TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose Meter (REF REA4H01-40)Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 00021292007447), received between Nov 22, 2016 and Sep 13, 2021 — classified as 8 injuries, 166 malfunctions.

The most frequently reported specific device problem is “High Test Results” (115 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 174 reports, 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 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 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 ↗
• MalfunctionJan 3, 2019Low Test Results; Low Test Results

  CALL WAS TRANSFERRED DUE TO CUSTOMER STATING SHE WAS HAVING SYMPTOMS OF FREQUENTLY URINATING, HAD EXCESSIVE THIRST, BLURRY VISION, AND WAS FEELING WEAK/TIRED. CUSTOMER WAS INFORMED THAT THESE ARE SYMPTOMS OF HYPERGLYCEMIA AND TO SEEK MEDICAL ATTENTION. CUSTOMER WAS INSTRUCTED SEVERAL TIMES TO CALL 911 AND STATED THAT SHE WILL NOT GO UNLESS SHE OBTAINS A RESULT. CUSTOMER STATED SHE GOT A RESULT OF 108 MG/DL AND WANTED TO KNOW IF THAT IS CORRECT. CUSTOMER WAS INFORMED DUE TO HER SYMPTOMS, IT SEEMS HER BLOOD SUGAR IS ELEVATED AND TO CALL 911 OR TO REACH OUT TO HER DOCTOR'S OFFICE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. INITIAL CALL HAD BEEN DISCONNECTED, ATTEMPTS TO CONTACT CUSTOMER ON (B)(6) 2018, WERE MADE, BUT WERE UNABLE TO REACH CUSTOMER.

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

  MAUDE report 8212611 ↗
• MalfunctionDec 21, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER DID REPORT SYMPTOM OF NOT FEELING WELL. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 209 AND 207MG/DL NON-FASTING USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/21/2019, AND OPEN VIAL DATE IS LAST MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6) CUSTOMER STATES IN (B)(6), HE DOES NOT REMEMBER THE EXACT DATE, HE WAS NOT FEELING WELL, HE STATES THAT HE WENT TO THE CLINIC TO GET CHECKED OUT. THERE HE STATES THAT THEY RECOMMENDED THAT HE GOES TO THE HOSPITAL. HE STATES THAT THERE WAS NO TREATMENT AT THE CLINIC. CUSTOMER STATES, AT THE HOSPITAL, THERE WERE NO TREATMENT, NO DIAGNOSTIC, AND HE WAS NOT HOSPITALIZED. THEY ONLY CHECKED HIS BLOOD SUGAR. HE STATES THAT

  Patient problems: No Information

  MAUDE report 8189252 ↗
• MalfunctionDec 18, 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 133 AND 146 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) 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 BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/18/2019 AND TEST STRIPS WERE RECENTLY OPENED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ASSISTED CUSTOMER IN SETTING DATE/TIME DURING CALL): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175230 ↗
• MalfunctionDec 18, 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 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF FEELING LIGHTHEADED. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF 100MG/DL. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2019, AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. ASKED CUSTOMER HOW SHE WAS FEELING AND CUSTOMER STATES SHE FEELS LIGHTHEADED. ASKED IF CUSTOMER WAS OK TO CONTINUE WITH THE PRODUCT TROUBLESHOOTING AND CUSTOMER STATES IF SHE NEEDS TO GO TO THE HOSPITAL SHE WILL, BUT AT THIS TIME, SHE STATES SHE IS OK ENOUGH TO CONTINUE WITH THE CALL. CUSTOMER IS CONCERNED OF E-3 ONCE THE STRIP IS INSERTED. CUSTOMER STATES SHE INSERTS THE STRIP INTO THE METER WITH THE BLOOD SAMPLE. WHILE TROUBLESHOOTING, CUSTOMER RAN A BLOOD TEST AND OBTAINED A READING OF 100MG/DL.

  Patient problems: Dizziness

  MAUDE report 8174491 ↗
• MalfunctionOct 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 232 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 105 - 155 MG/DL. CUSTOMER STATED THAT HE IS USING CORRECT TESTING TECHNIQUE. 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 12/31/2018 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 8019317 ↗
• MalfunctionOct 23, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-0 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER DID REPORT SYMPTOMS OF FEELING LIGHT HEADED AND DRY MOUTH. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/29/2017 (EXPIRED) AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Polydipsia

  MAUDE report 7996618 ↗
• MalfunctionOct 11, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED THAT IT STARTED A WEEK AGO. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM REPORTED BACK TO BACK BLOOD TESTS OF 330 AND 150 MG/DL FASTING. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 130 MG/DL. THE CUSTOMER IS ONLY CONCERNED WITH THE ERRATIC BLOOD RESULTS, NOT 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 THE CLOSET. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/28/2018 (TEST STRIPS ARE EXPIRED AT TIME OF CALL) AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7957308 ↗
• MalfunctionOct 4, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 93 AND 73 MG/DL. CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 160 MG/DL. CUSTOMER DID STATE THAT THE TRUEMETRIX AIR METER HAD BEEN DROPPED AND THAT SINCE THAT HAPPENED IT HAD BEEN READING LOW. 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 NON-FASTING AND PRODUCED TEST RESULT OF 201 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/21/2019 AND CUSTOMER COULD NOT RECALL THE OPEN VIAL DATE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER COULD NOT SEE DATE/TIME): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7934338 ↗
• MalfunctionOct 3, 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 185 MG/DL. 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. CUSTOMER WAS NOT AVAILABLE DURING THE CALL ON (B)(6) 2018 TO PERFORM A BACK TO BACK BLOOD TEST. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/27/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :342MG/DL DATE: (B)(6) 2018 TIME:10:02AM NON-FASTING; RESULT 2 :160MG/DL DATE: (B)(6) 2018 TIME:3:11AM FASTING; RESULT 3 :153MG/DL DATE: (B)(6) 2018 TIME:2:34PM NON-FASTING; RESULT 4 :185MG/DL DATE: (B)(6) 2018 TIME:12:30AM FASTING; RESULT 5 :115MG/DL DATE: (B)(6) 2018 TIME:2:08AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7930194 ↗
• MalfunctionOct 1, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 530MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-100MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE OFFICE. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 107 AND 99MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS A MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER STATES SHE OBTAINED 530MG/DL FASTING UPON RISING ABOUT 2 AM IN THE MORNING ABOUT 2 WEEKS AGO. CUSTOMER STATES SHE IS NOW TESTING WITH A NEW VIAL. CUSTOMER STATES SHE GOT A READING OF 53MG/DL FASTING THIS MORNING WITH SYMPTOMS OF LOW GLUCOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7924040 ↗
• MalfunctionSep 28, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 347, 440, 338, 290 AND 427 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 165 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 05/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920196 ↗
• MalfunctionSep 24, 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 177 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 92 - 129 MG/DL. 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 162 AND 155 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 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903042 ↗
• MalfunctionSep 7, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 216, 240, 199, 231 AND 215 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-150MG/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 11/30/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER COULD NOT READ DATE/TIME): (B)(6). CUSTOMERS TIME AND DATE CANNOT BE CONFIRMED BECAUSE SHE CANNOT READ THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855064 ↗