FDA Adverse Event Malfunction Summary report: N

BD PHOENIX¿ NMIC-306

MDR report key: 25085979 · Received May 5, 2026

Report

Report Number: 1119779-2026-00761
Event Type: Malfunction
Date Received: May 5, 2026
Date of Event: April 3, 2026
Report Date: April 22, 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

E1. INITIAL REPORTER PHONE #: (B)(6). 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¿ PMIC/ID-107 A PATIENT ISOLATE HAD A HIGH MIC (FALSE RESISTANT) RESULT FOR THE DRUG ERTAPENEM BUT WHEN REPEATED THE RESULT WAS SENSITIVE. THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING WITH A REFERENCE LABORATORY. THE USER NOTED ISOLATE IDENTIFICATIONS OF KLEBSIELLA PNEUMONIAE OR ESCHERICHIA COLI. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
206451	BD PHOENIX¿ NMIC-306	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION	LON	BECTON DICKINSON & CO. (SPARKS)		6013345	30382904492923

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown