BD PHOENIX¿ NMIC-311
Report
- Report Number
- 1119779-2024-00892
- Event Type
- Malfunction
- Date Received
- November 15, 2024
- Date of Event
- September 1, 2024
- Report Date
- April 16, 2025
- 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
- OH, 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 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 K123404 K132674 K132909 K151320 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.
INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER: 449452) BATCH NUMBER: 4191762. THE CUSTOMER DID NOT RETURN PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. TO INVESTIGATE, THREE RETENTION PANELS EACH OF THE COMPLAINT BATCH AND TWO CONTROL PANELS EACH WERE INOCULATED WITH IN HOUSE ISOLATES KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE ENF 11000 AND SERRATIA MARCESCENS ENF 11427 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR ETP MIC RESULTS. AT THE END OF THE RUN, ALL PANELS RETURNED THE EXPECTED MIC RESULTS. 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) WHEN USING PHOENIX PANEL(B)(6) (CATALOG NUMBER 449452) BATCH NUMBER 4191762. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW SERRATIA MARCESCENS AND KLEBSIELLA PNEUMONIAE WITH VARIOUS MICS FOR ETP WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES SERRATIA MARCESCENS (ACCESSION # 198), KLEBSIELLA PNEUMONIAE (ACCESSION # 698) AND KLEBSIELLA PNEUMONIAE (ACCESSION # 321) AND PLACED IN A PHOENIX M50 TO EVALUATE FOR ETP MIC RESULTS. ALSO, THREE RETENTION PANELS EACH OF THE COMPLAINT BATCH AND TWO CONTROL PANELS EACH WERE INOCULATED WITH IN-HOUSE ISOLATES KLEBSIELLA PNEUMONIAE SSP PNEUMONIAE ENF (B)(4) AND SERRATIA MARCESCENS ENF (B)(4) AND PLACED IN A PHOENIX M50 TO EVALUATE FOR ETP MIC RESULTS. AT THE END OF THE RUN, ALL PANELS RETURNED THE EXPECTED MIC RESULTS FOR 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. AS NO TREND HAS BEEN 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-311 A PATIENT ULCER ISOLATE (SERRATIA MARCESCENS) HAD A HIGH MIC (FALSE RESISTANT) FOR THE DRUG ERTAPENEM. THE ISOLATE WAS RETESTED AND GAVE A SENSITIVE RESULT. IN ADDITION, OTHER CONFIRMATORY TESTING WAS PERFORMED, E.G. E TEST AND DISK DIFFUSION WHICH GAVE SENSITIVE RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 4.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT BLOOD ISOLATE (KLEBSIELLA PNEUMONIAE) HAD A HIGH MIC (FALSE RESISTANT) FOR THE DRUG ERTAPENEM. THE ISOLATE WAS RETESTED AND GAVE A SENSITIVE RESULT. IN ADDITION, OTHER CONFIRMATORY TESTING WAS PERFORMED, E.G. E TEST AND DISK DIFFUSION WHICH GAVE SENSITIVE RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 4.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 A PATIENT ULCER ISOLATE (SERRATIA MARCESCENS) HAD A HIGH MIC (FALSE RESISTANT) FOR THE DRUG ERTAPENEM. THE ISOLATE WAS RETESTED AND GAVE A SENSITIVE RESULT. IN ADDITION, OTHER CONFIRMATORY TESTING WAS PERFORMED, E.G. E TEST AND DISK DIFFUSION WHICH GAVE SENSITIVE RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56351 | BD PHOENIX¿ NMIC-311 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4191762 | 30382904494521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |