FDA Adverse Event Malfunction Summary report: N

BD PHOENIX¿ NMIC-306

MDR report key: 24778289 · Received April 3, 2026

Report

Report Number: 1119779-2026-00599
Event Type: Malfunction
Date Received: April 3, 2026
Date of Event: March 11, 2026
Report Date: March 16, 2026
Manufacturer: BECTON DICKINSON & CO. (SPARKS)
Product Code: LON
UDI-DI: 30382904492923
PMA / PMN Number: SEE H11
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, 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, K022129, K023444, K023634, K023858, K024153, 031530, K031699, K031912, K032299, K032567, K032655, K032675, K033362, K033458, K033558, K033560, K041384, K042932, K052269, K060214, 060217, K060257, K060444, K060447, K061327, K061355, K061867, K062207, K062944, K063301, AND K06348. 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¿ NMIC-306 PATIENT ISOLATE HAD A HIGH MIC (FALSE RESISTANT) RESULT FOR THE CARBAPENEM DRUG CLASS BUT WHEN REPEATED THE RESULT WAS SENSITIVE. THE USER STATED THE DRUG ERTAPENEM IS RESISTANT, BUT THE DRUG MEROPENEM IS SENSITIVE. THE USER PERFORMED REPEAT TESTING. IT IS ALSO TO BE NOTED THAT THE UPSTREAM INSTRUMENT WAS FOUND TO BE CONTAMINATED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
840311	BD PHOENIX¿ NMIC-306	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION	LON	BECTON DICKINSON & CO. (SPARKS)		5350972	30382904492923

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown