Assure® Platinum BLOOD GLUCOSE METER 500001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00015482500016), received between Mar 20, 2025 and Mar 20, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “High Readings” (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

Recent adverse event reports

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

• InjuryMar 20, 2025High Readings; High Readings

  THE PATIENT'S HUSBAND STATED HE WENT TO CHECK ON HER AND FOUND HER SOAKING WET AND UNABLE TO GET UP. AFTER GIVING HER A DRINK, HE PERFORMED A BLOOD TEST THAT SHOWED A READING OF 106. BECAUSE SHE APPEARED CONFUSED AND COULDN'T SIT UP, HE DOUBTED THE ACCURACY OF THE RESULT. HE CALLED 911 AROUND 3:35 PM AND THE PARAMEDICS ARRIVED 10 MINUTES LATER. THE PARAMEDIC TESTED THE PATIENT AND RECEIVED A READING OF 51. THEY ADMINISTERED A SUGAR SOLUTION, AND WITHIN APPROXIMATELY 10 MINUTES, SHE WAS ABLE TO SIT UP, HOLD A CONVERSATION AND EAT A PEANUT BUTTER AND JELLY SANDWICH. THE PARAMEDIC RE-TESTED HER, AND HER READING WAS 170. SHE WAS FEELING BETTER, BUT TIRED AND WAS ADVISED SHE COULD SLEEP, AND THE PARAMEDIC ADVISED THE PATIENT'S HUSBAND TO CHECK ON HER. SHE DID NOT GO TO THE HOSPITAL. ADVISED TO STOP USING METER AND STRIPS. REPLACED METER, STRIPS AND SENT RETURN LABEL.

  Patient problems: Hypoglycemia

  MAUDE report 21651796 ↗
• InjuryMar 20, 2025High Readings; High Readings

  THE PATIENT'S HUSBAND STATED HE WENT TO CHECK ON HER AND FOUND HER SOAKING WET AND UNABLE TO GET UP. AFTER GIVING HER A DRINK, HE PERFORMED A BLOOD TEST THAT SHOWED A READING OF 106. BECAUSE SHE APPEARED CONFUSED AND COULDN'T SIT UP, HE DOUBTED THE ACCURACY OF THE RESULT. HE CALLED 911 AROUND 3:35 PM AND THE PARAMEDICS ARRIVED 10 MINUTES LATER. THE PARAMEDIC TESTED THE PATIENT AND RECEIVED A READING OF 51. THEY ADMINISTERED A SUGAR SOLUTION, AND WITHIN APPROXIMATELY 10 MINUTES, SHE WAS ABLE TO SIT UP, HOLD A CONVERSATION AND EAT A PEANUT BUTTER AND JELLY SANDWICH. THE PARAMEDIC RE-TESTED HER, AND HER READING WAS 170. SHE WAS FEELING BETTER, BUT TIRED AND WAS ADVISED SHE COULD SLEEP, AND THE PARAMEDIC ADVISED THE PATIENT'S HUSBAND TO CHECK ON HER. SHE DID NOT GO TO THE HOSPITAL. ADVISED TO STOP USING METER AND STRIPS. REPLACED METER, STRIPS AND SENT RETURN LABEL.

  Patient problems: Hypoglycemia

  MAUDE report 21651699 ↗