BD PHOENIX PANEL NMIC-306
Report
- Report Number
- 1119779-2024-00001
- Event Type
- Malfunction
- Date Received
- January 3, 2024
- Date of Event
- November 10, 2023
- Report Date
- June 10, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 00382904492922
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
E1: (B)(6). BD PHOENIX NMIC-306 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: G5. 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, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K163637, K173252, K173523, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K190905. 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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 09-JAN-2024. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MIC DISCREPANCIES OF CEFEPIME (FEP) WITH PSEUDOMONAS AERUGINOSA WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 3192641. THE CUSTOMER PROVIDED PANEL RETURNS, ISOLATE RETURNS, BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB RESULTS SHOW RESISTANT AND SENSITIVE MIC RESULTS WITH P. AERUGINOSA WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES P. AERUGINOSA W157983 AND P. AERUGINOSA M25802 AND PLACED IN A PHOENIX M50 FOR FEP MIC RESULTS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES P. AERUGINOSA W157983 AND P. AERUGINOSA M25802 AND PLACED IN A PHOENIX M50 FOR FEP MIC RESULTS. LAST, ONE CUSTOMER RETURNED PANEL WAS INOCULATED WITH CUSTOMER RETURNED ISOLATE P. AERUGINOSA M25802 AND PLACED IN A PHOENIX M50 FOR FEP MIC RESULTS. DISC DIFFUSION WAS PERFORMED ON THE CUSTOMER RETURNED ISOLATES TO VERIFY FEP SUSCEPTIBILITY. RESULTS OF THE INVESTIGATION SHOW THE EXPECTED MIC RESULTS FOR FEP WHEN USING THE COMPLAINT BATCH WITH P. AERUGINOSA. THIS COMPLAINT IS NOT CONFIRMED. THE BREAKPOINTS PUBLISHED IN CLSI M100, 33RD ED /M45-A3 REMAIN UNCHANGED IN THE BD PHOENIX¿, BD EPICENTER¿, AND BD SYNAPSYS¿ SYSTEMS. THE PUD BREAKPOINTS LISTED IN THIS TABLE ARE NOT ALIGNED WITH THE CURRENT CLSI M100 BREAKPOINTS EITHER DUE TO THESE BREAKPOINTS NOT BEING RECOGNIZED BY THE FDA SUSCEPTIBILITY TESTING INTERPRETIVE CRITERIA (STIC) WEBSITE OR PERFORMANCE WITH THE UPDATED BREAKPOINTS HAS NOT YET BEEN EVALUATED INTERNALLY BY BD FOR THE BD PHOENIX ¿ SYSTEM. AS BD PHOENIX¿ CURRENTLY HAS ONLY ONE CLSI INTERPRETATIONAL RULE SET, THIS BREAKPOINT SET IS INFLUENCED BY THE FDA FOR US CUSTOMERS. 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 WHEN USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE HAD A DISCREPANT RESULT FOR THE DRUG CEFEPIME WHEN COMPARED TO THE KIRBY BAUER (KB) DISK RESULT. THE PANEL RESULT WAS RESISTANT WHILE THE KB WAS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 3.
IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE HAD A DISCREPANT RESULT FOR THE DRUG CEFEPIME WHEN COMPARED TO THE KIRBY BAUER (KB) DISK RESULT. THE PANEL RESULT WAS RESISTANT WHILE THE KB WAS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436226 | BD PHOENIX PANEL NMIC-306 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 3192641 | 00382904492922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |