FDA Adverse Event Malfunction Summary report: N

BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

MDR report key: 24416041 · Received February 23, 2026

Report

Report Number: 1119779-2026-00236
Event Type: Malfunction
Date Received: February 23, 2026
Date of Event: January 29, 2026
Report Date: February 23, 2026
Manufacturer: BECTON DICKINSON & CO. (SPARKS)
Product Code: LON
UDI-DI: 00382904481001
PMA / PMN Number: SEE H11
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER INDICATING THAT NO PATIENT RESULTS WERE AFFECTED. THIS COMPLAINT IS NOT MDR REPORTABLE. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THE PREVIOUS MFR REPORT # 1119779-2026-00236 SHOULD BE CONSIDERED CANCELLED.

Additional Manufacturer Narrative · 0

E1. INITIAL REPORTER PHONE #: (B)(6). E1. INITIAL REPORTER ADDR 1: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020321, K020322, K020323, K040099, AND K131331. 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 · 0

IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD IMPROPER RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
479797	BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION	LON	BECTON DICKINSON & CO. (SPARKS)			00382904481001

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown