PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2024-01077
- Event Type
- Malfunction
- Date Received
- January 21, 2025
- Date of Event
- December 21, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- SEE H11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
E1. INITIAL REPORTER PHONE #: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020321, K040099, 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 MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA BOYDII AND SHIGELLA DYSENTERIAE WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 4121483. THE CUSTOMER DID NOT RETURN PANELS BUT PROVIDED ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF S. BOYDII AND S. DYSENTERIAE WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES E. COLI CV-1 AND E. COLI CV-2 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING QC ISOLATE E. COLI A25922 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, CONTROL PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES E. COLI CV-1 AND E. COLI CV-2 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED WITH CUSTOMER RETURNED AND QC ISOLATES E. COLI CV-2 AND E. COLI A25922 RETURNED E. COLI IDENTIFICATION RESULTS. THE PANELS TESTED WITH CUSTOMER RETURNED ISOLATE E. COLI CV-1 IDENTIFIED THE ISOLATE AS SHIGELLA BOYDII. THIS COMPLAINT IS CONFIRMED. THE DIFFICULTY IN DIFFERENTIATING BETWEEN SHIGELLA SPECIES AND ESCHERICHIA COLI, BOTH CLOSELY RELATED MEMBERS OF THE ENTEROBACTERALES GROUP, IS WIDELY KNOWN. ALTHOUGH THESE SPECIES ARE PHENOTYPICALLY VERY SIMILAR, THEY ARE EPIDEMIOLOGICALLY DIFFERENT IN THEIR PRESENTATION OF CLINICAL DISEASE. BECAUSE OF THIS, MANY CLINICAL LABORATORIES WILL INCORPORATE GUIDANCE IN THEIR STANDARD OPERATING PROCEDURES FOR RULING OUT MISIDENTIFICATION OF SHIGELLA SPECIES AND E. COLI BY COMMON IDENTIFICATION SYSTEMS BY CHECKING COLONY MORPHOLOGY AND INDOLE AND MOTILITY REACTIONS. IF, AFTER ASSESSMENT OF ALL AVAILABLE INFORMATION, A CLINICAL LAB IS UNABLE TO CONFIDENTLY REPORT AN IDENTIFICATION BETWEEN THESE TWO SPECIES, THE ISOLATE MAY BE SENT TO A REFERENCE LABORATORY FOR DEFINITIVE IDENTIFICATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO CURRENT TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. 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 WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B3. DATE OF EVENT: 21-DEC-2024 B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (E. COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII THEN SHIGELLA DYSENTERIAE UPON REPEAT. THE ISOLATE WAS VERIFIED USING A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. B6. RELEVANT TESTS/LABORATORY DATA: REPEAT TESTING D4. MEDICAL DEVICE BRAND NAME: BD PHOENIX¿ NMIC/ID-307 MEDICAL DEVICE CATALOG #: 449289 MEDICAL DEVICE EXPIRATION DATE: 27-APR-2025 MEDICAL DEVICE LOT #: 4121483 UNIQUE IDENTIFIER (UDI) #: (B)(4). G4. PMA / 510(K)# K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320, K181665, K033458 AND K123266 H4. DEVICE MANUFACTURE DATE: 30-APR-2024. H5. LABELED FOR SINGLE USE: YES.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (E. COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII THEN SHIGELLA DYSENTERIAE UPON REPEAT. THE ISOLATE WAS VERIFIED USING A REFERENCE LABORATORY. 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 BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM A PATIENT ISOLATE (E. COLI) WAS MISIDENTIFIED AS SHIGELLA DYSENTERIAE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (E. COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII THEN SHIGELLA DYSENTERIAE UPON REPEAT. THE ISOLATE WAS VERIFIED USING A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (E. COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII THEN SHIGELLA DYSENTERIAE UPON REPEAT. THE ISOLATE WAS VERIFIED USING A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC/ID-307 A PATIENT ISOLATE (E. COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII THEN SHIGELLA DYSENTERIAE UPON REPEAT. THE ISOLATE WAS VERIFIED USING A REFERENCE LABORATORY. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 859776 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON DICKINSON & CO. (SPARKS) | 4121483 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |