ASSURE® Prism Blood Glucose Test Strips 532050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00015482532505), received between Feb 10, 2023 and Feb 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “High 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. How this data works · Data updated Oct 13, 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 10, 2023High Readings; High Readings

  THEY HAVE BEEN HAVING ISSUES WITH THESE GLUCOMETERS. THEY HAVE HAD THREE OCCURRENCES IN THE PAST FEW WEEKS WHERE THE READINGS HAVE BEEN OFF. REPORTER WAS ON ONE CALL WHERE THE PATIENT'S FREE STYLE LIBRE READ 55 AND THE PRISM READ 98. THEY RE-CHECKED AFTER THEY STARTED AN IV AND THE PRISM READ 102. AFTER ARRIVAL TO THE HOSPITAL, THEY CHECKED AGAIN, AND IT WAS NOW 33 ON ANOTHER METER. THEY SWAPPED TO A DIFFERENT MONITOR ON THAT AMBULANCE, AND THEY HAD A SUBSEQUENT CALL WHERE THE PATIENT'S OWN WAS READING 800, AND THE PRISM READ 400. OVER THE WEEKEND, THEY HAD A CALL WHERE THE PATIENT READ 155, BUT THEY WERE NOT ACTING LIKE THEIR GLUCOSE WAS 155, SO THEY WERE TREATED, AND TESTED AGAIN AND THE READING WAS 90. ALL READINGS WERE PERFORMED WITHIN FIVE MINUTES OF EACH OTHER. THE CALLER STATED THE METERS ARE ALWAYS READING TOO HIGH. VERIFIED THEY CHANGE THE LANCETS EACH TIME THEY TEST. THEY USE ALCOHOL TO CLEAN FINGERS AND ALLOW FINGER TO DRY COMPLETELY. PATIENT WAS NOT RECEIVING ANY OXYGEN THERAPY. PATIENT DOESN'T HAVE TROUBLE GETTING A BLOOD SAMPLE. THE METER AND TEST STRIPS ARE STORED TOGETHER IN THE BACK OF THE AMBULANCE IN A TEMPERATURE-CONTROLLED ENVIRONMENT. REPLACED METER, STRIPS AN

  Patient problems: Hypoglycemia

  MAUDE report 16356248 ↗
• InjuryFeb 10, 2023Imprecise or Erratic Results; Imprecise or Erratic Results

  CUSTOMER HAS BEEN HAVING ISSUES WITH THESE GLUCOMETERS. THEY STATED THEY HAVE HAD THREE OCCURRENCES IN THE PAST FEW WEEKS WHERE THE READINGS HAVE BEEN OFF. THEY RECEIVED A CALL FOR PATIENT EXPERIENCING DIABETIC PROBLEMS. HE HAD FALLEN. HE WAS ALERT BUT CONFUSED. THE PATIENT'S SON HAD GIVEN HONEY BEFORE THE AMBULANCE ARRIVED. THEY CHECKED THE PATIENT'S SUGAR. THEY RECEIVED A READING OF 155. THE PARAMEDICS GAVE HIM GLUCOSE GEL, FOOD (SANDWICH) AND JUICE. THEY CHECKED HIM AGAIN AND THE METER READ 90, WHICH THEY FEEL WAS INCORRECT AND SHOULD HAVE BEEN HIGHER AFTER THE HONEY, THE GLUCOSE GEL, SO THEY THINK THE METER READ TOO HIGH WHEN HE WAS ORIGINALLY TESTED, AND HE WAS LOW. THE PATIENT BECAME ALERT, AND HE WAS ABLE TO ANSWER ALL THEIR QUESTIONS. HE CAME BACK TO NORMAL. HE WAS NOT TRANSPORTED TO THE HOSPITAL. VERIFIED THEY CHANGE THE LANCETS EACH TIME THEY TEST. THEY USE ALCOHOL TO CLEAN FINGERS AND ALLOW FINGER TO DRY COMPLETELY. PATIENT WAS NOT RECEIVING ANY OXYGEN THERAPY. PATIENT DOESN'T HAVE TROUBLE GETTING A BLOOD SAMPLE. THE METER AND TEST STRIPS ARE STORED TOGETHER IN THE BACK OF THE AMBULANCE IN A TEMPERATURE-CONTROLLED ENVIRONMENT. REPLACED METER, STRIPS AND SENT RETURN LABEL

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 16355728 ↗