TRUE METRIX PRO TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE METER (REF RE4H01P-43)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00021292006105), received between Jun 19, 2018 and Jun 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

• MalfunctionJun 19, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT OF E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE E-3 ERROR OCCURRED AFTER THE BLOOD SAMPLE WAS APPLIED. DURING THE CALL ON (B)(6) 2018, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS NOT PERFORMED AS CUSTOMER WAS NOT AT HOME AT THE TIME. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/19/2018 AND OPEN VIAL DATE IS UNDISCLOSED. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7616074 ↗