TRUE METRIX AIR TRUE METRIX AIR self monitoring blood glucose meter (REF REA4089-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00052569139042), received between Jan 31, 2017 and Dec 27, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2018Image Display Error/Artifact; Image Display Error/Artifact

  CONSUMER REPORTED COMPLAINT FOR BROKEN DISPLAY. AT THE TIME OF THE CALL, THE CUSTOMER STATED SHE WAS FEELING NERVOUS AND BELIEVED THAT HER BLOOD GLUCOSE WAS DROPPING. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER STATED THAT SHE SAW THREE DASHES DISPLAYED ACROSS THE SCREEN. CUSTOMER WAS INFORMED THAT THE THREE DASHES MEANS THE DISPLAY OF THE METER IS BROKEN.

  Patient problems: No Code Available

  MAUDE report 8199424 ↗
• MalfunctionDec 7, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR METER NOT READING BLOOD RESULTS ACCOMPANIED BY SYMPTOMS. FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING SLEEPY AND HAVING EXCESSIVE THIRST. 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 10/13/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER FEELS SLEEPY AND HAS EXCESSIVE THIRST. PUTS THE STRIP INTO THE METER AND ONCE THE BLOOD IS ABSORBED IT DOES NOT GO INTO TEST MODE.

  Patient problems: Lethargy; Polydipsia

  MAUDE report 8142937 ↗
• MalfunctionOct 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 291, 140, 133 AND 151 MG/DL. CUSTOMER ALSO STATED HE COMPARED TRUEMETRIX AIR METER TO TWO OTHER METERS AT THE DOCTOR'S OFFICE DURING A ROUTINE SCHEDULED APPOINTMENT. CUSTOMER STATED TRUEMETRIX AIR READ 38 POINTS HIGHER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:114MG/DL DATE: (B)(6) 2018 TIME:9:31PM FASTING, RESULT 2:291MG/DL DATE: (B)(6) 2018 TIME:9:52AM FASTING, RESULT 3:140MG/DL DATE: (B)(6) 2018 TIME:8:11AM FASTING, RESULT 4:133MG/DL DATE: (B)(6) 2018 TIME:6:49AM FAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7977734 ↗
• MalfunctionAug 8, 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 CODE. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE E-3 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER WAS USING IMPROPER TESTING TECHNIQUE. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 334 MG/DL NON-FASTING. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. DAUGHTER STATED THAT CUSTOMER WAS HOSPITALIZED FROM (B)(6) 2018. CUSTOMER HAD GOTTEN INTO AN ARGUMENT WITH A FAMILY MEMBER AND SHORTLY AFTER CUSTOMER HAD BLURRY VISION AND HAD FAINTED. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL WAS 441 MG/DL FASTING. THE DIAGNOSIS WAS HYPERGLYCEMIA AND HYPERTENSION AND CUSTOMER HAD INSULIN ADMINISTERED EVERY HOUR. NEW MEDICATION, INSULIN, HAD BEEN SUGGESTED BY HEALTHCARE PROFESSIONAL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/15/2019 AND OPEN VIAL DATE IS 07/12/2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Blurred Vision; Hyperglycemia; Loss of consciousness

  MAUDE report 7762420 ↗
• MalfunctionJul 24, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 172MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN (NEWLY DIAGNOSED). THE CUSTOMER DID NOT REPORT SYMPTOMS. 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 11/30/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). TIME:10:04PM 159MG/DL DATE: (B)(6); TIME:8:53PM 160MG/DL DATE: (B)(6); TIME:8:49M 131MG/DL DATE: (B)(6); TIME:8:45PM 170MG/DL DATE: (B)(6); TIME:8:39PM 198MG/DL DATE: (B)(6). PHARMACY CALLED ON BEHALF OF CUSTOMER AND STATED THAT CUSTOMER WENT TO THE PHARMACY DUE TO OUR PRODUCT. CUSTOMER TESTED AT HOME AND GOT A READING OF 172MG/DL (DID NOT SPECIFY IF ITS FASTING OR NONE). CUSTOMER WENT TO THE HOSPITAL AND READINGS WERE MUCH LOWER. PHARMACIST DOES NOT KNOW HOW LONG AFTER DID HE GO TO THE HOSPITAL. CUSTOMER ADVISED PHARMACIST THAT NO TREATMENT WAS PROVIDED, THE HOSPITAL PROVIDED HIM WITH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7713533 ↗
• MalfunctionJun 26, 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 221 AND 205 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75 - 120 MG/DL. CUSTOMER WAS UNSURE IF OTHER RESULTS WERE FASTING OR NON-FASTING. 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 WAS NOT FASTING AT TIME OF CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS A FEW WEEKS. 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 7639342 ↗
• MalfunctionApr 5, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-2 ACCOMPANIED BY SYMPTOMS.. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF FEELING WEAK. 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, BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 86 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/18/2019 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Weakness

  MAUDE report 7400357 ↗
• MalfunctionApr 2, 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 90 TO 116 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 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 104 AND 104 MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 3/31/19 AND OPEN VIAL DATE IS A MONTH AND A HALF AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): (B)(6). CUSTOMER IS CONCERNED WITH THE HIGH RESULTS THAT HE IS GETTING FROM HIS METER. CUSTOMER STATED THAT HE WENT TO THE DOCTOR YESTERDAY AND WAS ADVISED THAT HIS A1C WAS 6.5 AND THE DOCTOR TESTED HIS BLOOD GLUCOSE ON HIS METER (CUSTOMER DID NOT KNOW WHAT THE RESULT FROM HIS DOCTOR'S METER WAS) AND TESTED HIMSELF ON HIS METER AND THE RESULTS WERE AROUND 25 POINTS OFF. CUSTOMER DID NOT SET UP THE TIME IN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7390826 ↗
• MalfunctionJan 3, 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 193, 186, 209, 282 AND 311 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. DUE TO IMPROPER STORAGE OF TEST STRIPS, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER DURING THE CALL ON (B)(6) 2017. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM; CUSTOMER WAS INSTRUCTED ON PROPER STORAGE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): (B)(6). CUSTOMER IS CONCERNED WITH ALL FASTING RESULTS OBTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7162262 ↗
• MalfunctionApr 13, 2017High 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 169 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/27/2017 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED AND STATED THAT THE METER IS GIVING HIS HIGH RESULTS. CUSTOMER STATES HE IS A NEW DIABETIC AND HAS HIS A1C DONE AND OBTAINED 6.6.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6489402 ↗
• MalfunctionMar 22, 2017Low 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 80, 69 AND 58 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75 - 125 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 STATED HE HAS BEEN GETTING HIGH RESULTS AS WELL BUT IS MORE CONCERNED WITH THE LOW RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER HAD JUST EATEN. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/27/2018 AND OPEN VIAL DATE IS MONTH OF (B)(6) 2017. CUSTOMER STATED HE TAKES HIS BLOOD TEST FASTING IN THE MORNINGS AND THE EVENINGS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:THE CUSTOMER IS CONCERNED WITH THE 5 RESULTS PROVIDED IN THE METERS MEMORY HE TAKES HIS BLOOD TEST FASTING IN THE MORNINGS AND THE EVENINGS. HE HAS BEEN GETTING HIGH RESULTS AS WELL BUT IS MORE CONCERNED WITH THE LOWS. HE SAID WHEN HE GOT THE LOW RESULTS HE WAS NOT HAVING AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6425077 ↗
• MalfunctionJan 31, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 ACCOMPANIED WITH SYMPTOMS. HUSBAND, (B)(6), IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF E-0 AND SYMPTOMS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 300 TO 450MG/DL. THE CUSTOMER REPORTED SYMPTOMS OF BEING UNCONSCIOUS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/28/2018 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER CALLED IN STATES THE METER IS READING E-2. WHILE TROUBLESHOOTING CUSTOMER STATES THE METER READ E-0. HUSBAND STATES HIS WIFE IS ON DIALYSIS AND IS ANEMIC. CUSTOMER STATES THAT HE HAS TO TEST TEN TIMES UNTIL HIS WIFE GETS A READING. CUSTOMER STATES ON (B)(6) 2017 METER READ 137MG/DL FASTING AFTER TEN ATTEMPTS. HUSBAND ADMINISTERED 22 UNITS OF LANTUS AND 4 UNITS OF HUMALOG. STATES HIS WIFE USUALLY RECEIVES THAT DOSE AND SHE ALSO TAKES (B)(4) IN THE MORNING. HUSBAND STATES HE RECEIVED A CALL FROM HIS DAUGHTER AT 10AM STATING THAT HIS WIFE WAS NOT WAKING UP AND HE INSTRUCTED H

  Patient problems: Hypoglycemia; Syncope

  MAUDE report 6290575 ↗