BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
Report
- Report Number
- 1119779-2023-00837
- Event Type
- Malfunction
- Date Received
- August 4, 2023
- Date of Event
- April 21, 2023
- Report Date
- August 17, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 00382904436247
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC RESULTS WITH FOSFOMYCIN (FF) WHEN USING PHOENIX PANEL NMIC-502 (449025) BATCH NUMBER 2033980. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES BUT PROVIDED BINARY FILES FOR THE INVESTIGATION. THE COMPLAINT BATCH WAS UNAVAILABLE FOR TESTING DUE TO THE BATCH BEING EXPIRED AT THE TIME OF INVESTIGATION AND BEYOND OUR STABILITY TIMEFRAME. AS A RESULT, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 2033980. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.
G5. PMA/510K INFO: K020321, K040099, K131331. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM DISCREPANCY IN RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHOENIX M50 IS WORKING IN SPECIFICATION AND ISOLATES WERE TESTED AT THE HEIDELBERG LOCATION WITH THE SAME RESULTS, CONFIRMING WORKFLOW. WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? INITIALLY THE LAB HAD DOUBTS AS FOR THE CPO ISOLATES, FF WAS THE ONLY SUSCEPTIBLE RESULT, AND GIVEN THE FACT THAT IT IS CRITICAL TO REPORT THIS RESULT AND USE IT TO MAKE A CLINICAL DECISION, THEY REPEATED THE TEST RESULTS. OBTAINED RESULTS DID NOT CORRELATE WELL WITH THE FIRST ONES WHICH RAISED FURTHER DOUBTS. IS A CONFIRMATORY TEST ALWAYS PERFORMED? IF BY CONFIRMATORY TEST YOU MEAN ¿AGAR DILUTION¿ AS A REFERENCE METHOD ¿ THE ANSWER IS NO. THIS IS BECAUSE THIS METHOD IS QUITE LABOR-INTENSIVE AND TIME CONSUMING. HOWEVER, LAB PERFORMED ¿COMPARATOR¿ METHODS (MICRONAUT AND VITEK) WHICH SHOWED DIFFERENT AND MORE REPRODUCIBLE RESULT WHICH WAS THE CAUSE OF THE FINAL JOINT COMPLAINT AND DOUBT.
IT WAS REPORTED THAT BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM DISCREPANCY IN RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHOENIX M50 IS WORKING IN SPECIFICATION AND ISOLATES WERE TESTED AT THE HEIDELBERG LOCATION WITH THE SAME RESULTS, CONFIRMING WORKFLOW. WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? INITIALLY THE LAB HAD DOUBTS AS FOR THE CPO ISOLATES, FF WAS THE ONLY SUSCEPTIBLE RESULT, AND GIVEN THE FACT THAT IT IS CRITICAL TO REPORT THIS RESULT AND USE IT TO MAKE A CLINICAL DECISION, THEY REPEATED THE TEST RESULTS. OBTAINED RESULTS DID NOT CORRELATE WELL WITH THE FIRST ONES WHICH RAISED FURTHER DOUBTS. IS A CONFIRMATORY TEST ALWAYS PERFORMED? IF BY CONFIRMATORY TEST YOU MEAN ¿AGAR DILUTION¿ AS A REFERENCE METHOD ¿ THE ANSWER IS NO. THIS IS BECAUSE THIS METHOD IS QUITE LABOR-INTENSIVE AND TIME CONSUMING. HOWEVER, LAB PERFORMED ¿COMPARATOR¿ METHODS (MICRONAUT AND VITEK) WHICH SHOWED DIFFERENT AND MORE REPRODUCIBLE RESULT WHICH WAS THE CAUSE OF THE FINAL JOINT COMPLAINT AND DOUBT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2336830 | BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON, DICKINSON & CO. (SPARKS) | 00382904436247 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |