BD PHOENIX PANEL NMIC-306
Report
- Report Number
- 1119779-2023-01349
- Event Type
- Malfunction
- Date Received
- December 12, 2023
- Date of Event
- November 21, 2023
- Report Date
- May 28, 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
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION; B5: DESCRIBE EVENT, " IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 PATIENT ISOLATE OF K. KOSERI WAS REPORTED AS FALSE POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). "
H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE POSITIVE CARBAPENEM RESISTANT ENTEROBACTERIAECEAE (CRE) RESULTS WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH 3192114. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS BUT PROVIDED ISOLATE RETURNS AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW POSITIVE CRE RESULTS FOR KLEBSIELLA PNEUMONIAE, ESCHERICHIA COLI, AND CITROBACTER KOSERI WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED TWO K. PNEUMONIAE ISOLATES AND ONE E. COLI ISOLATE. TO INVESTIGATE, TWO RETENTION PANELS EACH FROM COMPLAINT BATCH 3192114 WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE #1, K. PNEUMONIAE #2, AND E. COLI TO OBSERVE FOR CRE RESULTS. IN ADDITION, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT A DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE #1, K. PNEUMONIAE #2, AND E. COLI TO OBSERVE FOR CRE RESULTS. THE INVESTIGATION RETURNED ALL NINE PANELS CLASSIFYING AS CRE NEGATIVE; THEREFORE 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. A REVIEW OF COMPLAINTS REVEALED NO OTHER COMPLAINTS ON THIS BATCH. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.
IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 PATIENT ISOLATE OF E. COLI WAS REPORTED AS FALSE POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). REPORT 3 OF 5.
IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 PATIENT ISOLATE OF K. KOSERI WAS REPORTED AS FALSE POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). REPORT 3 OF 5.
IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 PATIENT ISOLATE OF E. COLI WAS REPORTED AS FALSE POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). REPORT 3 OF 5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1289210 | BD PHOENIX PANEL NMIC-306 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | UNKNOWN | 00382904492922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |