND OPEN VIAL DATE IS (B)(6) 2018.

  Patient problems: Blurred Vision

  MAUDE report 7711718 ↗
• MalfunctionJul 5, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER NOT FEELING WELL. 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 11/17/2018 AND OPEN VIAL DATE IS MORE THAN FOUR MONTHS AGO. TEST STRIPS ARE EXPIRED BASED ON OPEN DATE. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. METER READ E-3. CUSTOMER IS NOT FEELING WELL. CUSTOMER DID NOT PROVIDE INFORMATION WHETHER SHE IS NOT FEELING WELL DUE TO HER DIABETES. CUSTOMER DID NOT HAVE ANOTHER VIAL OF STRIPS.

  Patient problems: No Information

  MAUDE report 7663808 ↗
• MalfunctionJun 13, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR MULTIPLE ERROR MESSAGES ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 180 TO 187MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF CONFUSION, NERVOUSNESS, SWEATINESS, MOOD SWINGS, SLURRED SPEECH. 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 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 06/14/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED IN AND STATES THAT THE METER IS GIVING MULTIPLE ERRORS MESSAGES. CUSTOMER IS NOT SURE WHAT THE ERROR MESSAGES WERE. CUSTOMER WASTED SEVERAL STRIPS TRYING TO RUN A BLOOD TEST. CUSTOMER IS CURRENTLY HAVING ANY SYMPTOMS PERTAINING TO DIABETES AT THIS TIME SUC AS CONFUSION, NERVOUSNESS, SWEATINESS, MOOD SWINGS, SLURRED SPEECH. CUSTOMER'S NORMAL FASTING RANGE180MG/DL-187MG/DL FASTING. VERIFIED CUSTOMER IS STORING THE STRIPS PROPERLY IN LIVING ROOM. CUSTOMER DECLINED TO GO THROUGH THE PROPER TECHNIQU

  Patient problems: Anxiety; Confusion/ Disorientation; Sweating

  MAUDE report 7598645 ↗
• MalfunctionMay 25, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF FEELING LIGHTHEADED. 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 LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 161 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/14/2019 AND OPEN VIAL DATE IS (B)(6) 2018 (TODAY). THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness

  MAUDE report 7544553 ↗
• MalfunctionMay 7, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 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. CUSTOMER WAS UNABLE TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/14/2019 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 7492413 ↗
• MalfunctionMar 6, 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 AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 262, 186, 42, 83 AND 196 MG/DL; RESULTS OF 262 AND 42 MG/DL WERE REPORTED AS BEING PERFORMED NON-FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90- 130 MG/DL; AN EXPECTED NON-FASTING RANGE WAS NOT PROVIDED. CUSTOMER WAS COMPARING RESULTS FROM ANOTHER DEVICE AND STATED THE OTHER DEVICE READ ABOUT 100 POINTS LOWER; 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/17/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER SAYS METER IS READING INCORRECT. SAYS SOMETIMES IT READS TOO HIGH AND SOMETIMES IT READS TOO LOW. CUSTOMER IS MORE CONCERNED OF A LOW RESULT SHE GOT THE OTHER DAY OF 42 MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7317804 ↗
• MalfunctionMar 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI, 478, 524, 501 AND 596 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/18/2018 AND OPEN VIAL DATE IS (B)(6) 2017. BASED ON STRIP OPEN DATE PROVIDED OF (B)(6) 2017, CUSTOMER'S TEST STRIPS ARE EXPIRED - AT THE TIME OF THE CALL THEY ARE FOUR MONTHS PAST THE DATE FIRST OPENED. CUSTOMER HAD A NEW VIAL OF TEST STRIPS, LOT# MU2564, MANUFACTURER'S EXPIRATION DATE OF 01/28/2019. BLOOD TEST PERFORMED DURING THE CALL ON (B)(6) 2018 WITH THIS NEW VIAL OF TEST STRIPS PRODUCED TEST RESULT OF 483 MG/DL NON-FASTING USING TRUEMETRIX METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7307241 ↗
• MalfunctionFeb 12, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 222 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 180 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 136 MG/DL AND 134 MG/DL USING TRUEMETRIX METER. 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 7263292 ↗
• MalfunctionFeb 9, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI AND 166, 168, 214 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70-160 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 592 MG/DL AND HI USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/23/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING HI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260948 ↗
• MalfunctionFeb 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 284 AND 144 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 130 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. 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 2/14/2019 AND OPEN VIAL DATE IS APPROXIMATELY ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CALLER DOES NOT BELIEVE A READING CAN GO FROM 284 MG/DL TO 169 MG/DL TO 144 MG/DL IN UNDER FOUR MINUTES. CUSTOMER CALLED IN FOR A REPLACEMENT OF METER BECAUSE OF ERRATIC RESULTS OBTAINED ON METER. THE TEST STRIP VIAL WAS OPENED LESS THAN A MONTH AGO AND ARE BEING STORED IN THE KITCHEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7249296 ↗
• MalfunctionDec 19, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130-200 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2017, A 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 02/15/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING HIGH. THE CUSTOMER STATES THAT SUGAR USUALLY RUNS HIGH AND THAT HE HAS NO SYMPTOMS. CUSTOMER ORIGINALLY CALLED IN STATED METER DISPLAYED E5, AFTER TROUBLE SHOOTING, METER DISPLAYED HI. CUSTOMER NORMAL BLOOD SUGAR FASTING 130-200 MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130911 ↗
• MalfunctionOct 30, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED RESULTS OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 TO 150MG/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 11/24/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 82MG/DL DATE: (B)(6) 2017 TIME: 8:14AM FASTING. RESULT 2 : 285MG/DL DATE: (B)(6) 2017 TIME: 5:17AM FASTING. RESULT 3 : 551MG/DL DATE: (B)(6) 2017 TIME: 2:18PM FASTING. RESULT 4 : HI DATE: (B)(6) 2017 TIME: 12:23PM FASTING. RESULT 5 : HI DATE: (B)(6) 2017 TIME: 10:13PM FASTING. CUSTOMER CALLED ABOUT E-5, WHILE EXPLAINING THAT IT MAY BE A HIGH BLOOD SUGAR READING (OVER 600MG/DL) CUSTOMER MENTIONED THAT SHE ALSO OBTAINED AN HI. CUSTOMER FEELS FINE AND DENIES SYMPTOMS RELATED TO DIABETES AT THE TIME OF CALL. CUSTOMER STATES HER LAST A1C WAS 7.3 (163MG/DL) AND THAT HER FASTING RANGE IS 110-150MG/DL. CUSTOMER IS N

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6988306 ↗
• MalfunctionAug 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR E-0 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY. 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, A BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 168MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/14/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness

  MAUDE report 6824822 ↗
• MalfunctionAug 18, 2017High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER INITIALLY REPORTED COMPLAINT FOR E-0: INVALID HEMATOCRIT. THE E-0 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF HI AND 568 MG/DL USING TRUEMETRIX METER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI AND 568 MG/DL. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING TIRED, FATIGUED AND HAVING INCREASED THIRST. THE CUSTOMER DECLINED ANY MEDICAL ATTENTION AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE IS 07/26/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 568MG/DL, (B)(6) 2017, 12:34:00 PM, FASTING: NO; HI, (B)(6) 2099, 12:30:00 PM, FASTING:NO; MEMORY CONCERNS:568 MG/DL, NOT FASTING, HI.

  Patient problems: Fatigue; Polydipsia

  MAUDE report 6805603 ↗
• MalfunctionAug 16, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE E-3 ERROR OCCURRED AFTER THE BLOOD SAMPLE IS APPLIED. THE CUSTOMER DID REMOVE THE STRIPS FROM THE ORIGINAL VIAL AND PLACED THEM IN ANOTHER CONTAINER FOR THE EASE OF CARRYING THEM AROUND. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED HAVING FREQUENT URINATION AND FEELING DIZZY FOR THE PAST TWO-THREE MONTHS. CUSTOMER STATED THAT HER DOCTOR IS AWARE OF HER SYMPTOMS. CUSTOMER DECLINED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. THE CUSTOMER DECLINED TO PERFORM A BLOOD TEST DURING THE CALL ON (B)(6) 2017. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE CLOSET. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/16/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Urinary Frequency / Polyuria

  MAUDE report 6797015 ↗
• MalfunctionAug 14, 2017Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT OF DEAD METER. CUSTOMER WOULD INSERT A TEST STRIP AND THE METER WOULD NOT TURN ON. THE METER IS THREE MONTHS OLD AND THE BATTERY HAS NOT BEEN REPLACED. CUSTOMER STATED THAT SHE DID NOT SEE A LOW BATTERY SYMBOL. THE METER DID NOT TURN ON BY INSERTING A TEST STRIP. THE METER TURNED ON BY MANUALLY PRESSING THE WHITE DOT BUTTON. DURING THE CALL ON (B)(6)2017 THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6)2017 AS A RESULT OF THE METER'S READINGS. A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER DURING THE CALL ON (B)(6)2017. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE AT TIME OF CALL WAS ABOUT A MONTH. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6)2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6791291 ↗
• MalfunctionAug 8, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULT OF 349 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99 TO 110 MG/DL. THE CUSTOMER 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 06/16/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6773526 ↗
• MalfunctionAug 1, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE RESULTS. A FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH THE RESULT OF LO. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120MG/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 BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/23/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY) (B)(6). THE CUSTOMER'S FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER WANTED TO KNOW WHAT LO MEANT. I INFORMED THE CUSTOMER THAT LO MEANS THAT THE RESULTS IS READING BELOW 20 MG/DL. I VERIFIED AND CONFIRMED WITH THE CUSTOMER THAT SHE IS NOT EXPERIENCING ANY SYMPTOMS REGARDING HER DIABETES AND DOES NOT NEED TO SEEK ANY MEDICAL ATTENTION. THE CUSTOMER IS STORING THE METER AND TEST STRIPS IN THE LIVING ROOM. THE CUSTOMER DOES NOT WANT TO PERFORM A BACK TO BACK BLOOD TEST DUE TO WASTING TOO MANY TEST STRIPS BECAUSE OF THE LO RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6757220 ↗
• MalfunctionJul 25, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. GRANDMOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE E-5 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL THE CUSTOMER WAS FEELING NAUSEATED AND WAS THROWING UP IN THE BATHROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/20/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. GRANDMOTHER HAD DISCONNECTED THE CALL.

  Patient problems: Nausea; Vomiting

  MAUDE report 6742033 ↗
• MalfunctionJul 20, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE E-3 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 215 MG/DL. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER REPORTED FEELING HUNGRY, BODY FEELING WARM AND FEELING DRY MOUTH. CUSTOMER DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 231 MG/DL USING TRUEMETRIX METER. CUSTOMER WAS COMFORTABLE WITH THE RESULT. CUSTOMER STORES STRIPS IN THE BASEMENT. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/14/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperthermia; No Code Available

  MAUDE report 6727838 ↗