PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2025-00020
- Event Type
- Malfunction
- Date Received
- January 31, 2025
- Date of Event
- December 6, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- K181665
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL- YES D10. RETURNED TO MANUFACTURER ON: 16-JAN-2025 H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY - THIS COMPLAINT IS FOR MISIDENTIFICATION OF SERRATIA MARCESCENS AS SERRATIA FONTICOLA AND ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4233325. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND AN ISOLATE FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF SERRATIA FONTICOLA AND ESCHERICHIA COLI WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, EIGHT RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS UPMC-29 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCHES WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS UPMC-29 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. FOUR OF THE EIGHT RETENTION PANELS TESTED RETURNED S. FONTICOLA IDENTIFICATION RESULTS, TWO OF THE CONTROL PANELS TESTED RETURNED E. COLI RESULTS. ALL OTHER PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES AS S. MARCESCENS, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION OF S. MARCESCENS UPMC-29. 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE OF SERRATIA MARCESCENS WAS MISIDENTIFIED. THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE (SERRATIA MARCESCENS) WAS MISIDENTIFIED AS SERRATIA FONTICOLA. REPEAT TESTING WAS PERFORMED GIVING THE RESULT E. COLI. THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE (SERRATIA MARCESCENS) WAS MISIDENTIFIED AS SERRATIA FONTICOLA. REPEAT TESTING WAS PERFORMED GIVING THE RESULT E. COLI. THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT.
IT WAS REPORTED WHILE USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE OF SERRATIA MARCESCENS WAS MISIDENTIFIED. THE ISOLATE WAS TESTED WITH A REFERENCE LABORATORY TO CONFIRM THE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 519398 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4233325 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |