BD PHOENIX PANEL NMIC-306
Report
- Report Number
- 1119779-2024-00543
- Event Type
- Malfunction
- Date Received
- July 7, 2024
- Date of Event
- June 2, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 00382904492922
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC MEROPENEM (MEM) AND ERTAPENEM (ETP) WITH CITROBACTER WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4100303. THE CUSTOMER DID NOT PROVIDE ISOLATES OR PANEL RETURNS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW HIGH MIC MEM AND ETP WITH CITROBACTER WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE CITROBACTER FREUNDII ENF 10852 THEN PLACED IN A PHOENIX M50 FOR MEM AND ETP MIC RESULTS. IN ADDITION, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE CITROBACTER FREUNDII ENF 10852 THEN PLACED IN A PHOENIX M50 FOR MEM AND ETP MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED ALL PANELS WITH THE EXPECTED MIC FOR MEM AND ETP. 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.
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 HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD PHOENIX PANEL NMIC-306, A SAMPLE GAVE DIFFERENT RESULTS WHEN RETESTED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE OF CITROBACTER CLOACAE COMPLEX THAT WAS TESTED 3 TIMES AND GIVING DIFFERENT RESULTS. THE FIRST AND SECOND TIMES ERTAPENEM WAS RESISTANT AND MEROPENEM SENSITIVE. THE RESULT OF THE THIRD TIME TESTING WAS NOT SPECIFIED. THE E-TEST WAS SUSCEPTIBLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE OF CITROBACTER CLOACAE COMPLEX THAT WAS TESTED 3 TIMES AND GIVING DIFFERENT RESULTS. THE FIRST AND SECOND TIMES ERTAPENEM WAS RESISTANT AND MEROPENEM SENSITIVE. THE RESULT OF THE THIRD TIME TESTING WAS NOT SPECIFIED. THE E-TEST WAS SUSCEPTIBLE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING BD PHOENIX PANEL NMIC-306, A SAMPLE GAVE DIFFERENT RESULTS WHEN RETESTED. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 894558 | BD PHOENIX PANEL NMIC-306 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 4100303 | 00382904492922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |