TRUE METRIX PRORecalls & reported problems across all models

We found 5 models of TRUE METRIX PRO by Trividia Health, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2016 and Jun 27, 2024 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

TRUE METRIX PRO recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 6, 2026Open, Classified

   The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

   Z-1546-2026 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported TRUE METRIX PRO problems

TRUE METRIX PRO models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUE METRIX PRO Professional Monitoring Blood Glucose Meter TRUE METRIX PRO

  System, Test, Blood Glucose, Over The Counter
  1 recall0 reports
• TRUE METRIX PRO TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER

  System, Test, Blood Glucose, Over The Counter
  1 recall0 reports
• TRUE METRIX PRO TRUE METRIX PRO BLOOD GLUCOSE TEST STRIPS - 50 Test Strips

  Glucose Dehydrogenase, Glucose
  20 reports
• TRUE METRIX PRO TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER FOR MULTIPLE PATIENT

  System, Test, Blood Glucose, Over The Counter
  2 reports
• TRUE METRIX PRO TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER

  System, Test, Blood Glucose, Over The Counter
  1 report

Recent TRUE METRIX PRO adverse event reports

The 15 most recent reports across all models, 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 30, 2018High 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 FROM RESULTS OBTAINED OF 252, 364, 219, 222 AND 220 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 160 MG/DL THE CUSTOMER IS USING TRUEMETRIX PRO METER; CUSTOMER WAS INFORMED THAT METER IS FOR MULTI PATIENT USE AND WILL REPLACE WITH 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/20/2020 AND OPEN VIAL DATE IS 10/10/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8021774 ↗
• 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 ↗
• MalfunctionJun 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT OF E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE E-3 ERROR OCCURRED AFTER THE BLOOD SAMPLE WAS APPLIED. DURING THE CALL ON (B)(6) 2018, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS NOT PERFORMED AS CUSTOMER WAS NOT AT HOME AT THE TIME. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/19/2018 AND OPEN VIAL DATE IS UNDISCLOSED. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7616074 ↗

Other Trividia Health, Inc. products

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