BD PHOENIX¿ PID

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL PID (CATALOG NUMBER 448008) BATCH NUMBER 5114581. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS SHOWING STAPHYLOCOCCUS AUREUS AND STAPHYLOCOCCUS EPIDERMIDIS IDENTIFICATIONS FOR THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. TO INVESTIGATE, PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE S. EPIDERMIDIS POS 3644 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY, THIS COMPLAINT IS NOT CONFIRMED.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PID A PATIENT ISOLATE (STAPHYLOCOCCUS EPIDERMIDIS) WAS MISIDENTIFIED AS STAPHYLOCOCCUS AUREUS OR STAPHYLOCOCCUS SAPROPHYTICUS. THE USER VERIFIED THE FINAL RESULT BY PERFORMING REPEAT TESTING USING A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 11 OF 12.

Additional Manufacturer Narrative

E1. INITIAL REPORTER ADDR 1: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PID A PATIENT ISOLATE (STAPHYLOCOCCUS EPIDERMIDIS) WAS MISIDENTIFIED AS STAPHYLOCOCCUS AUREUS OR STAPHYLOCOCCUS SAPROPHYTICUS. THE USER VERIFIED THE FINAL RESULT BY PERFORMING REPEAT TESTING USING A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 11 OF 12.