BD PHOENIX¿ NMIC-306
Report
- Report Number
- 1119779-2025-00040
- Event Type
- Malfunction
- Date Received
- February 6, 2025
- Date of Event
- December 18, 2024
- Report Date
- April 3, 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
- 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, 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.
INVESTIGATION SUMMARY - THIS COMPLAINT IS FOR HIGH MIC MEROPENEM (MEM) WITH PSEUDOMONAS AERUGINOSA, KLEBSIELLA AEROGENES, ESCHERICHIA COLI, PROTEUS MIRABILIS, KLEBSIELLA PNEUMONIAE AND SERRATIA MARCESCENS WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4289942. THE CUSTOMER DID NOT RETURN PANELS BUT RETURNED ISOLATES, PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE PHOENIX GENERATED LAB REPORTS SHOW HIGH MIC MEM WITH PSEUDOMONAS AERUGINOSA, KLEBSIELLA AEROGENES, ESCHERICHIA COLI, PROTEUS MIRABILIS, KLEBSIELLA PNEUMONIAE AND SERRATIA MARCESCENS WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES P. AERUGINOSA N804023712, K. AEROGENES N806007690, E. COLI N80815124, P. AERUGINOSA N80915110, E. COLI N81401833, P. MIRABILIS N81600821, E. COLI N818021141, K. PNEUMONIAE N80502111, S. MARCESCENS N807007492, K. PNEUMONIAE N81316418 AND P. AERUGINOSA N8191012315 ON A PHOENIX M50 MACHINE AND EVALUATED FOR MEM MIC RESULTS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES P. AERUGINOSA N804023712, K. AEROGENES N806007690, E. COLI N80815124, P. AERUGINOSA N80915110, E. COLI N81401833, P. MIRABILIS N81600821, E. COLI N818021141, K. PNEUMONIAE N80502111, S. MARCESCENS N807007492, K. PNEUMONIAE N81316418 AND P. AERUGINOSA N8191012315 ON A PHOENIX M50 MACHINE AND EVALUATED FOR MEM MIC RESULTS. ALL PANELS TESTED RETURNED THE EXPECTED SENSITIVE MICS FOR MEM, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. 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 HAD HIGH MICS FOR THE DRUG MEROPENEM. CONFIRMATORY TESTING WAS PERFORMED USING E-TEST STRIP. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD HIGH MICS FOR THE DRUG MEROPENEM. CONFIRMATORY TESTING WAS PERFORMED USING E-TEST STRIP. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631416 | BD PHOENIX¿ NMIC-306 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4289942 | 30382904492923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |