inforMED
MalfunctionPEO

EPLEX

Received May 2, 2025 · Event occurred Feb 2, 2025

Report 21949700 · MDR key 21949700

Device

Generic name

Fungal Organisms, Nucleic Acid-based Assay

Model number

BCID-GP

Lot number

10238108

Product problems

  • False Negative Result
  • Non Reproducible Results

Patient

NA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

BLOOD CULTURE ID (BCID) WAS RESULTED AS STAPHYLOCOCUS AUREUS DETECTED, WITH A MECA RESISTANCE MARKER AS NOT DETECTED. MECA IS A MARKER FOR METHICILLIN RESISTANCE IN STAPHYLOCOCCUS. UPON TRADITIONAL CULTURE WORKUP, IT WAS DETERMINED THAT THIS ISOLATE WAS A METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, WHICH CONTRADICTS THE NOT DETECTED MECA RESULT PREVIOUSLY REPORTED. INTERNAL INVESTIGATION ENSUED REGARDING THE NEGATIVE MECA RESULT. AT THE SAME TIME, OUR FACULTY BEGAN TO RECEIVE REPORTS OF NATION-WIDE ISSUES WITH THE BCID PRODUCT AND THE POTENTIAL INCORRECT RESULTS FOR MECA. THE INTERNAL DECISION WAS MADE TO STOP TESTING FOR POSITIVE BLOOD CULTURES WITH A GRAM POSITIVE COCCI IN CLUSTERS.