BD PHOENIX¿ NMIC/ID-307
Report
- Report Number
- 1119779-2025-05010
- Event Type
- Malfunction
- Date Received
- September 29, 2025
- Date of Event
- August 31, 2025
- Report Date
- February 11, 2026
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR INCORRECT BREAKPOINTS WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 5161720. CUSTOMER RETURNED PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS WERE NOT AVAILABLE FOR THE INVESTIGATION. THE CUSTOMER NOTED INCORRECT SUBSTRATE REACTIONS FOR CEFTAZIDIME (CAZ), CEFTRIAXONE (CRO), ERTAPENEM (ETP), AND MEROPENEM (MEM) WITH KLEBSIELLA AEROGENES, KLEBSIELLA PNEUMONIAE, PROTEUS VULGARIS AND ESCHERICHIA COLI WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES K. AEROGENES C2002, K. PNEUMONIAE FR103, K. AEROGENES 10856, P. VULGARIS 11157, E. COLI 18027 AND P. VULGARIS 9913 TO OBSERVE FOR CAZ, CRO, ETP AND MEM MIC RESULTS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES K. AEROGENES C2002, K. PNEUMONIAE FR103, K. AEROGENES 10856, P. VULGARIS 11157, E. COLI 18027 AND P. VULGARIS 9913 TO OBSERVE FOR CAZ, CRO, ETP AND MEM MIC RESULTS. THE INVESTIGATION RETURNED ALL PANELS WITH SATISFACTORY CAZ, CRO, ETP AND MEM MIC RESULTS, THEREFORE THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. 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.
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA /510(K)#: G4. PMA / 510(K)# K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, K033458 AND K123266. 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 BD PHOENIX¿ NMIC/ID-307 FIVE (5) PATIENT ISOLATES NOTED AS KLEBSIELLA AEROGENES, KLEBSIELLA PNEUMONIAE, ESCHERICHIA COLI, AND PROTEUS VULGARIS HAD HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS CEFTAZIDIME, CEFTRIAXONE, ERTAPENEM, AND MEROPENEM BUT WHEN REPEATED THE RESULTS WERE SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 5.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 FIVE (5) PATIENT ISOLATES NOTED AS KLEBSIELLA AEROGENES, KLEBSIELLA PNEUMONIAE, ESCHERICHIA COLI, AND PROTEUS VULGARIS HAD HIGH MIC (FALSE RESISTANT) RESULTS FOR THE DRUGS CEFTAZIDIME, CEFTRIAXONE, ERTAPENEM, AND MEROPENEM BUT WHEN REPEATED THE RESULTS WERE SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1218204 | BD PHOENIX¿ NMIC/ID-307 | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 5161720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |