TRUE METRIX PRO TRUE METRIX PRO BLOOD GLUCOSE TEST STRIPS - 50 Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00021292007867), received between Dec 1, 2016 and Jun 27, 2024 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS USING TRUE METRIX PRO METER AND TEST STRIPS WHICH IS FOR MULTIPLE PATIENT USE. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 59, 63, 49 AND 65 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-95 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 DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/20/2025 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 59 MG/DL , DATE: ON (B)(6) 2024 , TIME: 4:42 AM FASTING. RESULT 2: 63 MG/DL, DATE: ON (B)(6) 2024 , TIME: 11:29 AM FASTING . RESULT 3: 82 MG/DL, DATE: ON (B)(6) 2024 , TIME: 8:13 AM FASTING . RESULT 4: 49 MG/DL, DATE: ON (B)(6) 2024 , TIME: 5:28 AM FASTING. RESULT 5: 65 MG/DL , DATE: ON (B)(6) 2024 , TIME: 5:27 AM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19626090 ↗
• MalfunctionFeb 15, 2024Low 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 50 AND 60 MG/DL. 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN A HALL CLOSET. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/22/2024 AND TEST STRIPS WERE OPENED 2 WEEKS PRIOR TO CALL. THE CUSTOMER IS USING THE TRUE METRIX PRO METER/STRIPS (MULTI-PATIENT USE); REPLACEMENT TRUE METRIX SYSTEM WAS SENT TO CUSTOMER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 3 RESULTS PROVIDED): RESULT 1: 50 MG/DL DATE: (B)(6) 2024 TIME: 9:25 AM FASTING. RESULT 2: 50 MG/DL DATE:(B)(6) 2024 TIME: 9:24 AM FASTING. RESULT 3: 60 MG/DL DATE: (B)(6) 2024 TIME: PM FASTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18713198 ↗
• MalfunctionNov 2, 2023Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGES (E-0, E-4 AND E-6) USING TWO DIFFERENT VIALS OF TEST STRIPS; INTERNAL REPORT REFERENCE (B)(4). CUSTOMER IS USING TRUE METRIX PRO PRODUCTS WHICH ARE DESIGNED FOR PROFESSIONAL USE. CUSTOMER STATED HE IS UNABLE TO DETERMINE WHICH RESULTS HE OBTAINED USING EACH VIAL. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 202, 223, 214 AND 250 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS <130 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140-160 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT DUE TO THE METER RESULTS AND ERROR MESSAGES HE HAD GONE THAT MORNING ( (B)(6) 2023) TO THE CLINIC (PHARMACY). CUSTOMER STATED THE PHARMACIST HAD ATTEMPTED TO ASSIST BUT HAD THEN ADVISED THE CUSTOMER TO CONTACT THE MANUFACTURER. DURING THE CALL, 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 11/22/2024 AND TEST STRIPS WERE OPENED 1-2 WEEKS PRIOR TO CALL. THE METER MEMORY WAS REV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055133 ↗
• MalfunctionNov 2, 2023Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Image Display Error/Artifact; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS AND ERROR MESSAGES (E-0, E-4 AND E-6) USING TWO DIFFERENT VIALS OF TEST STRIPS; INTERNAL REPORT REFERENCE (B)(4). CUSTOMER IS USING TRUE METRIX PRO PRODUCTS WHICH ARE DESIGNED FOR PROFESSIONAL USE. CUSTOMER STATED HE IS UNABLE TO DETERMINE WHICH RESULTS HE OBTAINED USING EACH VIAL. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 202, 223, 214 AND 250 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS <130 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140-160 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT DUE TO THE METER RESULTS AND ERROR MESSAGES HE HAD GONE THAT MORNING (B)(6) 2023 TO THE CLINIC (PHARMACY). CUSTOMER STATED THE PHARMACIST HAD ATTEMPTED TO ASSIST BUT HAD THEN ADVISED THE CUSTOMER TO CONTACT THE MANUFACTURER. DURING THE CALL, 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 03/31/2025 AND TEST STRIPS WERE OPENED 1-2 WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055047 ↗
• MalfunctionFeb 13, 2023High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 158, 157, 210, 189 AND 568 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE 80-130 MG/DL AM FASTING AND LESS THAN 180 MG/DL 2 HRS. AFTER MEAL. THE CUSTOMER IS USING TRUE METRIX PRO METER AND TRUE METRIX PRO TEST STRIPS. 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 06/13/2024 AND OPEN VIAL DATE IS TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368137 ↗
• InjuryMay 14, 2021Incorrect, 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 TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 279 AND 298 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH RESULTS OBTAINED OF 339 AND 285 MG/DL; TESTS WERE NOT PERFORMED BACK TO BACK. CUSTOMER WAS USING THE INCORRECT TEST STRIPS WITH THE TRUE METRIX METER; CUSTOMER WAS USING TRUE METRIX PRO TEST STRIPS. THE CUSTOMER DID NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. AT THE TIME OF THE INITIAL CALL, MEDICAL ATTENTION WAS 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 03/31/2022 AND OPEN VIAL DATE IS 04/05/2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Hyperglycemia

  MAUDE report 11826796 ↗
• InjuryJun 16, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR CODE. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUES AND WAS USING TRUEMETRIX PRO TEST STRIPS WITH TRUEMETRIX METER. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 112 MG/DL USING TRUEMETRIX METER. AFTER TROUBLESHOOTING, THE CUSTOMER IS SATISFIED THE PRODUCT IS WORKING AS INTENDED AND DECLINES A REPLACEMENT. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING AREA. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/25/2021 AND OPEN VIAL DATE IS 05/10/2020. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SLIGHT DIZZINESS, MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL.

  Patient problems: Dizziness

  MAUDE report 10159238 ↗
• InjuryFeb 3, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM FASTING RESULTS OBTAINED OF 190 AND 215 MG/DL AND FROM NON-FASTING RESULT OBTAINED OF 192 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 115 MG/DL AND NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 170 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER REPORTED PAST MEDICAL INTERVENTION THAT HAD OCCURRED ON (B)(6) 2018. CUSTOMER STATED AMBULANCE HAD BEEN CALLED AS HE HAD SYMPTOMS OF FATIGUE AND HAD PASSED OUT. CUSTOMER DID NOT DISCLOSE BLOOD GLUCOSE RESULTS OBTAINED AT THAT TIME USING THE METER. WHEN THE AMBULANCE HAD ARRIVED, CUSTOMER¿S BLOOD GLUCOSE RESULT WAS 269 MG/DL NON-FASTING. CUSTOMER WAS DIAGNOSED WITH DEHYDRATION AND HYPERGLYCEMIA AND AN IV WAS ADMINISTERED. CUSTOMER STATED HE WAS NOT HOSPITALIZED AND HIS BLOOD GLUCOSE TEST RESULT WHEN AMBULANCE LEFT WAS 150 MG/DL NON-FASTING. CUSTOMER WAS ADVISED TO FOLLOW-UP WITH HIS PRIMARY CARE PHYSICIAN AND HAD DONE SO ON 07/14/2018, WHERE HE HAD BEEN PRESCRIBED GLIPIZIDE. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9662088 ↗
• MalfunctionJan 23, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR CODE. NURSE IS CALLING ON BEHALF OF FACILITY. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. AT THE TIME THE E-5 ERROR WAS OBTAINED, NURSE STATED THE PATIENT HAD REPORTED SYMPTOMS OF NAUSEA, DIZZINESS AND FATIGUE. NURSE STATED THAT PRIOR TO HER CALLING, THE PATIENT'S SON HAD STATED HE WAS TAKING PATIENT TO THE EMERGENCY ROOM. PATIENT WAS NOT AVAILABLE AT TIME OF CALL. PROPER TESTING TECHNIQUE WAS NOT BEING USED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LABORATORY IN THE FACILITY. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/31/2020 AND OPEN VIAL DATE IS (B)(6) 2019.

  Patient problems: Dizziness; Fatigue; Nausea

  MAUDE report 9623316 ↗
• MalfunctionDec 4, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. (B)(6) IS CALLING ON BEHALF ON THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH THE TEST RESULTS FROM RESULTS OBTAINED IN THE 40'S AND 50'S. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BACK TO BACK TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURE'S EXPIRATION DATE IS 01/30/2021 AND THE OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412177 ↗
• InjuryOct 23, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR. THE E-2 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS APPLIED TO THE TEST STRIP. AT THE TIME OF THE CALL THE CUSTOMER WAS NOT FEELING WELL AND REPORTED SYMPTOMS OF FEELING VERY TIRED AND WEAK. MEDICAL ATTENTION WAS NOT REQUIRED AT THE TIME OF THE CALL. CALL WAS ESCALATED DUE TO SYMPTOMS; TECHNICIAN ATTEMPTED TO CALL CUSTOMER BUT WAS UNABLE TO REACH VIA TELEPHONE.

  Patient problems: Lethargy; Weakness

  MAUDE report 9226011 ↗
• MalfunctionOct 25, 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 269, 267, 204, 230 AND 148 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 130 MG/DL. CUSTOMER HAD CALLED PREVIOUSLY FOR SAME ISSUE, THIS IS REPLACEMENT METER THAT HAD BEEN SENT TO CUSTOMER. 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 08/22/2019 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 8006933 ↗
• MalfunctionJul 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED TO REQUEST A REPLACEMENT FOR A BLOOD GLUCOSE METER. CUSTOMER DROPPED THE METER AND IT BROKE. CUSTOMER THREW THE METER AWAY. NO METER AVAILABLE AT THE TIME OF THE CALL. CUSTOMER DIDN'T HAVE ANY COMPLAINT ABOUT THE PERFORMANCE OF THE PRODUCT. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/28/2019 AND OPEN VIAL DATE IS UNDISCLOSED. CUSTOMER WAS NOT FEELING ANY SYMPTOMS OF LOW OR HIGH BLOOD SUGAR AT THE TIME OF THE CALL. CUSTOMER REPORT A PREVIOUS SYMPTOMS AND MEDICAL ATTENTION. ON (B)(6) 2018 CUSTOMER WAS FEELING NAUSEOUS, WEAK AND THIRSTY. CUSTOMERS BLOOD SUGAR READ ABOVE 800MG/DL FASTING AND WENT TO THE HOSPITAL. CUSTOMER WAS FEELING HIGH BLOOD SUGAR SYMPTOMS BUT CANNOT RECALL ANYTHING DONE IN THE HOSPITAL. ALL CUSTOMER REMEMBERS IS THAT SHE WAS GIVEN INSULIN TO BRING THE BLOOD SUGAR DOWN DURING HER STAY IN THE HOSPITAL. PER HOSPITAL'S INSTRUCTION: CUSTOMER WAS ON 10 UNITS AT NIGHT OF LANTUS, CUSTOMER IS TAKING MORE UNITS BUT DOES NOT REMEMBER HOW MUCH MORE AT NIGHT. CUSTOMER ONLY REMEMBERS THAT HER BLOOD SUGAR WAS AT 300MG/DL FASTING WHEN SHE LE

  Patient problems: Hyperglycemia; Hypovolemic Shock; Polydipsia

  MAUDE report 7691692 ↗
• MalfunctionMar 20, 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 39 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115-140MG/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 06/16/2019 AND OPEN VIAL DATE IS ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY(DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7353283 ↗
• MalfunctionMar 12, 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 72, 129 AND 127MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 160MG/DL. CUSTOMER STATED THAT SHE NORMALLY RUNS HIGHER IN THE MORNING THAN THE RESULTS OBTAINED 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 THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 114 MG/DL AND 114 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/16/2019 AND OPEN VIAL DATE AT TIME OF CALL 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 7331138 ↗
• MalfunctionFeb 26, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS PERFORMED NON-FASTING OF 190, 247, 250 AND 110 MG/DL. CUSTOMER STATED HE TESTED RIGHT AFTER THE TRUEMETRIX REPLACEMENT METER WAS RECEIVED ON (B)(6) 2018; TESTS WERE PERFORMED BACK TO BACK. CUSTOMER WAS USING ALCOHOL AND WAS ADVISED OF PROPER TESTING TECHNIQUE. THE CUSTOMER DOES NOT KNOW WHAT HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE SHOULD BE. 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 343 MG/DL AND 266 MG/DL USING TRUEMETRIX METER. CUSTOMER DID NOT STORE SUPPLIES AS HE TESTED RIGHT AFTER METER WAS RECEIVED. 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: (B)(6). TIME NOT PROVIDED BY CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7297242 ↗
• MalfunctionFeb 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER INITIALLY CALLED FOR QUESTIONS AND ASSISTANCE WITH NEW TRUEMETRIX METER. BACK TO BACK CONTROL TESTS PERFORMED DURING CALL ON (B)(6) 2018 WERE OUT OF RANGE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 112 - 120 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING WEAK AND DIZZY; CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE CUSTOMER STATED SHE JUST RECEIVED THE TEST STRIPS ON 01/31/2018. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/16/2019 AND OPEN VIAL DATE IS 01/31/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Dizziness; Weakness

  MAUDE report 7285912 ↗
• MalfunctionFeb 14, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. CUSTOMER WOULD LIKE TO KNOW WHAT E-5 MEAN. WE INFORMED THE CALLER THE ERROR MEANS EITHER TEST STRIP ERROR OR A READING HIGHER THAN 600 MG/DL. CALLER STATES THE CUSTOMER HAS NOT USED INSULIN FOR OVER A MONTH AND BELIEVES HIS SUGAR IS HIGH. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING TIRED. 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 11/30/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue

  MAUDE report 7270131 ↗
• MalfunctionDec 4, 2017High Test Results; High Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR DEAD METER; COMPLAINT WAS ABLE TO BE RESOLVED THROUGH TROUBLESHOOTING. CUSTOMER THEN REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 134 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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) 2017, 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 11/15/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): RESULT 1 :134MG/DL DATE: (B)(6) 2017 TIME:12:00PM FASTING. RESULT 2 :122MG/DL DATE: (B)(6) 2017 TIME:01:10PM FASTING. RESULT 3 : 98MG/DL DATE: (B)(6) 2017 TIME:12:14PM FASTING. RESULT 4 :107MG/DL DATE: (B)(6) 2017 TIME:12:58AM FASTING. RESULT 5 :103MG/DL DATE: (B)(6) 2017 TIME:12:35PM FASTING. CUSTOMER IS CALLING BECAUSE SHE STATES HER METER IS READIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7080227 ↗
• MalfunctionDec 1, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON OF TEST RESULT REPORTED OF 515 MG/DL USING TRUEMETRIX AIR METER AND TEST RESULT REPORTED OF 319 MG/DL USING ANOTHER DEVICE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 250 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 187 MG/DL AND 250 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2017 AND CUSTOMER STATED OPEN VIAL DATE IS "ABOUT 5 DAYS AGO." THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT OBTAINED A READING OF 515MG/DL FASTING ON THE METER. CUSTOMER BECAME WORRIED AND STATED WITHIN 10 MINUTES CUSTOMER TESTED WITH A NEIGHBOR'S METER AND OBTAINED A RESULT OF 319MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6139356 ↗