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GLUCOCARD® Vital™ BLOOD GLUCOSE TEST STRIPS 760050Recalls & reported problems

Arkray USA, Inc. · Blood Glucose Test Strips · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00015482760502), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Missing Test Results” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Missing Test Results1

Patient problems

  • Hyperglycemia1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 25, 2018Missing Test Results; Missing Test Results

    CUSTOMER TOOK A READING YESTERDAY EVENING AROUND 6 PM AND RECEIVED LO, THEN FOUR MINUTES LATER HE TOOK ANOTHER TEST AND RECEIVED 474. HE DIDN'T TRUST THE READING, SO HE CALLED THE AMBULANCE. THE AMBULANCE ARRIVED AND TOOK HIS BLOOD SUGAR AND THEY RECEIVED 344. WHILE HE WAS INSIDE THE AMBULANCE, THEY ATTEMPTED TO ADMINISTRATE AN IV BUT WAS UNSUCCESSFUL. AFTER HE ARRIVED AT THE HOSPITAL THEY WERE ABLE TO CONNECT HIM TO AN IV. THE IV WASN'T BRINGING HIS GLUCOSE DOWN FAST ENOUGH SO THEY TREATED HIM WITH FIVE UNITS OF FAST ACTING INSULIN. THEY CHECKED HIS BLOOD SUGAR AGAIN AND NOTICED IT WASN'T DECREASING AND TREATED HIM WITH A SECOND ROUND OF FIVE UNITS OF FAST ACTING INSULIN. THE LAST TREATMENT BROUGHT HIS READING DOWN TO ABOUT 274MG. THEN THEY WERE ABLE TO DISCHARGE HIM. VERIFIED THE CUSTOMER HAS HAD THE METER FOR ONE YEAR. CUSTOMER OPENED TEST STRIPS ABOUT FOUR DAYS AGO. HE IS NOT RECEIVING ANY OXYGEN THERAPY. CALLER DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD. STORES BOTH HIS METER AND TEST STRIPS IN THE LIVING ROOM. VERIFIED HE SEALS THE TEST STRIPS IMMEDIATELY AND TIGHTLY AFTER REMOVING A TEST STRIP. HE WASHES HIS HANDS WITH SOAP AND WATER AND DRIES THEM THOROUGHLY. HE USES HI

    Patient problems: Hyperglycemia

    MAUDE report 7905565 ↗

Other GLUCOSE OXIDASE, GLUCOSE devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.