PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2025-00151
- Event Type
- Malfunction
- Date Received
- March 3, 2025
- Date of Event
- January 11, 2025
- Report Date
- March 24, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)# K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, 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 WITH ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL- YES, D10. RETURNED TO MANUFACTURER ON: 11-MAR-2025, H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY - THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4254904. THE CUSTOMER RETURNED PANELS, ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF ACINETOBACTER BAUMANII (ACCESSION # 25W970110) MISIDENTIFIED AS COMAMONAS TESTOSTERONI, PROTEUS MIRABILIS (ACCESSION # 25H970198) MISIDENTIFIED AS MORGANELLA MORGANII, ESCHERICHIA COLI (ACCESSION # 25H306217) MISIDENTIFIED AS SHIGELLA BOYDII, PROTEUS MIRABILIS (ACCESSION # 25X970335) MISIDENTIFIED AS PROVIDENCIA RETGERI AND M. MORGANII, AND KLUYVERA ASCORBATA (ACCESSION # 25W907514) MISIDENTIFIED AS K. PNEUMONIAE WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED AND LABELED AS A. BAUMANII UPMC-42, ENTEROBACTER ROGGENKAMPII UPMC-43, E. COLI UPMC-44, P. MIRABILIS UPMC-46 AND K. ASCORBATA UPMC-47 WITH A BRUKER MALDI BIOTYPER. TO INVESTIGATE, CUSTOMER RETURNED PANELS OF THE COMPLAINT BATCH WERE TESTED WITH CUSTOMER RETURNED ISOLATES A. BAUMANII UPMC-42, E. ROGGENKAMPII UPMC-43, E. COLI UPMC-44 AND K. ASCORBATA UPMC-47 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES A. BAUMANII UPMC-42, E. ROGGENKAMPII UPMC-43, E. COLI UPMC-44, P. MIRABILIS UPMC-46 AND K. ASCORBATA UPMC-47 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES A. BAUMANII UPMC-42, ENTEROBACTER ROGGENKAMPII UPMC-43, E. COLI UPMC-44, P. MIRABILIS UPMC-46 AND K. ASCORBATA UPMC-47 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATE E. ROGGENKAMPII UPMC-43 IDENTIFIED THE ISOLATE AS ENTEROBACTER CLOACAE, IN WHICH E. ROGGENKAMPII IS A PART OF THE E. CLOACAE COMPLEX. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATES A. BAUMANII UPMC-42, E. COLI UPMC-44, P. MIRABILIS UPMC-46 AND K. ASCORBATA UPMC-47 IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY. 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.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (ACINETOBACTER BAUMANII) WAS MISIDENTIFIED AS COMAMONAS TESTOSTERONE. UPON REPEAT THE ISOLATE WAS IDENTIFIED AS ACINETOBACTER BAUMANII. CONFIRMATORY TESTING WAS PERFORMED WITH A REFERENCE LABORATORY GIVING THE RESULT AS ACINETOBACTER BAUMANII. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 5.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (ACINETOBACTER BAUMANII) WAS MISIDENTIFIED AS COMAMONAS TESTOSTERONE. UPON REPEAT THE ISOLATE WAS IDENTIFIED AS ACINETOBACTER BAUMANII. CONFIRMATORY TESTING WAS PERFORMED WITH A REFERENCE LABORATORY GIVING THE RESULT AS ACINETOBACTER BAUMANII. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1331090 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4254904 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |