TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER (REF REA4081-40)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00021292007164), received between Jan 12, 2017 and Aug 2, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE HIGH RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 135MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. 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, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 201 AND 205MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY), (B)(6). CUSTOMER STATES THAT SHE NEVER HAD SUCH HIGH RESULTS BEFORE. CUSTOMER WAS USING ANOTHER VIAL OF TEST STRIPS WHICH IS NOW FINISHED. CUSTOMER DID NOT PROVIDE LOT NUMBER FROM THE TEST STRIPS THAT WAS GIVING HER PROBLEM. PERFORMED BACK TO BACK TESTING WITH THE NEW VIAL OF TEST STRIPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7744643 ↗
• MalfunctionJan 26, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 TO 150MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 131 AND 139MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/01/2017 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: THE CUSTOMER IS CONCERNED WITH RESULTS OF 115,112, 79 AND 113MG/DL IN THE METER'S MEMORY. THE CUSTOMER IS CALLING IN REGARDS TO GETTING LOW RESULTS ON THE METER WHEN SHE PERFORMS HER BLOOD TEST. THE CUSTOMER IS NOT HAVING ANY SYMPTOMS OF LOW BLOOD SUGAR NOW. SHE IS FEELING WELL. SHE TAKES HER BLOOD TEST FASTING IN THE MORNINGS. SHE TAKES LANTUS AND METFORMIN TO MANAGE HER DIABETES. THE CUSTOMER IS CON

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6279214 ↗
• MalfunctionJan 26, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. (B)(6) IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 60 AND 79 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 152 MG/DL AND 154 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/28/2017 AND OPEN VIAL DATE IS MONTH OF (B)(6) 2016. THE CUSTOMER HAD NOT HAD ANY CHANGES IN HIS DIET OR EXERCISE REGIMEN AND TAKES LANTUS TO MANAGE HIS DIABETES. 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 METER'S MEMORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6279154 ↗
• MalfunctionJan 12, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. (B)(6), IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 TO 130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/25/2017 AND OPEN VIAL DATE IS APPROXIMATELY TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE / TIME NOT SET): (B)(4). CUSTOMER STATES THAT FOR 3 DAYS HE HAS BEEN SICK WITH A SINUS INFECTION AND WAS GIVEN STEROIDS AND ANTIBIOTIC AND HAVE NOTICE THE INCREASE IN HIS RESULTS SINCE. DAUGHTER BELIEVES IT IS BECAUSE OF THE STEROIDS AND ANTIBIOTICS THAT HAVE INCREASE HIS BLOOD SUGAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6245269 ↗