BD PHOENIX PANEL NMIC-306
Report
- Report Number
- 1119779-2024-00568
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- July 2, 2024
- Report Date
- March 25, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY THIS COMPLAINT IS FOR HIGH MIC MEROPENEM (MEM) AND CEFEPIME (FEP) WITH PSEUDOMONAS AERUGINOSA WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4121481. THE CUSTOMER DID NOT PROVIDE ISOLATES, OR PANEL RETURNS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. TO INVESTIGATE, THREE RETENTION PANELS EACH OF THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES P. AERUGINOSA ENF 10414 AND P. AERUGINOSA ENF 10991 THEN PLACED IN A PHOENIX M50 FOR MEM AND FEP MIC RESULTS. IN ADDITION, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES P. AERUGINOSA ENF 10414 AND P. AERUGINOSA ENF 10991 THEN PLACED IN A PHOENIX M50 FOR MEM AND FEP MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED ALL PANELS WITH THE EXPECTED MIC FOR MEM AND FEP. 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.
THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: 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, 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 WERE UPDATED DUE TO A CORRECTION: INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC MEROPENEM (MEM) AND CEFEPIME (FEP) WITH PSEUDOMONAS AERUGINOSA WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4121481. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS BUT PROVIDED ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. TO INVESTIGATE, THREE RETENTION PANELS EACH OF THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES P. AERUGINOSA ENF 10414 AND P. AERUGINOSA ENF 10991 THEN PLACED IN A PHOENIX M50 FOR MEM AND FEP MIC RESULTS. IN ADDITION, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES P. AERUGINOSA ENF 10414 AND P. AERUGINOSA ENF 10991 THEN PLACED IN A PHOENIX M50 FOR MEM AND FEP MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED ALL PANELS TESTED WITH THE IN-HOUSE ISOLATES WITH THE EXPECTED MIC FOR MEM AND FEP. NEXT, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH THE 14 CUSTOMER RETURNED ISOLATES THEN PLACED IN A PHOENIX M50 FOR MEM AND FEP MIC RESULTS. IN ADDITION, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES P. AERUGINOSA ENF 10414 AND P. AERUGINOSA ENF 10991 THEN PLACED IN A PHOENIX M50 FOR MEM AND FEP MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED THE RETENTION AND CONTROL PANELS TESTED WITH CUSTOMER RETURNED ISOLATES P. AERUGINOSA (B)(6) AND P. AERUGINOSA (B)(6) RETURNED INCORRECT MIC RESULTS FOR MEM. ALL OTHER PANELS RETURNED THE EXPECTED MIC FOR MEM AND FEP. THIS COMPLAINT IS CONFIRMED. R&D PERFORMED A BIOCHEMICAL ANALYSIS OF THE BD TESTING LAB REPORTS AS WELL AS A REVIEW OF BD TESTING BINARY FILES. REVIEW OF THE BINARY FILES DID SHOW SOME GROWTH VARIABILITY IN THE ANTIBIOTIC AND GROWTH WELLS FROM THOSE EXPECTED. CUSTOMER RETURNED ISOLATE (B)(6) RETURNED A RESISTANT MIC ON DISC DIFFUSION (15MM), HOWEVER, THE RESULTS WERE CLOSE TO INTERMEDIATE (16 MM). CUSTOMER ISOLATE (B)(6) ALSO APPEARED TO BE SLOW GROWING. THESE TWO FACTORS COULD HAVE CAUSED DIFFICULTY FOR THE PHOENIX TO RETURN CORRECT MIC RESULTS. CUSTOMER RETURNED ISOLATE (B)(6) SHOWED UNEXPECTED GROWTH ACTIVITY IN SOME MEM WELLS (THESE WELLS BEGAN REACTING TO THE AST INDICATOR EARLIER THAN EXPECTED), WHICH COULD BE EXPLAINED BY CONTAMINATION OR MIXED RESISTANCE WITHIN THE ISOLATE POPULATION. 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.
IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 THE RESULT FOR THE DRUGS MEROPENEM AND CEFEPIME WERE INCONSISTENCE WITH WHAT THE USER EXPECTED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 THE RESULT FOR THE DRUGS MEROPENEM AND CEFEPIME WERE INCONSISTENCE WITH WHAT THE USER EXPECTED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 THE RESULT FOR THE DRUGS MEROPENEM AND CEFEPIME WERE INCONSISTENCE WITH WHAT THE USER EXPECTED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1240046 | BD PHOENIX PANEL NMIC-306 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 4121481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |