BD PANEL PHOENIX NMIC-311
Report
- Report Number
- 1119779-2024-00067
- Event Type
- Malfunction
- Date Received
- February 2, 2024
- Date of Event
- January 9, 2024
- Report Date
- June 12, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 00382904494520
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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: 11-JAN-2024. INVESTIGATION SUMMARY : THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) AND CEFTAZIDIME (CAZ) WITH ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 3241572. THE CUSTOMER PROVIDED PANEL RETURNS, ISOLATE RETURNS, BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW A RESISTANT RESULT FOR ETP AND CAZ WITH E. COLI WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, ONE CUSTOMER RETURNED PANEL EACH OF THE COMPLAINT BATCH WERE INOCULATED WITH EACH CUSTOMER RETURNED ISOLATE E. COLI # 15, E. COLI # 46 AND E. COLI #84 AND PLACED IN A PHOENIX M50 FOR ETP AND CAZ MIC RESULTS. IN ADDITION, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI # 15, E. COLI # 46 AND E. COLI #84 AND PLACED IN A PHOENIX M50 FOR ETP AND CAZ MIC RESULTS. RESULTS OF THE TEST SHOW ALL PANELS RETURNED THE EXPECTED RESULTS FOR ETP AND CAZ. 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. A REVIEW OF COMPLAINTS REVEALED ONE OTHER COMPLAINT ON THIS BATCH, RELATED TO THIS DEFECT AND UNCONFIRMED. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.
BD PHOENIX NMIC-311 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: G.5. PMA / 510(K)#: K032299, K061355, K061327, K031912, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K060447, K032567, K060257, K023634, K123404, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
REPORT 3 OF 4. IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311, DISCREPANT RESULTS OCCURRED DURING RUN 1 PROVIDING SENSITIVE CEFTAZIDIME AND ERTAPENEM ANTIBIOTIC RESULTS ON A PATIENT. THE CUSTOMER RE-TESTED AND RESISTANT CEFTAZIDIME AND ERTAPENEM ANTIBIOTIC RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
REPORT 3 OF 4. IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311, DISCREPANT RESULTS OCCURRED DURING RUN 1 PROVIDING SENSITIVE CEFTAZIDIME AND ERTAPENEM ANTIBIOTIC RESULTS ON A PATIENT. THE CUSTOMER RE-TESTED AND RESISTANT CEFTAZIDIME AND ERTAPENEM ANTIBIOTIC RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256098 | BD PANEL PHOENIX NMIC-311 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 3241572 | 00382904494520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |