BD PHOENIX¿ NMIC-311
Report
- Report Number
- 1119779-2026-00221
- Event Type
- Malfunction
- Date Received
- February 19, 2026
- Date of Event
- December 5, 2025
- Report Date
- March 31, 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
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WHEN USING PANEL PHOENIX NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 5280898. 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 KLEBSIELLA AEROGENES, 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, KLEBSIELLA AEROGENES A13048 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, KLEBSIELLA AEROGENES A13048 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 A PATIENT ISOLATE (ESCHERICHIA COLI) HAD FALSE RESISTANCE (HIGH MIC) WITH THE DRUG ERTAPENEM. THE USER STATED AN OVERALL INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING STATING THAT THE ISOLATE IS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ISOLATE (ESCHERICHIA COLI) HAD FALSE RESISTANCE (HIGH MIC) WITH THE DRUG ERTAPENEM. THE USER STATED AN OVERALL INCREASE IN CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). THE USER VERIFIED THE FINAL RESULT USING REPEAT TESTING STATING THAT THE ISOLATE IS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155298 | BD PHOENIX¿ NMIC-311 | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 5280898 | 30382904494521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |