REMEL

Description of Event or Problem

SPECIFIC AGAR PLATE USED WITHIN THE LABORATORY GREW A MOLD NOT REPRESENTATIVE OF THE PATIENT'S CULTURE. THE SAME MOLD WAS RECOVERED ON ADDITIONAL PLATES OF THE SAME LOT FROM DIFFERENT PATIENTS AND COLLECTION LOCATIONS, INDICATING CONTAMINATION FROM THE MANUFACTURER. UNFORTUNATELY, THERE IS NOT AN INSTRUMENT REPORT GENERATED. MOLD IDENTIFICATION IS MANUAL METHOD BASED ON TECHNOLOGIST MICROSCOPY. THE MOLD WAS IDENTIFIED PER OUR INTERNAL PROTOCOLS FOR FUNGI IDENTIFICATION. ENVIRONMENTAL CONCERN HAS BEEN RULED OUT AND NO OTHER PRODUCTS IN OUR LAB HAVE BEEN IDENTIFIED AS IMPACTED. ERRONEOUS LAB RESULTS REDACTED FROM PATIENT CHARTS. THIS TEAM NOTIFIED REP VIA EMAIL AND PHONE OF THE ISSUE, INCLUDING MEDWATCH REPORT NUMBER AND ALL DETAILS FROM THIS REPORT. MANUFACTURER RESPONSE FOR AGAR PLATE, (BRAND NOT PROVIDED) (PER SITE REPORTER). WAITING TO HEAR IF SAMPLE IS AVAILABLE AND IF REP WOULD LIKE IT SENT TO THEM.