BD PHOENIX¿ NMIC-311
Report
- Report Number
- 1119779-2026-00190
- Event Type
- Malfunction
- Date Received
- February 17, 2026
- Date of Event
- January 22, 2026
- Report Date
- April 23, 2026
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904494521
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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, K022129, K023444, K023634, K023858, K024153, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033458, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, AND K06382. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS FOR CARBAPENEMS WITH ENTEROBACTERIACEAE WHEN USING PANEL PHOENIX NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 5287264. THE CUSTOMER RETURNED A SUMMARY OF RESULTS AND BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER NOTED HIGH MIC RESULTS FOR IMIPENEM (IPM) AND ERTAPENEM (ETP) WITH ENTEROBACTER CLOACAE, KLEBSIELLA PNEUMONIAE AND ESCHERICHIA COLI WHEN USING THE COMPLAINT BATCH. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS ANALYZED, AND NO CURRENT TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. HISTORICAL TRENDING WAS REVIEWED AND THERE WERE NO TRENDS FOR HIGH MIC RESULTS FOR PANEL SKU 449452. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES KLEBSIELLA PNEUMONIAE 11000, ENTEROBACTER CLOACAE COMPLEX 11061 AND ESCHERICHIA COLI 11002 TO OBSERVE FOR IPM AND ETP MIC RESULTS. NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES KLEBSIELLA PNEUMONIAE 11000, ENTEROBACTER CLOACAE COMPLEX 11061 AND ESCHERICHIA COLI 11002 TO OBSERVE FOR IPM AND ETP MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH SATISFACTORY SUSCEPTIBLE IPM AND ETP SIR AND MIC RESULTS, THEREFORE THIS COMPLAINT IS NOT CONFIRMED. BD R&D PERFORMED A BIOCHEMICAL ANALYSIS OF THE CUSTOMER PROVIDED BINARY FILES. THERE WERE NO RESULTS IN THE CHEMICAL REACTIONS THAT STOOD OUT TO BE A DEFINITIVE ROOT CAUSE OF THE FALSE RESISTANCE; IN ADDITION, THERE WERE NO SIGNS OF CONTAMINATION. LAST, ISOLATE CHARACTERISTICS OF TRUE RESISTANCE TO CARBAPENEMS WAS ALSO FOUND IN THE CUSTOMER'S BINARIES. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 PATIENT ISOLATES ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, AND KLEBSIELLA PNEUMONIAE HAVE HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS ERTAPENEM, MEROPENEM, AND IMIPENEM. THE USER STATED THERE HAS BEEN AN INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE) RATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 5 OF 6.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 PATIENT ISOLATES ENTEROBACTER CLOACAE COMPLEX, ESCHERICHIA COLI, AND KLEBSIELLA PNEUMONIAE HAVE HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS ERTAPENEM, MEROPENEM, AND IMIPENEM. THE USER STATED THERE HAS BEEN AN INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE) RATES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 5 OF 6.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235043 | BD PHOENIX¿ NMIC-311 | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 5287264 | 30382904494521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |