PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2024-00808
- Event Type
- Malfunction
- Date Received
- November 5, 2024
- Date of Event
- October 5, 2024
- Report Date
- March 18, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- K181665
- 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 A CLARIFICATION: INVESTIGATION SUMMARY THIS COMPLAINT IS FOR MISIDENTIFICATION OF PROTEUS MIRABILIS AND ENTEROBACTER CLOACAE/COMPLEX WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4191751. THE CUSTOMER PROVIDED ISOLATES, PANEL RETURNS, BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE PHOENIX GENERATED LAB REPORT SHOWS AN ISOLATE IDENTIFIED AS ENTEROBACTER CLOACAE WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED WITH THE CUSTOMER PROVIDED ACCESSION NUMBERS: (B)(6). IT IS TO BE NOTED THAT ISOLATE #(B)(6) WAS FOUND TO BE MIXED UPON SUBCULTURING, MALDI WAS RUN ON THE ROUND (ISOLATE 4A) AND SPREAD (ISOLATE 4B) COLONIES AND THEY WERE FOUND TO BE ENTEROBACTER HORMAECHEI, WHICH IS A MEMBER OF THE E. CLOACAE COMPLEX. TO INVESTIGATE, ONE CUSTOMER RETURNED PANEL EACH FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES (B)(6) ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ADDITIONALLY, TWO RETENTION PANELS EACH OF THE COMPLAINT BATCH AND TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES (B)(6) ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL CUSTOMER RETURNED ORGANISMS RETURNED THE CORRECT IDENTIFICATION RESULTS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. 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. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.
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 WITH ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 11-OCT-2024. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF PROTEUS MIRABILIS AND ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4191751. THE CUSTOMER PROVIDED ISOLATES, PANEL RETURNS, BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE PHOENIX GENERATED LAB REPORT SHOWS AN ISOLATE IDENTIFIED AS ENTEROBACTER CLOACAE WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED ISOLATE WAS VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS P. MIRABILIS 24W964870, E. HORMAECHEI 24M64687, E. HORMAECHEI 24M64697-4A AND E. HORMAECHEI 24M64697-4B. IT IS TO BE NOTED THAT ISOLATE 24M964697 WAS FOUND TO BE MIXED UPON SUBCULTURING, MALDI WAS RUN ON THE ROUND (ISOLATE 4A) AND SPREAD (ISOLATE 4B) COLONIES AND THEY WERE FOUND TO BE ENTEROBACTER HORMAECHEI, WHICH IS A MEMBER OF THE E. CLOACAE COMPLEX. TO INVESTIGATE, ONE CUSTOMER RETURNED PANEL EACH FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES P. MIRABILIS 24W964870, E. HORMAECHEI 24M64687, E. HORMAECHEI 24M64697-4A AND E. HORMAECHEI 24M64697-4B ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ADDITIONALLY, TWO RETENTION PANELS EACH OF THE COMPLAINT BATCH AND TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES P. MIRABILIS 24W964870, E. HORMAECHEI 24M64687, E. HORMAECHEI 24M64697-4A AND E. HORMAECHEI 24M64697-4B ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE CONTROL PANELS TESTED WITH CUSTOMER RETURNED ISOLATE E. HORMAECHEI 24M64697-4B IDENTIFIED THE ISOLATE AS CITROBACTER FARMERI. ALL OTHER PANELS TESTED WITH E. HORMAECHEI E. HORMAECHEI 24M64687, E. HORMAECHEI 24M64697-4A AND E. HORMAECHEI 24M64697-4B RETURNED E. CLOACAE IDENTIFICATION RESULTS, WHICH IS A MEMBER OF THE E. CLOACAE COMPLEX. THE PHOENIX PANELS TESTED WITH P. MIRABILIS 24W964870 RETURNED P. MIRABILIS IDENTIFICATION RESULTS. FOR FURTHER INVESTIGATION, ONE CUSTOMER RETURNED PANEL FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE E. HORMAECHEI 24M64697-4B ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THEN, TWO RETENTION PANELS OF THE COMPLAINT BATCH AND TWO CONTROL PANELS WERE TESTED USING CUSTOMER RETURNED ISOLATE E. HORMAECHEI 24M64697-4B ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS RETURNED E. CLOACAE IDENTIFICATION RESULTS; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. 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. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE WAS IDENTIFIED AS (B)(6), BUT UPON REPEAT THE ISOLATE WAS IDENTIFIED AS PROTEUS MIRABILIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 3 OF 3.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE WAS IDENTIFIED AS MORGANELLA MORGANII, BUT UPON REPEAT THE ISOLATE WAS IDENTIFIED AS PROTEUS MIRABILIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 3 OF 3.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE WAS IDENTIFIED AS MORGANELLA MORGANII, BUT UPON REPEAT THE ISOLATE WAS IDENTIFIED AS PROTEUS MIRABILIS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 3 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1405220 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4191751 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |