BD PHOENIX¿ NMIC-306
Report
- Report Number
- 1119779-2025-05171
- Event Type
- Malfunction
- Date Received
- October 28, 2025
- Date of Event
- October 3, 2025
- Report Date
- February 2, 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
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL- YES. D10. RETURNED TO MANUFACTURER ON: 09-OCT-2025. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) WHEN USING PANEL PHOENIX NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 5196128. THE CUSTOMER RETURNED PHOENIX PRODUCTS, ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. TO INVESTIGATE, CUSTOMER RETURNED PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES ENTEROBACTER CLOACAE COMPLEX 337343312 AND KLEBSIELLA PNEUMONIAE 3771419 TO OBSERVE FOR ETP MIC RESULTS. NEXT, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES ENTEROBACTER CLOACAE COMPLEX 337343312 AND KLEBSIELLA PNEUMONIAE 3771419 TO OBSERVE FOR ETP MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH INTERMEDIATE OR RESISTANT ETP MIC RESULTS. FOR FURTHER INVESTIGATION, DISK DIFFUSION WAS PERFORMED ON CUSTOMER RETURNED ISOLATES ENTEROBACTER CLOACAE COMPLEX 337343312 AND KLEBSIELLA PNEUMONIAE 3771419. THE DISK DIFFUSION RESULTS SHOW BOTH ISOLATES WITH RESISTANCE TO ETP. AS ALL PANELS TESTED WERE EITHER INTERMEDIATE OR RESISTANT ETP MIC RESULTS, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. BD DOES NOT CONFIRM ON AN INTERMEDIATE (I) RESULT, AS IT IS ONE DILUTION OFF FROM SENSITIVE (S) OR RESISTANT (R). COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT ISOLATE HAD A HIGH MIC (FALSE RESISTANCE) FOR THE DRUG ERTAPENEM. THE USER CONFIRMED THE RESULT USING E-TEST STRIP. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT ISOLATE HAD A HIGH MIC (FALSE RESISTANCE) FOR THE DRUG ERTAPENEM. THE USER CONFIRMED THE RESULT USING E-TEST STRIP. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2125355 | BD PHOENIX¿ NMIC-306 | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 5196128 | 30382904492923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |