BD PHOENIX¿ YEAST ID
Received Jun 30, 2025 · Event occurred Jun 10, 2025
Report 1119779-2025-00749 · MDR key 22365386
Device
Generic name
Kit, Identification, Yeast
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
448316
Lot number
4213971
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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¿ YEAST ID A PATIENT ISOLATE (NAKASEOMYCES GLABRATUS PREVIOUSLY KNOWN AS CANDIDA GLABRATA) WAS MISIDENTIFIED AS PICHIA FERMENTANS PREVIOUSLY KNOWN AS CANDIDA FIRMETARIA. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF CANDIDA GLABRATA WHEN USING PHOENIX PANEL YEAST ID (CATALOG NUMBER 448316) BATCH NUMBER 4213971. RETURN PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS WERE NOT AVAILABLE FOR THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT A DIFFERENT BATCH NUMBER WERE TESTED USING QC CANDIDA GLABRATA ISOLATE (A2950) ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS TESTED RETURNED THE CORRECT IDENTIFICATION FOR THEIR INOCULATED ISOLATES. THIS COMPLAINT IS NOT CONFIRMED. 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. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID A PATIENT ISOLATE (NAKASEOMYCES GLABRATUS PREVIOUSLY KNOWN AS CANDIDA GLABRATA) WAS MISIDENTIFIED AS PICHIA FERMENTANS PREVIOUSLY KNOWN AS CANDIDA FIRMETARIA. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.