BD PHOENIX¿ PMIC/ID-106
Report
- Report Number
- 1119779-2024-00969
- Event Type
- Malfunction
- Date Received
- December 9, 2024
- Date of Event
- November 13, 2024
- Report Date
- January 21, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904486069
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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, K021954, K022172, K023273, K023301, K024152, K030677, K031306, K031679, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050555, K051689, K053241, K060214, K060217, K060218, K060218, K060493, K082538, K082852, K082913, AND K131331. 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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 18-NOV-2024. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS LUGDENENSIS WHEN USING PHOENIX PANEL PMIC/ID-106 (CATALOG NUMBER 448606) BATCH NUMBER 4254739. THE CUSTOMER RETURNED PANELS, ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW AN ISOLATE IDENTIFIED AS STAPHYLOCOCCUS CAPITIS WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED ISOLATE WAS VERIFIED AND LABELED AS S. LUGDENENSIS 11106808 WITH A BRUKER MALDI BIOTYPER. TO INVESTIGATE, CUSTOMER RETURNED PANELS WERE TESTED USING CUSTOMER RETURNED ISOLATE S. LUGDENENSIS 11106808 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, RETENTION PANELS FROM THE COMPLAINT BATCH AND CONTROL PANELS WERE TESTED USING CUSTOMER RETURNED ISOLATE S. LUGDENENSIS 11106808 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. SOME OF THE RETENTION AND CUSTOMER RETURNED PANELS TESTED WITH CUSTOMER RETURNED ISOLATE S. LUGDENENSIS 11106808 DID NOT CORRECTLY IDENTIFY THE ISOLATE AS S. LUGDENENSIS. ALL OTHER PANELS IDENTIFIED THE ISOLATE CORRECTLY AS S. LUGDENENSIS; THEREFORE, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION. 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. AS NO TREND HAS BEEN IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-106 A PATIENT ISOLATE (S. LUGDUNENSIS) WAS MISIDENTIFIED AS S. CAPITIS. THE USER NOTED THAT THE RESULTS FROM A MOLECULAR TESTING PLATFORM GAVE THE RESULT STAPH LUGDUNENSIS. REPEAT TESTING WAS PERFORMED WITH A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC/ID-106 A PATIENT ISOLATE (S. LUGDUNENSIS) WAS MISIDENTIFIED AS S. CAPITIS. THE USER NOTED THAT THE RESULTS FROM A MOLECULAR TESTING PLATFORM GAVE THE RESULT STAPH LUGDUNENSIS. REPEAT TESTING WAS PERFORMED WITH A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336701 | BD PHOENIX¿ PMIC/ID-106 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 4254739 | 30382904486069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |