TRUE METRIX AIRRecalls & reported problems across all models
Trividia Health, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one TRUE METRIX AIR model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 693
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 1
We found 16 models of TRUE METRIX AIR by Trividia Health, Inc. in the FDA's device registry (GUDID). Together they are named in 693 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Sep 13, 2021 — classified as 8 injuries, 685 malfunctions.
The most frequently reported specific device problem is “High Test Results” (439 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 AIR 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.
- 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-1547-2026 · Root cause: Software design · names 4 of these models · Recall details · FDA record ↗
Most reported TRUE METRIX AIR problems
Device problems
- High Test Results439
- Low Test Results101
- Device Displays Incorrect Message72
- Incorrect Or Inadequate Test Results38
- Adverse Event Without Identified Device or Use Problem26
- Unable to Obtain Readings20
- Incorrect, Inadequate or Imprecise Result or Readings12
- Battery Problem8
Patient problems
- No Known Impact Or Consequence To Patient468
- Fatigue38
- Dizziness37
- Polydipsia35
- Headache27
- Hypoglycemia26
- Urinary Frequency / Polyuria26
- Weakness25
TRUE METRIX AIR models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose MeterSystem, Test, Blood Glucose, Over The Counter174 reports
- TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE SYSTEMSystem, Test, Blood Glucose, Over The Counter169 reports
- TRUE METRIX AIR TRUE METRIX AIR self monitoring blood glucose meterSystem, Test, Blood Glucose, Over The Counter1 recall65 reports
- TRUE METRIX AIR TRUE METRIX AIR self monitoring blood glucose meterSystem, Test, Blood Glucose, Over The Counter57 reports
- TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METERGlucose Dehydrogenase, Glucose56 reports
- TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose MeterSystem, Test, Blood Glucose, Over The Counter1 recall4 reports
- TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose MeterSystem, Test, Blood Glucose, Over The Counter1 recall0 reports
- TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose MeterSystem, Test, Blood Glucose, Over The Counter1 recall0 reports
- TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METERSystem, Test, Blood Glucose, Over The Counter47 reports
- TRUE METRIX AIR Publix true metrix air SELF-MONITORING BLOOD GLUCOSE METERSystem, Test, Blood Glucose, Over The Counter34 reports
- TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METERSystem, Test, Blood Glucose, Over The Counter25 reports
- TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose MeterSystem, Test, Blood Glucose, Over The Counter24 reports
- TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose MeterSystem, Test, Blood Glucose, Over The Counter15 reports
- TRUE METRIX AIR TRUE METRIX AIR self monitoring blood glucose meterSystem, Test, Blood Glucose, Over The Counter12 reports
- TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METERSystem, Test, Blood Glucose, Over The Counter7 reports
- TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METERSystem, Test, Blood Glucose, Over The Counter4 reports
Recent TRUE METRIX AIR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 13, 2021Failure to Power Up; Failure to Power Up
CONSUMER REPORTED COMPLAINT FOR DEAD METER. CUSTOMER STATED THE BATTERY HAD BEEN CHANGED (B)(6) 2021. THE CUSTOMER IS USING THE CORRECT BATTERY IN THE CORRECT ORIENTATION FOR THE METER. DURING THE CALL, THE TRUE METRIX AIR METER DID NOT POWER ON USING THE POWER BUTTON OR WHEN A TEST STRIP WAS INSERTED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/25/2022 AND OPEN VIAL DATE IS LESS THAN 4 MONTHS (EXACT DATE WAS NOT DISCLOSED). CUSTOMER STATED THAT SHE HAD TESTED AND OBTAINED A RESULT OF 40MG/DL FASTING AND WHEN SHE ATTEMPTED TO TEST AGAIN LATER THE TRUE METRIX AIR METER DID NOT POWER ON. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING DIZZY AND STATED SHE WAS GOING TO CONTACT HER DOCTOR. CUSTOMER DOCTOR CALLED WHILE ATTEMPTED TO TROUBLE SHOOT. CUSTOMER DID NOT STATE WHY THE DOCTOR WAS CALLING OR IF IT WAS RELATED TO SYMPTOM. CUSTOMER DISCONNECTED
Patient problems: Dizziness
MAUDE report 12464930 ↗InjuryJul 1, 2021Battery Problem; Battery Problem
CONSUMER REPORTED COMPLAINT FOR BATTERY ISSUE, STATING THE TRUE METRIX AIR METER WOULD NOT TURN ON. CUSTOMER STATED THE BATTERY HAD NEVER BEEN CHANGED. DURING THE CALL, THE TRUE METRIX AIR METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 188MG/DL USING TRUE METRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING AREA. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/27/2022 AND OPEN VIAL DATE WAS NOT DISCLOSED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING LIGHTHEADED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME.
Patient problems: Dizziness
MAUDE report 12101378 ↗InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER CALLED FOR TRAINING ON PERFORMING A BLOOD TEST. BOTH VIALS OF TEST STRIPS THE CUSTOMER HAD AVAILABLE WERE EXPIRED: MT2142, MANUFACTURER'S EXPIRATION DATE OF 04/24/2018 AND MT1782, MANUFACTURER'S EXPIRATION DATE OF 10/28/2017. CUSTOMER STATED SHE HAD THE METER FOR SEVERAL YEARS AND THAT WHEN SHE FIRST GOT IT SHE DIDN'T LIKE IT, SO SHE HAD STORED IT AND DIDN'T USE IT. CUSTOMER WAS GOING TO PURCHASE NEW TEST STRIPS. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. DURING THE CALL, THE CUSTOMER HAD STATED THAT EARLIER THAT MORNING SHE HAD BEEN "OUT OF IT", SCREAMING AND CARRYING ON. CUSTOMER'S SON'S HAD CALLED 911. WHEN THE PARAMEDICS ARRIVED THEY HAD PERFORMED A BLOOD TEST USING THEIR DEVICE AND HAD OBTAINED A RESULT OF 15 MG/DL (NOT DISCLOSED IF FASTING OR NON-FASTING). CUSTOMER HAD BEEN TREATED WITH AN INJECTION OF DEXTROSE AND TOLD TO EAT. PRIOR TO LEAVING, THE PARAMEDICS HAD TESTED CUSTOMER'S BLOOD GLUCOSE AND THE RESULT HAD BEEN 156 MG/DL NON-FASTING. CUSTOMER HAD DECLINED TO GO TO THE HOSPITAL.
Patient problems: Hypoglycemia
MAUDE report 11277042 ↗InjurySep 10, 2020Failure to Power Up; Failure to Power Up
CONSUMER REPORTED COMPLAINT FOR DEAD METER. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF DISORIENTATION AND STUTTERING. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER HAD CHANGED THE BATTERY ON DAY OF CALL ((B)(6) 2020). DURING THE CALL THE TRUEMETRIX AIR METER DID NOT TURN ON BY USING THE POWER BUTTON OR WHEN A TEST STRIP WAS INSERTED.
Patient problems: Confusion/ Disorientation
MAUDE report 10518703 ↗InjuryJul 29, 2020Low Test Results; Low Test Results
CONSUMER REPORTED COMPLAINT FOR LOW AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 74 MG/DL AND BACK TO BACK BLOOD TESTS OF 144, 135, 120 AND 134 MG/DL. THE CUSTOMER DID NOT KNOW WHAT HIS EXPECTED GLUCOSE RANGE SHOULD BE. THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION WAS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AT TIME OF INITIAL CALL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 68 MG/DL AND 71 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/17/2021 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10337667 ↗InjuryJul 24, 2020High Test Results; High Test Results
CONSUMER REPORTED COMPLAINT FOR METER DOES NOT TURN ON WITH STRIP INSERTED ACCOMPANIED BY SYMPTOMS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF SWEATING AND HEADACHE. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2021 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.
Patient problems: Headache; Hyperglycemia; Lethargy; Sweating
MAUDE report 10323359 ↗InjuryApr 21, 2020Battery Problem; Battery Problem
CONSUMER REPORTED COMPLAINT FOR DEAD METER, STATING THAT THE TRUEMETRIX AIR METER WOULD NOT TURN ON. THE BATTERY HAD BEEN CHANGED A FEW DAYS PRIOR TO THE CALL. CUSTOMER WAS FEELING NAUSEATED AT THE TIME OF THE CALL BUT DENIED THE NEED FOR MEDICAL ATTENTION. DURING THE CALL, THE TRUEMETRIX AIR METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED. THE "LOW BATTERY" SYMBOL DID NOT DISPLAY. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 167 MG/DL USING TRUEMETRIX AIR METER. CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED.
Patient problems: Nausea
MAUDE report 9981360 ↗InjuryMar 10, 2020Device Displays Incorrect Message; Device Displays Incorrect Message
CONSUMER REPORTED COMPLAINT FOR E-0 ACCOMPANIED BY SYMPTOM. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF SLURRED SPEECH AND FEELING WEAK. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BASEMENT AREA. DURING THE CALL A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/26/2020 AND OPEN VIAL DATE IS 2/11/2020. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.
Patient problems: Weakness
MAUDE report 9811073 ↗MalfunctionNov 11, 2019High Test Results; High Test Results
CONSUMER INITIALLY CALLED NEEDING ASSISTANCE WITH PERFORMING A CONTROL SOLUTION TEST. CUSTOMER THEN REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 217, 243, 395 MG/DL FASTING AND 249, 194 AND 343 MG/DL NON-FASTING. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 125 MG/DL; AN EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULTS RANGE WAS 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, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 235 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/19/2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9306441 ↗MalfunctionJan 24, 2019High Test Results; Low Test Results; High Test Results; Low Test Results
CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH HIGH TESTS RESULTS FROM RESULTS OBTAINED OF294 AND 236MG/DL AND LOW RESULTS OBTAINED OF 89MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 180MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 245 AND 281MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/24/2020, AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8274110 ↗MalfunctionJan 17, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
CONSUMER REPORTED COMPLAINT FOR DEFECTIVE LCD. CUSTOMER STATED SHE WAS SEEING PARTIAL CHARACTERS AND ONLY 25 ON THE SCREEN. NO MEDICATION WAS ADMINISTERED BASED ON THE RESULTS DISPLAYED. THE METER WAS NOT DROPPED OR MISHANDLED. THE LCD SCREEN DOES NOT HAVE ANY PHYSICAL DAMAGE, CUSTOMER JUST STATED IT APPEARS BURNT. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID REPORT A PAST ADVERSE EVENT STATING THAT ON (B)(6) 2018, SHE HAD BEEN RUSHED TO THE HOSPITAL VIA AMBULANCE DUE TO DIZZINESS AND VOMITING. CUSTOMER STATED SHE WAS UNABLE TO OBTAIN A READING DUE TO THE DISPLAY ON THE SCREEN SHOWING PARTIAL CHARACTERS AND SHE FEARED HER GLUCOSE WAS ELEVATED. CUSTOMER'S BLOOD GLUCOSE TEST RESULT AT THE HOSPITAL WAS OVER 200 MG/DL NON-FASTING AND CUSTOMER STATED THAT WAS VERY HIGH FOR HER. THE DIAGNOSIS WAS HYPERGLYCEMIA AND CUSTOMER WAS ADMITTED FOR 24 HOURS AND TREATED WITH IV FLUIDS WITH MEDICATION IN ORDER TO BRING HER BLOOD GLUCOSE DOWN. CUSTOMER WAS RELEASED (B)(6) 2018, WHEN HER BLOOD GLUCOSE RESULT WAS 94MG/DL FASTING. NO CHANGES WERE MADE TO CUSTOMER'S MEDICATION REGIMEN, BUT CUSTOMER WAS ADVISED TO SEEK OUT ANOTHER METER.
Patient problems: Dizziness; Hyperglycemia; Vomiting
MAUDE report 8258219 ↗MalfunctionJan 15, 2019High 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 TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 125 MG/DL. AT THE TIME OF THE CALL,THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2018, SHE WAS SHAKING AND HAVING INCREASED URINATION SO SHE WENT TO THE DOCTOR. CUSTOMER STATED THAT SHE WAS AT HER DOCTOR'S OFFICE AND WAS ADVISED TO GO STRAIGHT TO THE HOSPITAL. CUSTOMER WAS ADMITTED ON (B)(6) 2018. CUSTOMER STATED THAT WHEN SHE FIRST GOT TO THE HOSPITAL, THEY WERE UNABLE TO TEST HER BLOOD SUGAR, BUT WHEN THEY EVENTUALLY GOT A RESULT IT WAS 900 MG/DL FASTING. CUSTOMER STATED THAT SHE WAS GIVEN AN INSULIN DRIP TO LOWER HER BLOOD GLUCOSE. CUSTOMER WAS DISCHARGED ON (B)(6) 2018, AND WAS ADVISED BY THE DISCHARGING PHYSICIAN TO FOLLOW-UP WITH HER PRIMARY CARE DOCTOR. CUSTOMER DID DISCLOSE THAT SHE HAD STOPPED TAKING HER METFORMIN MEDICATION AT LEAST 4-5 DAYS PRIOR TO GOING TO HER DOCTOR. 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 HI AND HI USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORD
Patient problems: Shaking/Tremors; Urinary Frequency / Polyuria
MAUDE report 8249711 ↗MalfunctionJan 11, 2019Low Test Results; Low Test Results
CONSUMER INITIALLY REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE CUSTOMER'S TEST STRIPS WERE EXPIRED: LOT # MT2239, MANUFACTURER'S EXPIRATION DATE OF 05/22/2018. CUSTOMER DID NOT HAVE ANOTHER VIAL AND WAS GOING TO PURCHASE. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING SLIGHTLY TIRED AND STATED IT WAS DUE TO HER BLOOD SUGAR. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL ON (B)(6) 2018. CUSTOMER REPORTED A PAST ADVERSE EVENT STATING SHE HAD TAKEN A MEDICATION THAT SEEMED TO HAVE LOWERED HER BLOOD GLUCOSE AND THAT SHE DOES NOT REMEMBER WHAT HAPPENED AND WAS TAKEN TO THE HOSPITAL. SPOKE WITH CUSTOMER'S GRANDDAUGHTER TO OBTAIN FURTHER DETAILS. ON (B)(6) 2018, CUSTOMER WAS UNCONSCIOUS AND UNRESPONSIVE, HAD BEEN SNORING VERY LOUDLY AND DROOLING. 911 HAD BEEN CALLED. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WITH THE PARAMEDIC'S METER WAS 46 MG/DL FASTING. THE CUSTOMER WAS TAKEN TO THE HOSPITAL; THE DIAGNOSIS WAS HYPOGLYCEMIA. THE CUSTOMER AND GRANDDAUGHTER DID NOT KNOW WHAT TREATMENT WAS RECEIVED. THE CUSTOMER WAS DISCHARGED AT 5:00 AM ON (B)(6) 2018. NO NEW MEDICATIONS OR HEALTHCARE PROGRAM HAD
Patient problems: Fatigue
MAUDE report 8241957 ↗MalfunctionJan 11, 2019High Test Results; High Test Results
CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 436 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 - 180 MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT LIGHTHEADED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. NURSE STATED THAT ABOUT ONE MONTH AGO (DOES NOT REMEMBER THE EXACT DATE), THE CUSTOMER HAD GONE TO THE ER. THE CUSTOMER HAD FELT LIGHTHEADED BUT COULD NOT VERBALIZE THAT. NURSE DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE ER. THE DIAGNOSIS WAS HYPERGLYCEMIA; CUSTOMER DID NOT RECEIVE ANY TREATMENT. UPON DISCHARGE, IT WAS RECOMMENDED THE CUSTOMER DRINK MORE WATER AND BE GIVEN INSULIN WHEN HE WENT HOME AND THE CUSTOMER'S DIET WAS CHANGED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 349 MG/DL AND 391 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN A MEDICATION CART. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/27/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE M
Patient problems: Hyperglycemia
MAUDE report 8240447 ↗MalfunctionJan 9, 2019High Test Results; High Test Results
CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 255, 245, 191, 232 AND 187 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 148 MG/DL. CUSTOMER STATED THAT THERE WERE CHANGES IN HER MEDICATION OVER THE LAST FEW MONTHS AND SINCE THE CHANGES OCCURRED, HER READINGS HAVE BEEN 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 BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN A PAJAMA DRAWER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2020, AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8231743 ↗
Other Trividia Health, Inc. products
All Trividia Health, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page