TRUEbalance TRUEbalance 10 Blood Glucose Test StripsRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00021292007942), received between Feb 22, 2017 and Feb 22, 2017 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K090495); 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. How this data works · Data updated Oct 13, 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 22, 2017Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 48 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 92 MG/DL. AT THE TIME OF CALL ON (B)(6) 2017 , THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. THE CUSTOMER STATED SHE DID NOT FEEL ANY HYPOGLYCEMIC SYMPTOMS AT THE TIME OF RECEIVING LOW RESULT OF 48 MG/DL (FASTING) ON (B)(6) 2017. 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 09/30/2018 AND OPEN VIAL DATE AT TIME OF CALL IS THREE WEEKS. CUSTOMER STATED SHE HAS NOT HAD ANY RECENT CHANGES IN DIET, EXERCISE, OR MEDICATIONS. CUSTOMER STATED SHE TAKES GLIPIZIDE AND ACTOS FOR DIABETES MANAGEMENT. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): 87MG/DL (B)(6) 2017 10:39 PM FASTING:YES; 85MG/DL (B)(6) 2017 07:07 AM FASTING:YES; 70MG/DL (B)(6) 2017 07:57 AM FASTING:YES; 72M

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349274 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090495. One submission often covers many models, so check the product and lot details in each record.

• Z-2883-2016 · 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-0909-2014 · Oct 2, 2013 · Terminated
  MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 3