TRUE METRIX PRO TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER FOR MULTIPLE PATIENTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00021292006099), received between Jun 11, 2018 and Oct 30, 2018 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 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 252, 364, 219, 222 AND 220 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 160 MG/DL THE CUSTOMER IS USING TRUEMETRIX PRO METER; CUSTOMER WAS INFORMED THAT METER IS FOR MULTI PATIENT USE AND WILL REPLACE WITH TRUEMETRIX METER. 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/20/2020 AND OPEN VIAL DATE IS 10/10/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8021774 ↗
• MalfunctionJun 11, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. RN IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF FEELING TIRED. 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 BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. NURSE CALLED IN TO ASK WHAT DOES HI MEANS, INSTRUCTED NURSE THAT IT MEANS THAT THE BLOOD SUGAR MAY BE OVER 600 MG/DL . NURSE CONFIRMS THAT THE METER WORKS FINE ON OTHER PATIENTS. NURSE STATES THAT THE CUSTOMER HAD SYMPTOMS OF HIGH BLOOD SUGAR, SHE WAS TAKING CARE OF THAT, COULD NOT CONTINUE TO TROUBLE SHOOT.

  Patient problems: Fatigue

  MAUDE report 7588260 ↗