Assure® Platinum BLOOD GLUCOSE TEST STRIPS 500050 500100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00015482500504), received between Oct 29, 2019 and Nov 29, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Low 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2022Low Readings; Low Readings

  METER WAS PURCHASED AND PLACED INTO SERVICE IN (B)(6) 2022. CALLER STATED THEY WERE CALLED ON (B)(6) 2022 REGARDING A PATIENT WITH DIABETIC ISSUES. WHEN EMS ARRIVED, PATIENT WAS NEARLY UNCONSCIOUS. THE PATIENT'S MOTHER STATED THAT SHE DID NOT KNOW WHAT LED TO THE PATIENT BEING IN THIS STATE AND DID NOT KNOW IF HE HAD EATEN OR TAKEN INSULIN. CALLER REPORTED THAT THEY DID A TEST WITH THE PRISM AND RECEIVED A READING OF 240. THEY THEN STARTED IV THERAPY TO TREAT PATIENT FOR POSSIBLE DIABETIC KETOACIDOSIS (DKA) DUE TO PATIENT'S HISTORY AND SIGNS/SYMPTOMS, BUT THE BLOOD GLUCOSE READINGS DIDN'T SUPPORT THE DIAGNOSIS. CALLER STATED THEY THEN PERFORMED ANOTHER TEST WITH THE PRISM AND RECEIVED A READING OF 460. PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL (B)(6) WHERE THEY TESTED PATIENT WITH THE NOVA STATSTRIP GLUCOMETER, AND THEY RECEIVED TWO CONSECUTIVE "HIGH" READINGS. THE HOSPITAL THEN TESTED VENOUS BLOOD AND RECEIVED A GLUCOSE LEVEL READING OF 770. PATIENT WAS THEN TREATED BY THE HOSPITAL, BUT THE COURSE OF THEIR TREATMENT IS UNKNOWN. CALLER STATED THIS WAS THE FIRST TIME USING THIS DEVICE AND IS CONCERNED THAT IT IS NOT ACCURATE. REPLACED METER, STRIPS AND SENT RETURN LABEL.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 15876053 ↗
• InjuryNov 18, 2022Low Readings; Low Readings

  METER WAS PURCHASED AND PLACED INTO SERVICE IN AUGUST 2022. CALLER STATED THEY WERE CALLED ON (B)(6) 2022 REGARDING A PATIENT WITH DIABETIC ISSUES. WHEN EMS ARRIVED, PATIENT WAS NEARLY UNCONSCIOUS. THE PATIENT'S MOTHER STATED THAT SHE DID NOT KNOW WHAT LED TO THE PATIENT BEING IN THIS STATE AND DID NOT KNOW IF HE HAD EATEN OR TAKEN INSULIN. CALLER REPORTED THAT THEY DID A TEST WITH THE PRISM AND RECEIVED A READING OF 240. THEY THEN STARTED IV THERAPY TO TREAT PATIENT FOR POSSIBLE DIABETIC KETOACIDOSIS (DKA) DUE TO PATIENT'S HISTORY AND SIGNS/SYMPTOMS, BUT THE BLOOD GLUCOSE READINGS DIDN'T SUPPORT THE DIAGNOSIS. CALLER STATED THEY THEN PERFORMED ANOTHER TEST WITH THE PRISM AND RECEIVED A READING OF 460. PATIENT WAS THEN TRANSPORTED TO THE HOSPITAL (B)(6) WHERE THEY TESTED PATIENT WITH THE NOVA STATSTRIP GLUCOMETER, AND THEY RECEIVED TWO CONSECUTIVE "HIGH" READINGS. THE HOSPITAL THEN TESTED VENOUS BLOOD AND RECEIVED A GLUCOSE LEVEL READING OF 770. PATIENT WAS THEN TREATED BY THE HOSPITAL, BUT THE COURSE OF THEIR TREATMENT IS UNKNOWN. CALLER STATED THIS WAS THE FIRST TIME USING THIS DEVICE AND IS CONCERNED THAT IT IS NOT ACCURATE. REPLACED METER, STRIPS AND SENT RETURN LABEL.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 15824133 ↗
• MalfunctionOct 29, 2019Missing Test Results; Missing Test Results

  FACILITY HAS HAD THE METER FOR 6-9 MONTHS. THE SERIAL NUMBER IS WIPED OFF. ASSIGNED TEMPORARY SERIAL NUMBER (B)(4). THE NURSE PERFORMED BACK TO BACK BLOOD TESTS AND RECEIVED 24, THEN RECEIVED 94 LESS THAN A MINUTE A PART. THEY DID NOT PERFORM A CONTROL SOLUTION TEST AS THE CALLER DID NOT HAVE CONTROL SOLUTION. PATIENT WAS STABLE AND DID NOT NEED MEDICAL ATTENTION. THE READINGS PROVIDED FELL IN ZONE C ON PARKES CONSENSUS GRID. REPLACED METER, TEST STRIPS AND SENT RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9249909 ↗
• MalfunctionOct 29, 2019Missing Test Results; Missing Test Results

  FACILITY HAS HAD THE METER FOR 6-9 MONTHS. NO DEBRIS AROUND THE TEST STRIP PORT. AROUND 7 AM THE NURSE PERFORMED A BLOOD TEST ON A PATIENT. THE FIRST READING WAS LO AND THE SECOND READING WAS 110. READINGS WERE PERFORMED ABOUT ONE MINUTE A PART. THE FACILITY DID NOT PERFORM A CONTROL SOLUTION TEST AS THE CALLER DID NOT HAVE CONTROL SOLUTION. SERIAL NUMBER IS RUBBED OFF. ASSIGNED TEMPORARY SERIAL (B)(4). THE PATIENT WAS STABLE AND NEEDED NO MEDICAL INTERVENTION. THEY STORE THE METER AND STRIPS ON A MED CART. THE READINGS PROVIDED FELL IN ZONE C ON PARKES CONSENSUS GRID. REPLACED METER, TEST STRIPS AND SENT RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9249820 ↗