PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2023-01338
- Event Type
- Malfunction
- Date Received
- December 12, 2023
- Date of Event
- November 20, 2023
- Report Date
- March 20, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- K181665
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MULTIPLE MISIDENTIFICATIONS WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3213134. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS, ELEVEN ISOLATES AND BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW PATIENT ISOLATE MISIDENTIFICATIONS OF ESCHERICHIA COLI AS ENTEROBACTER CLOACAE OR CITROBACTER FARMERI, AS WELL AS PROTEUS MIRABILIS MISIDENTIFIED AS E. CLOACAE OR CITROBACTER BRAKII WHILE USING THE COMPLAINT BATCH 3213134. THE ELEVEN CUSTOMER RETURNED ISOLATES WERE LABELED AND VERIFIED AS EITHER E. COLI, OR P. MIRABILIS ON A BRUKER MALDI BIOTYPER. TO INVESTIGATE, ONE RETENTION PANEL EACH FROM COMPLAINT BATCH 3213134 WERE TESTED USING EACH CUSTOMER RETURNED E. COLI ISOLATE FOR A TOTAL OF TWELVE PANELS TESTED ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, ONE RETENTION PANEL EACH FROM COMPLAINT BATCH 3213134 WERE TESTED USING EACH CUSTOMER RETURNED P. MIRABILIS ISOLATE FOR A TOTAL OF TWO PANELS TESTED ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THEN, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING EACH CUSTOMER RETURNED E. COLI ISOLATE ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS FOR A TOTAL OF 24 PANELS TESTED WITH E. COLI ON CONTROL PANELS. LAST, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING EACH CUSTOMER RETURNED P. MIRABILIS ISOLATE ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS FOR A TOTAL OF 4 PANELS TESTED WITH P. MIRABILIS ON CONTROL PANELS. ALL RETENTION AND CONTROL PANELS INOCULATED WITH THE CUSTOMER RETURNED E. COLI ISOLATES RETURNED THE CORRECT IDENTIFICATION. THE RETENTION AND CONTROL PANELS INOCULATED WITH CUSTOMER RETURNED ISOLATE P. MIRABILIS (M-10) RETURNED THE CORRECT IDENTIFICATION. THE RETENTION AND CONTROL PANELS INOCULATED WITH CUSTOMER RETURNED ISOLATE P. MIRABILIS (M-6) RETURNED INCORRECT ID (P. RETTGERI AND MORGANELLA MORGANII). AS SOME OF THE PANELS TESTED WITH CUSTOMER ISOLATE P. MIRABILIS (M-6) RETURNED THE INCORRECT ID OR NO ID, FURTHER TESTING WAS PERFORMED. TO INVESTIGATE, ONE PANEL FROM THE COMPLAINT BATCH AND ONE CONTROL PANEL WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE P. MIRABILIS M-6 AND PLACED IN A PHOENIX M50 FOR IDENTIFICATION RESULTS. ALSO, TWO PANELS FROM THE COMPLAINT BATCH AND ONE CONTROL PANEL WERE INOCULATED WITH IN HOUSE ISOLATE P. MIRABILIS ENF9912 AND PLACED IN A PHOENIX M50 FOR IDENTIFICATION RESULTS. ALL FIVE PANELS IDENTIFIED THE ISOLATE AS P. MIRABILIS. BASED ON THE RESULTS OF THE INTERNAL INVESTIGATION, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION OF P. MIRABILIS BUT NOT CONFIRMED FOR MISIDENTIFICATION OF E.COLI. A REVIEW OF THE E. COLI BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. FOR FURTHER REVIEW, R&D PERFORMED AN ANALYSIS/COMPARISON BETWEEN THE BD TESTING LAB REPORTS AND THE CUSTOMER LAB REPORTS AS WELL AS THE CUSTOMER PROVIDED BINARY FILES. THE CUSTOMER SUBMITTED BINARY FILES CONFIRMED VARIABILITY IN SUBSTRATE REACTIONS FROM THOSE EXPECTED FOR PROTEUS MIRABILIS. REVIEW OF THE LAB REPORTS FROM BD¿S INTERNAL TESTING SHOWS VARIABILITY IN ONE OF THE SUBSTRATE REACTIONS. THE IDS BETWEEN PROVIDENCIA RETTGERI AND PROTEUS MIRABILIS ARE VERY CLOSELY RELATED. BASED ON THE ANALYSIS, THERE WERE NO RESULTS THAT STOOD OUT TO BE A DEFINITIVE CAUSE OF THE P. MIRABILIS MIS IDS. AN OVERALL REVIEW OF GRAM-NEGATIVE PERFORMANCE IS ON-GOING AND WILL CONTINUE TO BE INVESTIGATED. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON COMPLAINT BATCH 3213134, RELATED TO THIS DEFECT AND UNCONFIRMED. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT.
IT WAS REPORTED WHEN USING THE PANEL PHOENIX NMIC/ID-307, A PATIENT ISOLATE PROTEUS MIRABILIS WAS MISIDENTIFIED BY PHOENIX M50 AS CITROBACTER BRAAKII. ADDITIONAL TESTING WAS PERFORMED TO CONFIRM THE PATIENT RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 11.
IT WAS REPORTED WHEN USING THE PANEL PHOENIX NMIC/ID-307, A PATIENT ISOLATE PROTEUS MIRABILIS WAS MISIDENTIFIED BY PHOENIX M50 AS CITROBACTER BRAAKII. ADDITIONAL TESTING WAS PERFORMED TO CONFIRM THE PATIENT RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 11.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1580756 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 3213134 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |