FDA Adverse Event Malfunction Summary report: N

PANEL PHOENIX NMIC-312

MDR report key: 24639608 · Received March 19, 2026

Report

Report Number: 1119779-2026-00432
Event Type: Malfunction
Date Received: March 19, 2026
Date of Event: February 23, 2026
Report Date: March 19, 2026
Manufacturer: BECTON DICKINSON & CO. (SPARKS)
Product Code: LON
UDI-DI: 30382904490820
PMA / PMN Number: SEE H11
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA/510(K)#: K020322, K023444, K023634, K023858, K033458, K042932, K060214, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K062945, K063486, K063573, K063811, K063824, K123404, K132674, K132909, K163637, K173252, K173523, K181665, AND K233986. 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 PANEL PHOENIX NMIC-312 A PATIENT ISOLATE (SERRATIA MARCESCENS) HAD INTERMEDIATE OR RESISTANT TO IMIPENEM DESPITE BEING SENSITIVE TO MOST OTHER DRUGS ON THE PANEL INCLUDING ERTAPENEM, CEFEPIME, AND CEFTRIAXONE. THE USER PERFORMED REPEAT TESTING GIVING INTERMEDIATE RESULTS. IT IS TO BE NOTED THAT A KIRBY-BAUER OR E-TEST WAS PERFORM ON THE CARBAPENEMS THAT HAD BEEN INTERMEDIATE OR RESISTANT RESULTS. THE USER ALSO STATED THAT EACH ISOLATE TESTED SENSITIVE TO IMIPENEM BY KIRBY BAUER OR E-TEST. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 2 OF 2.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
697369	PANEL PHOENIX NMIC-312	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION	LON	BECTON DICKINSON & CO. (SPARKS)		5324466	30382904490820

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown