BD PHOENIX¿ PMIC-108
Report
- Report Number
- 1119779-2024-00565
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- June 20, 2024
- Report Date
- October 25, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904484188
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G5. PMA / 510(K)#: K020322, K021954, K022172, K023273, K023301, K024152, K030677, K031306, K031589, K031679, K032131, K033784, K033907, K040006, K040106, K040716, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, AND K131331. 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 HIGH MIC VANCOMYCIN (VA) WITH STAPHYLOCOCCUS AUREUS WHEN USING PHOENIX PANEL PMIC-108 (CATALOG NUMBER 448418) BATCH NUMBER 3332901. THE CUSTOMER DID NOT PROVIDE ISOLATES, PANEL RETURNS OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. TO INVESTIGATE, THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE S. AUREUS 7146 THEN PLACED IN A PHOENIX M50 FOR VA MIC RESULTS. IN ADDITION, ONE CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE S. AUREUS 7146 THEN PLACED IN A PHOENIX M50 FOR VA MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED ALL PANELS WITH THE EXPECTED MIC FOR VA. THIS COMPLAINT IS NOT CONFIRMED. 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 WHILE USING THE BD PHOENIX¿ PMIC-108 AN UNSPECIFIED NUMBER OF PATIENT SAMPLES HAVE A HIGH MIC FOR THE DRUG VANCOMYCIN FOR THE ISOLATE STAPHYLOCOCCUS AUREUS. ONE ERRONEOUS PATIENT RESULT WAS REPORTED. THERE WAS NO PATIENT TREATMENT CHANGE AS A RESULT. CONFIRMATORY TESTING PERFORMED ON THE MICROSCAN, WHERE THE ISOLATE WAS NOT RESISTANT.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PMIC-108 AN UNSPECIFIED NUMBER OF PATIENT SAMPLES HAVE A HIGH MIC FOR THE DRUG VANCOMYCIN FOR THE ISOLATE STAPHYLOCOCCUS AUREUS. ONE ERRONEOUS PATIENT RESULT WAS REPORTED. THERE WAS NO PATIENT TREATMENT CHANGE AS A RESULT. CONFIRMATORY TESTING PERFORMED ON THE MICROSCAN, WHERE THE ISOLATE WAS NOT RESISTANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 354405 | BD PHOENIX¿ PMIC-108 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 3332901 | 30382904484188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |