PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2024-01010
- Event Type
- Malfunction
- Date Received
- December 18, 2024
- Date of Event
- December 1, 2024
- Report Date
- March 20, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- 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 HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL- YES. D10. RETURNED TO MANUFACTURER ON: 12-DEC-2024. 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 4233325. THE CUSTOMER RETURNED PANELS, ISOLATES, PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW MISIDENTIFICATIONS OF ACINETOBACTER BAUMANNII AS CEDECEA LAPAGEI, ENTEROBACTER CLOACAE AS KLUYVERA INTERMEDIA, KLEBSIELLA PNEUMONIAE AS ENTEROBACTER CLOACAE, SERRATIA MARCESCENS AS CEDECEA DAVISAE, ENTEROBACTER CLOACAE AS CITROBACTER FREUNDII, ESCHERICHIA COLI AS SHIGELLA DYSENTERIAE, PROTEUS MIRABILIS AS PROVIDENCIA RETTGERI AND KLEBSIELLA PNEUMONIAE AS ENTEROBACTER CLOACAE WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS A. BAUMANNII UPMC-18, E. HORMAECHEI UPMC-21, K. PNEUMONIAE UPMC-22, S. MARCESCENS UPMC-23, E. HORMAECHEI UPMC-25, E. COLI UPMC-26, P. MIRABILIS UPMC-27 AND E. HORMAECHEI UPMC-28. TO INVESTIGATE, CUSTOMER RETURNED PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES A. BAUMANNII UPMC-18, E. HORMAECHEI UPMC-21, K. PNEUMONIAE UPMC-22 AND S. MARCESCENS UPMC-23 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS NEXT, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES A. BAUMANNII UPMC-18, E. HORMAECHEI UPMC-21, K. PNEUMONIAE UPMC-22, S. MARCESCENS UPMC-23, E. HORMAECHEI UPMC-25, E. COLI UPMC-26, P. MIRABILIS UPMC-27 AND E. HORMAECHEI UPMC-28 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES S. MARCESCENS UPMC-23, E. HORMAECHEI UPMC-25, E. COLI UPMC-26 AND P. MIRABILIS UPMC-27 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATES A. BAUMANNII UPMC-18, E. HORMAECHEI UPMC-21, K. PNEUMONIAE UPMC-22, E. HORMAECHEI UPMC-25, P. MIRABILIS UPMC-27 AND E. HORMAECHEI UPMC-28 IDENTIFIED THEIR RESPECTIVE ISOLATES CORRECTLY. ALL PANELS TESTED WITH CUSTOMER RETURNED ISOLATES S. MARCESCENS UPMC-23, E. COLI UPMC-26 AND E. HORMAECHEI UPMC-28 RETURNED MISIDENTIFICATION RESULTS, THEREFORE, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION. AS PART OF THE INVESTIGATION, BD R&D PERFORMED AN ANALYSIS OF THE CUSTOMER BINARY FILES. REVIEW OF THE BINARY FILES FROM THE CUSTOMER'S INTERNAL TESTING SHOWS VARIABILITY IN SOME OF THE SUBSTRATE REACTIONS. REVIEW OF THE FILES SHOWS THAT SOME OF THE SUBSTRATE REACTIONS WERE MORE ALIGNED WITH A SHIGELLA DYSENTERIAE IDENTIFICATION AS OPPOSED TO ESCHERICHIA COLI. 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.
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS SHIGELLA DYSENTERIAE. REPEAT TESTING WAS PERFORMED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 6 OF 8.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS SHIGELLA DYSENTERIAE. REPEAT TESTING WAS PERFORMED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 6 OF 8.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2115622 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4233325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |