BD PHOENIX¿ NMIC-306
Report
- Report Number
- 1119779-2024-00972
- Event Type
- Malfunction
- Date Received
- December 10, 2024
- Date of Event
- November 18, 2024
- Report Date
- March 28, 2025
- 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
- CT, 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, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K181665, K173252, K190905, K163637, K173523, 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D1. MEDICAL DEVICE BRAND NAME: BD PHOENIX¿ NMIC-306. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) AND MEROPENEM (MEM) WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4268801. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND ISOLATES FOR THE INVESTIGATION. THE LAB REPORTS SHOW VARIED MIC RESULTS FOR CARBAPENEMS WITH PROTEUS MIRABILIS AND KLEBSIELLA PNEUMONIAE. IT IS TO BE NOTED THAT A CUSTOMER RETURNED ISOLATE DID NOT CORRESPOND WITH THE LAB REPORT PROVIDED. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE AND P. MIRABILIS AND PLACED IN A PHOENIX M50 TO EVALUATE FOR ETP AND MEM MIC RESULTS. NEXT, CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE AND P. MIRABILIS AND PLACED IN A PHOENIX M50 TO EVALUATE FOR ETP AND MEM MIC RESULTS. AT THE END OF THE RUN, ALL PANELS RETURNED THE EXPECTED ETP AND MEM MIC RESULTS. FURTHER INVESTIGATION WAS PERFORMED FOR THE CUSTOMER RETURNED P. MIRABILIS ISOLATE. DISC DIFFUSION TESTING SHOWS CUSTOMER RETURNED P. MIRABILIS WITH RESISTANCE TO ETP. 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. 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 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES IDENTIFIED AS PROTEUS MIRABILIS AND KLEBSIELLA PNEUMONIAE HAD HIGH MICS FOR THE DRUGS ERTAPENEM AND MEROPENEM. THE USER SENT THE ISOLATES TO THE STATE FOR CONFIRMATION OF RESULT, AS WELL AS PERFORMED AN E-TEST. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES IDENTIFIED AS PROTEUS MIRABILIS AND KLEBSIELLA PNEUMONIAE HAD HIGH MICS FOR THE DRUGS ERTAPENEM AND MEROPENEM. THE USER SENT THE ISOLATES TO THE STATE FOR CONFIRMATION OF RESULT, AS WELL AS PERFORMED AN E-TEST. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1634113 | BD PHOENIX¿ NMIC-306 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4268801 | 30382904492923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |