TRUEtrack TRUEtrack Blood Glucose Meter Medidor de Glucosa en la SangreRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847717034009), received between May 22, 2017 and May 22, 2017 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K032657); they may or may not involve this specific model.

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.

• MalfunctionMay 22, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 68 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 110 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 103 MG/DL USING TRUETRACK METER AND 115 MG/DL USING TRUETRACK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6581989 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032657. One submission often covers many models, so check the product and lot details in each record.

• Z-2881-2016 · Jun 28, 2016 · Open, Classified
  TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50
• Z-0910-2014 · Oct 2, 2013 · Terminated
  MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 333
• Z-1140-2013 · Feb 25, 2013 · Terminated
  Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole