TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER (REF RE4099-45)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00021292008697), received between Feb 2, 2017 and Feb 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 266 AND 444 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 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. DURING THE CALL ON (B)(6) 2017, 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 11/30/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE CUSTOMER IS ON INSULIN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 277MG/DL, (B)(6) 2017 01:29 PM, FASTING:YES. A 143MG/DL, (B)(6) 2017 10:05 AM, FASTING:YES. A 248MG/DL, (B)(6) 2017 05:39 PM, FASTING:YES. A 191MG/DL, (B)(6) 2017 01:02 PM, FASTING:YES. A 94MG/DL, (B)(6) 2017 09:52 AM, FASTING:YES. MEMORY CONCERNS:444MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6297508 ↗