PANEL PHOENIX NMIC-312
Report
- Report Number
- 1119779-2026-00433
- 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
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.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC-312 A PATIENT ISOLATE (KLEBSIELLA VARIICOLA) HAD INTERMEDIATE OR RESISTANT (HIGH MIC) RESULTS 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 |
|---|---|---|---|---|---|---|---|
| 697367 | 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 |