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GLUCOCARD® Shine Blood Glucose Monitoring System 540001Recalls & reported problems

Arkray USA, Inc. · The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes. · Class 2

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 00015482540012), received between Mar 8, 2021 and Dec 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low 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

  • Low Test Results2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionDec 10, 2021Low Test Results; Low Test Results

    CALLER WAS NOT ABLE TO FIND LOT NUMBER. WE DID A CS TEST AND THE METER READ BELOW THE RANGE. THEY JUST OPENED CS TODAY. REPLACED METER, STRIPS, CS AND SENT RL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12974284 ↗
  • MalfunctionMar 8, 2021Low Test Results; Low Test Results

    THE CUSTOMER WAS WORRIED ABOUT THE ACCURACY OF HER GLUCOCARD SHINE METER AND PERFORMED CONTROL SOLUTION TESTS WITH TWO DIFFERENT BOTTLES OF TEST STRIPS. SHE HAD PERFECT TECHNIQUE FOR PERFORMING THE CONTROL SOLUTION TESTING; HOWEVER, THE LEVEL ONE CONTROL SOLUTION TESTS WERE ON AVERAGE 20 POINTS BELOW THE RANGE ON BOTH BOTTLES OF TEST STRIPS. LEVEL 1 RANGE LISTED ON BOTH BOTTLES OF TEST STRIPS IS 118-159MG/DL, BUT READING ON BOTH BOTTLES OF TEST STRIPS ARE LOW AT 85-95MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11431985 ↗

Other SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER devices

All SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER devices →

Sources and updates

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