TRUE METRIX sunmark TRUE METRIX SELF MONITORING BLOOD GLUCOSE METERRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00010939719447), received between Dec 1, 2016 and Jan 10, 2019 — classified as 61 malfunctions.

The most frequently reported specific device problem is “High Test Results” (36 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 44 AND 67 MG/DL. CUSTOMER STATED HE DID NOT HAVE ANY SYMPTOMS WHEN HE HAD OBTAINED THE 44 MG/DL FASTING. CUSTOMER WAS ALSO CONCERNED WITH ERRATIC RESULTS HE STATED BEGAN ABOUT TWO WEEKS AGO WHEN HE STARTED TO USE THIS VIAL OF TEST STRIPS; NO BACK-TO-BACK ERRATIC BLOOD GLUCOSE TEST RESULTS WERE REPORTED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 100 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2020, AND OPEN VIAL DATE IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERN BECAUSE HE RAN A TEST AND GOT 44MG/DL FASTING AND HE WAS NOT HAVING ANY SYMPTOMS AT ALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8232809 ↗
• MalfunctionNov 21, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR: SAMPLE NOT DETECTED OR USING WRONG TEST STRIP. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE E-2 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. CUSTOMER WAS USING THE CORRECT TEST STRIPS FOR THE METER. DURING THE CALL, BACK TO BACK BLOOD TESTS WERE PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-2 AND E-2 USING TRUEMETRIX METER. AT THE TIME OF THE CALL, CUSTOMER'S WIFE REPORTED CUSTOMER WAS FREQUENTLY THIRSTY, HAD BLURRY VISION, FREQUENT URINATION, FELT WEAK AND WAS HUNGRY. CUSTOMER WAS ADVISED TO SEEK MEDICAL ATTENTION. CUSTOMER WAS UNABLE TO CONTINUE WITH THE TROUBLESHOOTING PROCESS AND NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. AT CALL BACK ON (B)(6) 2018, THE CUSTOMER'S CONDITION HAD IMPROVED AND HE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2018 HE HAD GONE TO THE EYE DOCTOR AND THAT HIS VISION IS NO LONGER BLURRY. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE DOCTOR'S OFFICE WAS 190 MG/DL AND THE DOCTOR TOLD CUSTOMER TO TAKE HIS INSULIN. THE CUSTOMER WAS ALSO ABLE TO CONTINUE WITH THE TROUBLESHOOTING PROCESS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. T

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

  MAUDE report 8094952 ↗
• MalfunctionNov 5, 2018Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE E-3 ERROR OCCURRED AFTER THE BLOOD SAMPLE WAS APPLIED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING SLIGHTLY DIZZY AND SLEEPY. 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 NON-FASTING AND PRODUCED TEST RESULTS OF 100 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE DESK. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2019; CUSTOMER JUST STARTED TO USE THE TRUEMETRIX METER AND STRIPS ON DAY OF CALL.

  Patient problems: Dizziness; Fatigue

  MAUDE report 8039025 ↗
• MalfunctionOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR ERRATIC ACCOMPANIED WITH SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-120MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF HAVING A RASH. 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 BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 456 AND 501MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER IS CONCERNED THAT READINGS ARE ERRATIC AND HIGH BUT DOESN'T BELIEVE THEY SHOULD BE THIS HIGH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7978316 ↗
• MalfunctionSep 27, 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 50 AND 52 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 102 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 94 MG/DL AND 96 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 03/19/2020 AND OPEN VIAL DATE IS (B)(6) 2018. 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 7915603 ↗
• MalfunctionSep 10, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HI AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI AND 34 MG/DL. THE RESULT OF 34 MG/DL WAS OBTAINED EARLY IN THE MORNING AND CUSTOMER STATED SHE TAKES HER LANTUS AT THE SAME TIME EVERY NIGHT AND HER GLUCOSE SHOULD NOT HAVE READ SO LOW. CUSTOMER IS ALSO CONCERNED WITH RESULT OBTAINED OF 274 MG/DL OBTAINED MORNING OF CALL AS SHE HAD EATEN PEANUT BUTTER CRACKERS HOURS BEFORE TEST IN ORDER TO INCREASE HER GLUCOSE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 225 - 250 MG/DL. CUSTOMER STATED SHE HAD SOME STRESS THAT MORNING THAT COULD HAVE CAUSED HER GLUCOSE TO ELEVATE BUT NOT TO HI. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7862183 ↗
• MalfunctionAug 21, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. GRANDMOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL OF THE LOW RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. NO MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. 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 10/13/2019 AND OPEN VIAL DATE IS 7/25/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER WAS ADVISED BY THE PHARMACIST TO TAKE THE METER TO THE HOSPITAL SO THAT THEY CAN TEST IT FOR HER, SO SHE DID. CONTACT THE CUSTOMER AND CUSTOMER STATES THAT SHE TOOK THE METER TO THE HOSPITAL AND THEY TOLD HER THAT THE METER IS GIVING THE 40-60 POINTS LOWER. CUSTOMER HAVE ONLY BEEN USING THE METER FOR TWO DAYS NOW. CUSTOMER STATE THAT THE METER HAS BEEN GIVING LOW RESULTS IN THE 60'S MG/DL. HER GRANDDAUGHTER HAS NOT BEEN HAVING ANY SYMPTOMS PERTAINING TO HER BLOOD SUGAR. THEY RAN HER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802670 ↗
• MalfunctionAug 9, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 39, 40 AND 64 MG/DL; RESULTS OF 39 AND 40 MG/DL COULD NOT BE CONFIRMED IN THE METER MEMORY. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 130 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 212 MG/DL AND 221 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 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 7769022 ↗
• MalfunctionJul 24, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. CUSTOMER WAS ALSO CONCERNED WITH HIGH RESULTS OBTAINED OF 504 AND 399 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 300 - 350 MG/DL. CUSTOMER STATED HIS BLOOD SUGAR NORMALLY RUNS HIGH. 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 487 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/23/2018; TEST STRIPS ARE EXPIRED AT TIME OF CALL. OPEN VIAL DATE IS ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:HI 205P(B)(6) FASTING; RESULT 2:504MG/DL 123P (B)(6) FASTING; RESULT 3:253MG/DL 4:31P (B)(6) FASTING; RESULT 4:321MG/DL 153P (B)(6) FASTING; RESULT 5:399MG/DL 800P (B)(6) FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716117 ↗
• MalfunctionJul 23, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 -105 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 STORAGE LOCATION IS UNDISCLOSED 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 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER STATES WHILE RUNNING MULTIPLE TESTS ON THIS METER THEY WERE GIVEN A RESULT OF LO AND NOT AN ACTUAL NUMBER AND IS NOT READING ACCURATELY. CUSTOMER STATES THEY ARE NOT COMFORTABLE WITH THIS METER DUE TO THE RESULTS BECAUSE SHE WAS NOT FEELING SYMPTOMS OF LOW BLOOD SUGAR AND WOULD LIKE IT REPLACED. CUSTOMER IS NON-FASTING, CANNOT PERFORM BACK TO BACK TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7711796 ↗
• MalfunctionJul 17, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH METER TO METER COMPARISON OF 172MG/DL USING THE TRUE METRIX AND 498MG/DL WITH THE HOSPITAL METER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120MG/DL OR UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY AND HAVING A HEADACHE. 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/16/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER WAS AT HOME AND WAS HAVING SYMPTOMS OF HIGH BLOOD SUGAR. HE TOOK A BLOOD TEST ON THE TRUE METRIX AT 4:31AM ON (B)(\6) 2018 AND IT READ 172MG/DL FASTING. RIGHT AWAY HIS WIFE TOOK HIM TO THE HOSPITAL (WHICH WAS 5 MINUTES AWAY) AND THE HOSPITAL METER WAS 498MG/DL. THE CUSTOMER STAYED FOR 6 HOURS WHERE THEY CHECKED HIS BLOOD SUGAR EVERY 30 MINUTES AND LEFT THE SAME DAY. NO CHANGES IN MEDICATION OR DIET. HIS BLOOD RESULT, WHEN HE LEFT ON (B)(6) 2018, WAS 350MG/DL. HE WA

  Patient problems: Dizziness; Headache

  MAUDE report 7693887 ↗
• MalfunctionJul 16, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF LO. CUSTOMER STATED THAT WHEN SHE OBTAINED THE LO RESULT, SHE WAS FEELING DIZZY AND SHE HAD DRANK A HALF OF A CAN OF SODA AND SHE HAD FELT BETTER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 120 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING A LITTLE DIZZY; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER ATTEMPTED TO PERFORM BLOOD TEST DURING THE CALL ON (B)(6) 2018, BUT WAS UNABLE TO OBTAIN A RESULT DESPITE THREE ATTEMPTS. CUSTOMER IS STORING THE PRODUCT IN HER POCKETBOOK WHICH SHE TAKES WITH HER WHEN SHE LEAVES THE HOME. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/26/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Dizziness

  MAUDE report 7689992 ↗
• MalfunctionJun 1, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 92MG/DL (NON FASTING). THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 129 TO 140MG/DL OR 170 TO 180MG/DL NON-FASTING. THE CUSTOMER DID REPORT SYMPTOMS OF TINGLING FEET AND FEELING LIGHTHEADED. 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 NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 99 AND 97MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/21/2019 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: Dizziness; Tingling

  MAUDE report 7562567 ↗
• MalfunctionMay 18, 2018High Test Results; High Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR E-3 ERROR. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 475 MG/DL USING TRUEMETRIX METER. CUSTOMER WAS ASKED ABOUT THE RESULT AND CUSTOMER THEN STATED THAT THE METER HAD PREVIOUSLY READ HI. A SECOND BLOOD TEST WAS NOT PERFORMED, CUSTOMER WAS NOT FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 -130 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/17/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (CUSTOMER IS NOT CONCERNED WITH ANY OF THE RESULTS): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7525496 ↗
• MalfunctionMay 8, 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 140MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY ON (B)(6) 2018. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS.THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN ANOTHER CONTAINER. CUSTOMER STATES THAT HE REMOVE THE STRIPS AND PLACE THEM IN A CONTAINER SO THAT HE CAN EASILY GET TO THEM. THE TEST STRIP MANUFACTURER'S EXPIRATION DATE IS UNDISCLOSED AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER DID NOT WANT TO GO INTO THE METERS MEMORY TO PROVIDE THE RESULTS BECAUSE HE IS OLD AND HE SHOULD NOT HAVE TO GO THROUGH ALL OF THIS TO GET A REPLACEMENT METER. CUSTOMER WENT TO THE DOCTOR ON (B)(6) 2018 BECAUSE HE WAS FEELING DIZZY AND HE THOUGHT SOMETHING WAS WRONG WITH HIM. CUSTOMER STATES HE IS (B)(6) AND HE DOES NOT WANT TO FALL AND BECAUSE OF HIS DIABETES. CUSTOMER STATES THAT THEY GAVE HIM A WELLNESS EVALUATION BUT WAS NOT GIVEN HIS DIAGNOSIS. CUSTOMER STATES THAT HE HAVE BEEN GETTIN

  Patient problems: Dizziness

  MAUDE report 7494144 ↗
• MalfunctionApr 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 329, 301, 291, 277 AND 218 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 - 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 BOTH IN THE KITCHEN AND FAMILY ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/22/2019 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 7472653 ↗
• MalfunctionApr 24, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 RESULT THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER DIDN'T HAVE SYMPTOMS AT THE TIME OF THE CALL. THE CUSTOMER DID REPORT BEING FOUND UNCONSCIOUS ON A PREVIOUS OCCASION. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE REPORTED EVENT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/18/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. ON THE PREVIOUS EVENT, CUSTOMER WAS FOUND UNCONSCIOUS BY A FAMILY MEMBER AND WAS TRANSPORTED TO THE HOSPITAL VIA 911. CUSTOMER WOKE UP A FEW DAYS LATER. CUSTOMER STATES HE HAD SEVERAL BROKEN RIBS BECAUSE OF CPR CONDUCTED. APPARENTLY, THE CUSTOMER HAD A HEART ATTACK AS WELL. MEDICAL INTERVENTION WAS REQUIRED BUT CUSTOMER IS NOT SURE IF IT WAS BECAUSE HE WAS HOSPITALIZED BECAUSE OF HYPERGLYCEMIA OR HIS HEART ATTACK. HE DOES NOT REMEMBER MUCH ABOUT THE DATES AND TIME. CUSTOMER DID NOT DISCLOSE WHEN ADMITTED TO HOSPITAL BUT STATED THEY HAD HIGH BLOOD GLUCOSE LEVELS AT HOSPITAL OF 1000MG/DL (UNKNOWN IF FASTING OR NON-FASTI

  Patient problems: Hyperglycemia; Loss of consciousness

  MAUDE report 7455831 ↗
• MalfunctionApr 10, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 298, 341, 298, 228 AND 262 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, 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 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2018. 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 7411983 ↗
• MalfunctionApr 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. CUSTOMER WANTS TO KNOW WHAT HI MEANS. SPOUSE IS CALLING ON BEHALF OF THE CUSTOMER. 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 NOT PERFORMED THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 3/28/2019 AND OPEN VIAL DATE IS (B)(6) 2018 (TODAY). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: HI DATE: (B)(6) 2018. TIME: 4:59 PM. ONLY ONE TEST PERFORMED ON THE METER. CUSTOMER DOES NOT REGULARLY TEST SO THERE ARE NO EXPECTED RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7399613 ↗
• MalfunctionMar 28, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 151, 130 151 AND 161MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 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 11/30/2018 AND OPEN VIAL DATE IS ABOUT 1 WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER CALLED ABOUT METER READING HIGH BLOOD RESULTS- THERE WAS A WIDE VARIANCE BETWEEN THE HIGH RESULTS AND THE THEN NEXT RESULTS. CUSTOMER CLAIMS THE METER READ 210MG/DL AND THEN 120MG/DL ON THE NEXT BLOOD RESULTS. I COULD NOT VERIFY THOSE RESULTS IN THE MEMORY. CUSTOMER DID NOT VERIFY IF THE RESULTS OF 210MG/DL AND 120MG/DL WERE FASTING OR NON-FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7378445 ↗
• MalfunctionMar 23, 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 210, 182, 181, 189, 249 AND 250 MG/DL. 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :210MG/DL DATE: (B)(6) 2018 TIME:09:10AM FASTING; RESULT 2 :182MG/DL DATE: (B)(6) 2018 TIME:07:37AM FASTING; RESULT 3 :167MG/DL DATE: (B)(6) 2018 TIME:06:04AM FASTING; RESULT 4 :181MG/DL DATE: (B)(6) 2018 TIME:06:47AM FASTING; RESULT 5 :189MG/DL DATE: (B)(6) 2018 TIME:12:30PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365453 ↗
• MalfunctionMar 20, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-0 BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION REPORTED FOR THE ACTUAL COMPLAINT. CUSTOMER MENTION THAT HAS ANEMIA.. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 113 MG/DL USING TRUE METRIX METER. CUSTOMER WAS ABLE TO OBTAIN A BLOOD GLUCOSE READING DURING THE TRAINING AT THE TIME OF THE CALL. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER ALSO MENTION THAT WAS HOSPITALIZED ON TWO DIFFERENT OCCASIONS. CUSTOMER STATES THAT ON (B)(6) 2018, HE WAS FEELING SICK, HE CHECKED HIS BLOOD SUGAR AND THE RESULTS WAS 305 MG/DL FASTING. CUSTOMER WENT TO THE ER, AT THE ER, HIS BLOOD SUGAR WAS 205 MG/DL FASTING. CUSTOMER WAS DIAGNOSED WITH DKA, HE RECEIVED IV FLUIDS, MONITORED OVER NIGHT AND WAS RELEASED ON (B)(6) 2018 MG/DL THERE WERE NO NEW RECOMMENDATIONS OR CHANGES TO TREATMENT PLAN. ON (B)(6) 2018 CUSTOMER HAD AN UL

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 7355594 ↗
• MalfunctionFeb 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 OF 180MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER STATED SHE WAS AT WORK AND DID NOT HAVE TIME. 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 JANUARY 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304557 ↗
• MalfunctionFeb 20, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH METER TO METER COMPARISON OF 68 MG/DL USING TRUE METRIX METER VS 51 MG/DL USING ANOTHER METER AND A RESULTS OF 198 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING HUNGRY AND DIZZY UPON STANDING. 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 04/30/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT THE DOCTOR CHANGE HIS INSULIN FROM LEVEMIR TO TRISABEA ON (B)(6) 2018. CUSTOMER IS NOW FEELING HUNGRY, AND IF HE STANDS UP, HE FEELS DIZZY.

  Patient problems: Dizziness

  MAUDE report 7283476 ↗
• MalfunctionFeb 1, 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 264 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 89-120 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) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 238 MG/DL AND 278 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE IS DECEMBER 2017. 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 7233944 ↗