PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2023-00060
- Event Type
- Malfunction
- Date Received
- January 23, 2023
- Date of Event
- November 21, 2022
- Report Date
- June 2, 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
H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS CITROBACTER FREUNDII AND SHIGELLA WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 2229685. PANEL BATCH 2229685 WAS UNAVAILABLE AND A COMPARABLE BATCH (2235337) OF THE SAME MATERIAL WAS USED. BATCH 1021658 WAS EXPIRED AT THE TIME OF INVESTIGATION AND NOT USED IN COMPLAINT TESTING. THE CUSTOMER DID NOT RETURN PANELS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED ISOLATES FOR THE INVESTIGATION. EACH OF THE FOUR (4) CUSTOMER RETURNED ISOLATES WERE LABELED AS FL-2, FL-7, FL-8, AND FL-10. TO INVESTIGATE, EACH OF CUSTOMER RETURNED ISOLATES FL-2, FL-7, FL-8, FL-10 WERE RAN ON A BRUKER MALDI FOR IDENTIFICATION RESULTS. ALL FOUR (4) ISOLATES WERE IDENTIFIED AS E.COLI ON THE BRUKER MALDI. THEN EACH OF THE FOUR (4) CUSTOMER RETURNED ISOLATES WERE TESTED ON A PHOENIX M50 WITH RETENTION PANELS FROM COMPLAINT BATCH 2110796 AND RETENTION PANELS FROM THE SAME MATERIAL BUT A DIFFERENT BATCH NUMBER AND EVALUATED FOR IDENTIFICATION RESULTS. DURING INVESTIGATION TESTING, ALL PANELS TESTED YIELDED SATISFACTORY IDENTIFICATION RESULTS. 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 EITHER OF THE COMPLAINT BATCHE 2229685. A REVIEW OF COMPLAINTS REVEALED TWO (2) ADDITIONAL COMPLAINTS ON BATCH 2229685, BOTH OF WHICH ARE UNCONFIRMED AND ONE (1) OF WHICH IS RELATED TO THIS DEFECT. 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. H3 OTHER TEXT : SEE H.10
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 MISIDENTIFICATION HAS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MIS ID.
REPORT 6 OF 6 IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-307 MISIDENTIFICATION HAS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MIS ID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468962 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY | LON | BECTON, DICKINSON & CO. (SPARKS) | 449289 | 2229685 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |