TRUE METRIX AIR TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE METER (REF REA4011-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00087701427398), received between Apr 11, 2017 and Dec 13, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 200MG/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 11/20/2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 286 AND 295MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/16/2019 AND OPEN VIAL DATE IS 10/20/18. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1:305MG/DL, DATE: (B)(6) 2018, TIME:12:11PM, FASTING; RESULT 2:354MG/DL, DATE: (B)(6) 2018, TIME:12:03PM, FASTING; RESULT 3:250MG/DL, DATE: (B)(6) 2018, TIME:11:54AM, FASTING; RESULT 4:255MG/DL, DATE: (B)(6) 2018, TIME:7:54AM, FASTING; RESULT 5:254MG/DL, DATE: (B)(6) 2018, TIME:10:36AM, FASTING; RESULT 6:HI, DATE: (B)(6) 2018, TIME:5:01PM, NON-FASTING. AT THE TIME OF THE CALL CUSTOMER STATES SHE WAS HOSPITALIZED IN (B)(6) OF 2017. CUSTOMER STATES THAT WENT TO THE HOSPITAL DUE TO NECK PAIN, FAST PULSE, AND FEET CRAMPED. CUSTOMER WA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8162585 ↗
• MalfunctionNov 6, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 165 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 88 TO 130 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). (B)(6). CUSTOMER IS CONCERNED WITH HIGH RESULTS THAT WERE PERFORMED FASTING. COMPLAINTS THAT THE METER IS READING HIGHER THAN HIS A1C.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7003040 ↗
• MalfunctionSep 5, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULT OF 60MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 108MG/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 BY CUSTOMER ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/14/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY): (B)(6). CUSTOMER CALLED JUST RECEIVED THIS METER AND STRIPS FROM HIS DR'S PHARMACY AND SHE NOTICED HOW MUCH LOWER THE BLOOD RESULTS WERE ON THIS METER COMPARED TO THE ACCUCHECK THAT SHE HAS BEEN USING WITH MUCH SUCCESS. SHE SAID SHE HAS GONE TO THE DR'S TO CHECK OUT HER ACCUCHECK SO SHE KNOWS IT IS RUNNING SIMILAR TO THE DR'S BLOOD RESULTS AND THIS METER IS COMING IN WAY TOO LOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6843629 ↗
• MalfunctionJul 13, 2017High 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 265 AND 362 MG/DL. CUSTOMER STATES THAT THE READINGS ARE HIGHER BUT HER MAIN CONCERN IS DUE TO ERRATIC READINGS BACK TO BACK AS SHE DOES NOT KNOW HOW MUCH INSULIN TO ADMINISTER WITH THE READINGS THE METER IS GIVING HER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 200 MG/DL. AT THE TIME OF THE CALL ON (B)(6) 2017, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER STATED THAT ON (B)(6) 2017 THE METER READ 125 MG/DL SHE HAD FELT NAUSEOUS, WAS SWEATY, WAS PALE, AND WAS IN AND OUT OF CONSCIOUSNESS. CUSTOMER STATED SHE DRANK ORANGE JUICE AT THE TIME. CUSTOMER STATED SHE WORKS AT A HOSPITAL AND HER CO-WORKERS TOOK HER TO THE EMERGENCY ROOM. CUSTOMER STATED THE LAB RESULT AT THE HOSPITAL WAS 40 MG/DL AFTER THE ORANGE JUICE. CUSTOMER STATED SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND WAS GIVEN D50 AND TWO BAGS OF FLUID VIA IV. CUSTOMER STATED SHE WAS DISCHARGED ON THE SAME DAY (B)(6) 2017 AND THAT SHE WAS IN THE HOSPITAL FOR ABOUT SIX HOURS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS

  Patient problems: Hypoglycemia; Nausea; Sweating

  MAUDE report 6712332 ↗
• MalfunctionJun 19, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF HAVING A HEADACHE. 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/19/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. THE CUSTOMER STATED THAT METER IS DISPLAYING E-5 WHEN THE BLOOD IS APPLIED TO THE TEST STRIP. THE CUSTOMER IS USING PROPER TESTING TECHNIQUE. THE CUSTOMER STATED THAT SHE HAS A HEADACHE THAT MAY BE RELATED TO DIABETES.

  Patient problems: Headache

  MAUDE report 6652075 ↗
• MalfunctionMay 25, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED THAT HE TOOK HIS METER TO THE DOCTOR (CUSTOMER HAD A PREVIOUS APPOINTMENT) AND THEY RAN A BLOOD TEST AND COMPARED IT WITH THEIR METER AND THE TRUE METRIX METER WAS GIVING HIGHER RESULTS (COMPARISON RESULTS NOT PROVIDED). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 151 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 86 - 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) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND CUSTOMER STATED STRIPS HAVE BEEN OPEN FOR ABOUT THREE - FOUR MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET):128MG/DL (B)(6) 2016 06:35 PM FASTING: YES; 151MG/DL (B)(6) 2016 06:09 PM FASTING: YES; 136MG/DL (B)(6) 2016 06:04 PM FASTING: YES; 128MG/DL (B)(6) 2016 06:21 PM FASTING: YES;129MG/DL (B)(6) 2016 01:59 PM FASTING: YES. MEMORY CONCERNS: CUSTOMER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6591393 ↗
• MalfunctionApr 11, 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 43MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120MG/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 STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 152 AND 136MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2018 AND OPEN VIAL DATE IS APPROXIMATELY TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER STATES THAT HE RUN TWO TEST GOT RESULTS IN 40- 50MG/DL FASTING. CUSTOMER IS CONCERN WITH THE METER GIVING LOW BLOOD RESULTS. CUSTOMER ATE SOME FRUITS AND IT WENT UP THE 177MG/DL .CUSTOMER STATES THAT IF HE GLUCOSE WAS LOW IN THE 40S MG/DL HE WOULD BE HAVING SYMPTOMS BUT HE WAS FEELING FINE. CUSTOMER IS TAKING INSULIN AND TEST 4 TIMES A DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6482680 ↗