BD PHOENIX¿ NMIC-306
Report
- Report Number
- 1119779-2025-05506
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Date of Event
- November 18, 2025
- Report Date
- March 31, 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
- TX, 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, 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.
INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR LOW MIC RESULTS FOR CEFTAZIDIME/AVIBACTAM (CZA) AND MEROPENEM (MEM) WHEN USING PANEL PHOENIX NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 5254642. THE CUSTOMER RETURNED AN ISOLATE AND PHOENIX GENERATED LAB REPORTS WITH MIC RESULTS FOR ESCHERICHIA COLI FOR THE INVESTIGATION. 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 LOW MIC RESULTS FOR PANEL SKU 449292. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI 5892 TO OBSERVE FOR CZA AND MEM MIC RESULTS. NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI 5892 TO OBSERVE FOR CZA AND MEM MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH RESISTANT CZA AND SUSCEPTIBLE MEM MIC AND SIR RESULTS FOR THEIR INOCULATED ISOLATES. FOR FURTHER INVESTIGATION, DISK DIFFUSION WAS PERFORMED ON CUSTOMER RETURNED ISOLATE E. COLI 5892 FOR MEM SIR RESULTS. THE DISK DIFFUSION SHOWS E. COLI WITH RESISTANT SIR RESULTS FOR MEM. THEREFORE, THIS COMPLAINT IS CONFIRMED FOR LOW MIC MEM WITH THE CUSTOMER RETURNED ISOLATE. AS NO COMPLAINT TREND HAS BEEN IDENTIFIED, NO ACTIONS ARE INDICATED AT THIS TIME PER BD PROCEDURES. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT URINE ISOLATE (ESCHERICHIA COLI) HAD A SENSITIVE RESULT FOR THE DRUG CEFTAZIDIME/AVIBACTAM. CONVERSELY, THE USER NOTED THAT THE E-TEST RESULTS WERE RESISTANT FOR CEFTAZIDIME/AVIBACTAM DURING REPEAT TESTING. A REFERENCE LABORATORY WAS USED, AND THE CARBA-R PCR RESULT WAS SHOWING THE NEW DELHI METALLO-BETA-LACTAMASE (NDM) GENE PRESENT. THE USER STATED, "PATIENT WAS TREATED WITH INEFFECTIVE THERAPY (MEROPENEM) FOR THREE DAYS DUE TO FALSE SUSCEPTIBLE RESULT REPORTED."
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT URINE ISOLATE (ESCHERICHIA COLI) HAD A SENSITIVE RESULT FOR THE DRUG CEFTAZIDIME/AVIBACTAM. CONVERSELY, THE USER NOTED THAT THE E-TEST RESULTS WERE RESISTANT FOR CEFTAZIDIME/AVIBACTAM DURING REPEAT TESTING. A REFERENCE LABORATORY WAS USED, AND THE CARBA-R PCR RESULT WAS SHOWING THE NEW DELHI METALLO-BETA-LACTAMASE (NDM) GENE PRESENT. THE USER STATED, "PATIENT WAS TREATED WITH INEFFECTIVE THERAPY (MEROPENEM) FOR THREE DAYS DUE TO FALSE SUSCEPTIBLE RESULT REPORTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218538 | BD PHOENIX¿ NMIC-306 | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 5254642 | 30382904492923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |