BD PHOENIX¿ PMIC/ID-107
Report
- Report Number
- 1119779-2023-01406
- Event Type
- Malfunction
- Date Received
- December 22, 2023
- Date of Event
- October 26, 2023
- Report Date
- February 27, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 00382904486075
- 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
G.5. PMA / 510(K)#: THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED: K020322, K021954, K023273, K023301, K024152, K030677, K031306, K031679, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, 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.
H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STAPHYLOCOCCUS SIMULANS AS STAPHYLOCOCCUS HAEMOLYTICUS WHEN USING PHOENIX PANEL PMIC/ID-107 (CATALOG NUMBER 448607) BATCH NUMBER 3150503. 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 S. HAEMOLYTICUS ON THE COMPLAINT BATCH. TO INVESTIGATE, FIVE RETENTION PANELS FROM COMPLAINT BATCH 3150503 WERE TESTED USING IN HOUSE ISOLATE S. SIMULANS POS 1830 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 S. SIMULANS POS 1830 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. TWO OF THE FIVE PANELS FROM THE COMPLAINT BATCH IDENTIFIED THE ISOLATE AS S. EPIDERMIDIS, WHILE ALL THE OTHER PANELS IDENTIFIED THE ISOLATE AS S. SIMULANS, THEREFORE, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION. AS PART OF THE INVESTIGATION, BD R&D PERFORMED AN ANALYSIS/COMPARISON BETWEEN THE BD TESTING LAB REPORTS AND THE CUSTOMER LAB REPORTS. THE IDS BETWEEN S. SIMULANS AND S. HAEMOLYTICUS ARE VERY CLOSELY RELATED. BASED ON THE ANALYSIS, THERE WERE NO RESULTS IN THE CHEMICAL REACTIONS THAT STOOD OUT TO BE A DEFINITIVE CAUSE OF THE S. SIMULANS MIS IDS. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. 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.
IT WAS REPORTED WHEN USING THE BD PHOENIX¿ PMIC/ID-107 A MISIDENTIFICATION WAS REPORTED. THE PATIENT'S ISOLATE ((B)(6)) WAS MISIDENTIFIED AS S. HAEMOLYTICUS. THE RESULT WAS CONFIRMED BY THE REFERENCE LABORATORY AND IDENTIFIED AS S. SIMULANS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHEN USING THE BD PHOENIX¿ PMIC/ID-107 A MISIDENTIFICATION WAS REPORTED. THE PATIENT'S ISOLATE ((B)(6)) WAS MISIDENTIFIED AS S. HAEMOLYTICUS. THE RESULT WAS CONFIRMED BY THE REFERENCE LABORATORY AND IDENTIFIED AS S. SIMULANS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2288377 | BD PHOENIX¿ PMIC/ID-107 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON DICKINSON & CO. (SPARKS) | 3150503 | 00382904486075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |