EPLEX
Received May 2, 2025 · Event occurred Feb 2, 2025
Report 21949700 · MDR key 21949700
Device
Generic name
Fungal Organisms, Nucleic Acid-based Assay
Manufacturer
Genmark Diagnostics, Inc.Model number
BCID-GPLot 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.