MalfunctionLQL
BD PHOENIX PID
Received Feb 26, 2026 · Event occurred Jan 29, 2026
Report 1119779-2026-00267 · MDR key 24455014
Device
Generic name
Gram Positive Identification Panel
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
448008
Lot number
5192138
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 WAS MISIDENTIFIED AS STAPHYLOCOCCUS AUREUS. THE USER VERIFIED THE FINAL RESULT USING BACTERIAL CULTURE. THE USER STATED THE COLONY MORPHOLOGY HAD WHITE COLONIES AND WAS NON HEMOLYTIC. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.