MalfunctionJQX
BD PHOENIX¿ AP
Received Apr 13, 2026 · Event occurred Mar 16, 2026
Report 1119779-2026-00667 · MDR key 24856905
Device
Generic name
Nephelometer, For Clinical Use
Manufacturer
Becton Dickinson & Co. (sparks)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
E1. INITIAL REPORTER PHONE #: (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¿ AP THE INSTRUMENT WAS FOUND TO BE CONTAMINATED RESULTING IN INCORRECT RESISTANCE ON THE DOWNSTREAM INSTRUMENTATION. THE USER NOTED REPLACING THE DEVICE'S CONSUMABLES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.