TRUE METRIX AIR TRUE METRIX AIR Self Monitoring Blood Glucose Meter (REF REA4094-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00681131240154), received between Apr 18, 2018 and Nov 26, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Feb 6, 2026Class IOpen, 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 · Recall details · FDA record ↗

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.

• MalfunctionNov 26, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 283 AND 245MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 170 TO 200MG/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 ROOM AT FACILITY. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 3/31/2020 AND OPEN VIAL DATE IS A FEW DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:283MG/DL (B)(6) 11:36AM FASTING; RESULT 2:245MG/DL (B)(6) 11:45PM FASTING; RESULT 3:177MG/DL (B)(6) 7:34PM FASTING; RESULT 4:361MG/DL (B)(6) 5:08PM FASTING; RESULT 5:271MG/DL (B)(6) 2:59PM FASTING; RESULT 6 247MG/DL (B)(6) 10:31AM FASTING. CUSTOMER WAS DIAGNOSED WITH TYPE 1 DIABETES AND HAVE BEEN HAVING A HARD TIME WITH GETTING HIS UNDER CONTROL. HE WAS AT THE HOSPITAL BUT NOW TO GET HIM UNDER CONTROL HE HAS BEEN MOVED TO (B)(6). HE IS CURRENTL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8102882 ↗
• MalfunctionNov 15, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 135, 138 AND 217 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. CUSTOMER STATED 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 STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/25/2019 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 8075116 ↗
• MalfunctionJul 20, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem

  CONSUMER REPORTED COMPLAINT FOR BROKEN DISPLAY ACCOMPANIED BY SYMPTOMS. BLOOD GLUCOSE RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING HYPOGLYCEMIC SYMPTOMS OF CONFUSION AND SLURRED SPEECH. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. 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 NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/29/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. DAUGHTER CALLING ON BEHALF OF CUSTOMER. CUSTOMER REQUIRED 911 ON (B)(6) 2018. CUSTOMER WAS HAVING HYPOGLYCEMIC SYMPTOMS SUCH AS CONFUSION, SLURRED SPEECH. CUSTOMER WAS UNABLE TO OBTAIN RESULTS WITH OUR METER DUE TO BROKEN DISPLAY. GLUCOSE WATER IN IV PER CUSTOMER AND CUSTOMER DOESN'T RECALL THE NAME OF THE MEDICATION THAT THE EMT DID ADMINISTER VIA INJECTION. WHEN AMBULANCE ARRIVED ON (B)(6) 2018 THE BG WAS 20 MG/DL NOT FASTING WITH THE EMT METER AND 164 MG/DL NOT

  Patient problems: Confusion/ Disorientation

  MAUDE report 7707328 ↗
• MalfunctionApr 18, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER COMPLAINT OF E-0 ERROR; TEST STRIP ERROR. E-0 ERROR OCCURRED WHEN THE BLOOD SAMPLE IS ABSORBED. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2018 PRODUCED RESULT OF E-0 UPON SAMPLE OF BLOOD BEING APPLIED TO STRIP. STORAGE LOCATION OF PRODUCT IS UNDISCLOSED. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/22/2019 AND OPEN VIAL DATE IS ONE WEEK AGO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7440163 ↗