Alere Triage® 97300EURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00899722002740), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 16, 2018Low Test Results; Low Test Results

  A PATIENT EXPERIENCED RESPIRATORY DISTRESS AND WAS TESTED FOR CARDIAC MARKERS USING THE TRIAGE SYSTEM. THE TRIAGE SYSTEM PRODUCED RESULTS OF TNI= <0.05 NG/ML AND BNP= 96 PG/ML. AS THE TRIAGE TNI RESULT WAS DETERMINED TO BE NORMAL BY THE CUSTOMER, THE PATIENT WAS TAKEN TO THE EMERGENCY UNIT OF A HOSPITAL INSTEAD OF A HOSPITAL WITH A CARDIOLOGY UNIT. THE PATIENT WAS TESTED IN THE EMERGENCY UNIT BY ANOTHER SERVICE AN HOUR LATER AND RECEIVED RESULTS OF TNI= 0.0792 NG/ML AND BNP= 387 PG/ML (NORMAL TNI CUTOFF FOR THIS INSTRUMENT= 0.034 NG/ML). AS THIS TNI RESULT WAS ABNORMAL, THE DECISION WAS MADE TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL SPECIALIZED IN CARDIOLOGY. THE PATIENT'S DIAGNOSIS PRIOR TO TRANSFER WAS HEART FAILURE AND CORONARY DISTRESS. AS OF MARCH 29, 2018, THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7434896 ↗