inforMED
MalfunctionJQX

BD PHOENIX¿ AP

Received Apr 9, 2026 · Event occurred Mar 16, 2026

Report 1119779-2026-00634 · MDR key 24832420

Device

Generic name

Nephelometer, For Clinical Use

Catalog number

448010

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¿ AP THE USER STATED THAT THE INSTRUMENT WAS CONTAMINATED, CAUSING FALSELY RESISTANT ERTAPENEM RESULTS ON THE DOWNSTREAM INSTRUMENT. THE AP INSTRUMENT TUBING WAS INCORRECTLY INSTALLED, ONCE REPLACE DOWNSTREAM RESULTS WERE IMPROVED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.