GLUCOCARD® Vital™ BLOOD GLUCOSE METER 760001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00015482760014), received between Mar 8, 2018 and Feb 22, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ARKRAY USA, INC. RECEIVED THE FOLLOWING COMPLAINT INFORMATION VIA US MAIL. IN APPROXIMATELY THE (B)(6) OF 2016, MR. (B)(6) OBTAINED A NEW GLYCOMETER, GLUCOCARD VITAL SERIAL NUMBER (B)(4). CUSTOMER CLAIMS THAT ON OR ABOUT THE FIRST WEEK OF (B)(6) 2017, THE GLYCOMETER BEGAN GIVING INACCURATE READINGS TO MR. (B)(6). CUSTOMER ALSO CLAIMS THAT ON OR ABOUT (B)(6) 2017, AS A RESULT OF IMPROPER ADMINISTRATION OF GLUCOSE, THE MR. (B)(6) BECAME ILL AND WAS HOSPITALIZED AT (B)(6) HOSPITAL IN (B)(6). THERE HE CLAIMS THAT HE SUFFERED A NUMBER OF ADVERSE SYMPTOMS AND BEGAN TO DEVELOP HALLUCINATIONS. MR. (B)(6) CLAIMS THAT HE SUFFERED THESE SYMPTOMS BECAUSE HE ADMINISTERED IMPROPER DOSES OF INSULIN BECAUSE OF THE FAILURE OF THE GLYCOMETER MANUFACTURED BY ARKRAY USA, INC. TO PROPERLY MONITOR HIS BLOOD SUGAR LEVELS AS THE GLYCOMETER WAS DESIGNED TO DO. WE ARE UNABLE TO GATHER MORE INFORMATION REGARDING THIS COMPLAINT BECAUSE WE DO NOT HAVE THE CUSTOMER'S CONTACT INFORMATION.

  Patient problems: Hypoglycemia

  MAUDE report 8363145 ↗
• MalfunctionMar 8, 2018Missing Test Results; Missing Test Results

  PATIENT DID A TEST ON SATURDAY, (B)(6) 2018 IN THE MORNING WHILE FASTING. HE RECEIVED A READING OF 41. HE DIDN'T THINK THE READING WAS ACCURATE AND TESTED AGAIN RIGHT AWAY. HE USED A DIFFERENT FINGER AND RECEIVED 219, THEN 203, ALL WITHIN 10 MINUTES. THIS IS A NEW METER THAT IS ABOUT 2-3 WEEKS OLD. STRIPS WERE OPENED 2-3 WEEKS AGO. PATIENT STORES PRODUCTS IN HIS BEDROOM. PATIENT IS NOT RECEIVING ANY OXYGEN THERAPY. DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD. USES ALCOHOL WIPES AND ALLOWS FINGERS TO DRY THOROUGHLY, USES FINGERTIP AS A TESTING SITE. SEALS THE BOTTLE CAP TIGHTLY AND IMMEDIATELY AFTER REMOVING A TEST STRIP. CHANGES LANCETS EVERY TIME HE TESTS. CUSTOMER'S WIFE STATED THAT HE DID NOT HAVE ANY SYMPTOMS ASSOCIATED WITH THE READINGS. HE DID NOT TAKE ANY MEDICATION. HE DID NOT CONTACT THE PARAMEDICS OR GO TO THE ER. HIS NORMAL GLUCOSE READINGS ARE UNKNOWN. HE TAKES HUMULIN FOR DIABETES. HE HAS IMPROVED ON HIS DIET BY CUTTING BACK CARBS AND MEASURING FOOD PORTIONS. NO PHYSICAL DAMAGE TO THE METER OR DEBRIS AROUND THE TEST STRIP PORT. THE METER LOOKS BRAND NEW. HE TESTED AGAIN TODAY AND RECEIVED A READING OF LO, THEN HE TESTED AGAIN AND RECEIVED 204 WHILE FASTING. HE DID N

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7322972 ↗