PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2023-00497
- Event Type
- Malfunction
- Date Received
- April 28, 2023
- Date of Event
- April 4, 2023
- Report Date
- June 16, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- K181665
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6. INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA BOYDII WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 2263149. THE CUSTOMER DID NOT PROVIDE ISOLATES, PANEL RETURNS OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. PANEL BATCH 2263149 WAS NOT AVAILABLE FOR INVESTIGATION TESTING, AND A COMPARABLE BATCH, 2256574, WAS USED FOR INVESTIGATION TESTING. TO INVESTIGATE, ONE RETENTION SAMPLE FROM COMPLAINT BATCH 2256574 WAS INOCULATED WITH QC ISOLATE E. COLI A25922 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR IDENTIFICATION RESULTS. ALSO, ONE RETENTION SAMPLE FROM COMPLAINT BATCH 2256574 WAS INOCULATED WITH QC ISOLATE E. COLI A35218 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR IDENTIFICATION RESULTS. LAST, ONE RETENTION SAMPLE FROM COMPLAINT BATCH 2256574 WAS INOCULATED WITH QC ISOLATE E. COLI 18180 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR IDENTIFICATION RESULTS. THE INVESTIGATION RETURNED ALL THREE PANELS IDENTIFYING AS E.COLI . THEREFORE, THIS COMPLAINT IS NOT 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. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED TWO ADDITIONAL COMPLAINTS ON BATCH 2263149, ONE OF WHICH IS RELATED TO THIS DEFECT AND NOT CONFIRMED. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-307 MISIDENTIFIED E. COLI FOR SHIGELLA BOYDII. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED AN ISOLATE OF E. COLI WAS MISIDENTIFIED AS SHIGELLA BOYDII.
IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-307 MISIDENTIFIED E. COLI FOR SHIGELLA BOYDII. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED AN ISOLATE OF E. COLI WAS MISIDENTIFIED AS SHIGELLA BOYDII.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466211 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON, DICKINSON & CO. (SPARKS) | 449289 | 2263149 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |