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TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER (REF RE4023-01)Recalls & reported problems

Trividia Health, Inc. · fred's Pharmacy TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER · Class 2

All models of TRUE METRIX (31)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00021292007256), received between Feb 14, 2017 and Aug 3, 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

Device problems

  • High Test Results2

Patient problems

  • Nausea1
  • No Known Impact Or Consequence To Patient1
  • Weakness1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 3, 2018High Test Results; High Test Results

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING WEAK AND NAUSEOUS. CUSTOMER STATED SHE WOULD SEEK MEDICAL ATTENTION. CUSTOMER DID NOT PROVED EXPECTED BLOOD GLUCOSE TEST RESULT RANGE OR RESULTS OF CONCERN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Patient problems: Nausea; Weakness

    MAUDE report 7747895 ↗
  • MalfunctionFeb 14, 2017High Test Results; High Test Results

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 183, 178 AND 188 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 130 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/25/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6). MEMORY CONCERNS: CUSTOMER CONCERNED WITH ALL RESULTS. THE CUSTOMER REFUSES A REPLACEMENT WITH ANOTHER TRUE METRIX METER AND HUNG UP THE PHONE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6328380 ↗

Other System, Test, Blood Glucose, Over The Counter devices

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Sources and updates

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