PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2023-01480
- Event Type
- Malfunction
- Date Received
- January 3, 2024
- Date of Event
- December 5, 2023
- Report Date
- February 20, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 00382904492892
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
BD PHOENIX NMIC/ID-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: G5. PMA / 510(K)#: K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320. 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 MISIDENTIFICATION OF PROTEUS MIRABILIS AS PROVIDENCIA RETTGERI WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3241425. THE CUSTOMER DID NOT RETURN ISOLATES OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW A PATIENT ISOLATE IDENTIFIED AS P. MIRABILIS AND P. RETTGERI ON THE COMPLAINT BATCH. TO INVESTIGATE, TWO RETENTION PANELS FROM COMPLAINT BATCH 3241425 WERE TESTED USING IN HOUSE ISOLATE P. MIRABILIS ENF 9912 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE P. MIRABILIS ENF 9912 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL FOUR PANELS TESTED IDENTIFIED THE ISOLATE AS P. MIRABILIS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. R&D PERFORMED AN ANALYSIS OF THE BINARY FILES AND DETERMINED THAT THE ID MADE BY THE PHOENIX IS AS EXPECTED BY THE RESULTS OF THE SUBSTRATES. 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. WHILE THERE HAS BEEN AN OBSERVATION OF A PERFORMANCE FAILURE BY THE CUSTOMER, BD HAS NOT BEEN ABLE TO REPLICATE THE FAILURE THROUGH INVESTIGATIVE TESTING. AN OVERALL REVIEW OF GRAM-NEGATIVE PERFORMANCE IS ON-GOING AND WILL CONTINUE TO BE INVESTIGATED. 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.
IT WAS REPORTED WHEN USING THE PANEL PHOENIX NMIC/ID-307 A MISIDENTIFICATION WAS REPORTED. A PATIENT ISOLATE WAS IDENTIFIED AS PROVIDENCIA RETTGERI ON ITS INITIAL TESTING, IT WAS THEN IDENTIFIED AS PROTEUS MIRABILIS WHEN RETESTED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHEN USING THE PANEL PHOENIX NMIC/ID-307 A MISIDENTIFICATION WAS REPORTED. A PATIENT ISOLATE WAS IDENTIFIED AS PROVIDENCIA RETTGERI ON ITS INITIAL TESTING, IT WAS THEN IDENTIFIED AS PROTEUS MIRABILIS WHEN RETESTED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436224 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 3241425 | 00382904492892 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |