PANEL PHOENIX NMIC/ID-307
Report
- Report Number
- 1119779-2021-01966
- Event Type
- Malfunction
- Date Received
- December 15, 2021
- Date of Event
- November 16, 2021
- Report Date
- July 29, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- LON
- UDI-DI
- 30382904492893
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE BD PHOENIX NMIC-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K032655, K062944, K060444, K063811, K151320, K063301, K031530, K060447, K023634, K020322, K132674, K023858, K071623, K031699, K060447, K024153, K060214, K042932.
H.6. INVESTIGATION SUMMARY: "THIS COMPLAINT IS FOR MISIDENTIFICATION OF SHIGELLA DYSENTERIAE WHEN USING PHOENIX PANEL NMIC/ID-307 (449289) BATCH NUMBER 1251384. THE CUSTOMER DID RETURN PANELS, BUT DID NOT RETURN LAB REPORTS OR ISOLATES FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF SIX CUSTOMER RETURNED PANELS FROM THE COMPLAINT BATCH WERE TESTED USING TWO DIFFERENT IN HOUSE ISOLATES OF SHIGELLA DYSENTERIAE (ENF 9945 AND ENF 9946). THREE PANELS WERE TESTED PER ISOLATE ON A PHOENIX INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. ALL PANELS IDENTIFIED CORRECTLY AS SHIGELLA DYSENTERIAE. THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED TWO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH. 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. BD ENCOURAGES YOU TO CONSIDER THE FOLLOWING PARAMETERS TO OPTIMIZE RESULTS WITHIN YOUR LABORATORY. QC TESTING SHOULD ONLY BE PERFORMED ON 2ND PASS SUBCULTURES AND AVOID USING COLONIES THAT HAVE BEEN SUB-CULTURED MULTIPLE TIMES. ISOLATED COLONIES ARE TO BE USED FOR INOCULATION AND CAREFULLY CHECK PURITY PLATES TO ENSURE THE INOCULUM CONSISTED OF ONE ISOLATE TYPE. OPTIMUM PERFORMANCE COMES FROM USING FRESH 18-24 HOUR, WELL-ISOLATED COLONIES. ENSURE PROPER, SUFFICIENT INOCULUM DENSITY. ALLOW BUBBLES TO DISSIPATE AFTER VORTEXING. PROPERLY CALIBRATE THE BD PHOENIXSPEC¿ NEPHELOMETER WITH IN-DATE MCFARLAND CALIBRATION STANDARDS. USE SWABS WITH MINIMAL FIBER SHED. MAKE THE PROPER INOCULUM DENSITY FOR THE INOCULUM SYSTEM SETTING (I.E., IF PREPARING A 0.25 MCFARLAND INOCULUM, ENSURE THAT THE SYSTEM IS SET TO 0.5 INOCULUM MODE). VOLUME OF ID BROTH SHOULD BE VISUALLY ASSESSED FOR ANY OBVIOUS LOW FILLS. ENSURE PROPER INCUBATION TEMPERATURE AND ENVIRONMENT. USE THE CORRECT MEDIA TYPE AS LISTED AS ACCEPTABLE FOR USE IN THE USER¿S MANUAL. (NOTE - IT IS HELPFUL TO DISCLOSE THE MEDIA TYPE AND VENDOR WHEN PROVIDING THE DETAILS OF THE COMPLAINT). HANDLE PANELS BY ONLY TOUCHING THE SIDES; TOUCHING THE FRONT OR BACK OF THE PANELS MAY CAUSE INTERFERENCE IN THE READINGS AND LEAD TO ERRORS. FOLLOW USER¿S MANUAL INSTRUCTIONS FOR TIME LIMITS ON POURING INOCULATED ID BROTH INTO THE PANEL AND PLACING THE PANEL INTO THE INSTRUMENT; EXTENDED PERIODS OF TIME OUTSIDE OF THE STATED LIMITATIONS MAY YIELD ERRORS. THANK YOU AGAIN FOR CONTACTING BD AND PLEASE CONTINUE TO COMMUNICATE ANY FURTHER CONCERNS."
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE BD PHOENIX NMIC-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K032655, K062944, K060444, K063811, K151320, K063301, K031530, K060447, K023634, K020322, K132674, K023858, K071623, K031699, K060447, K024153, K060214, K042932.
IT WAS REPORTED THAT WHILE TESTING WITH BD PHOENIX¿ NMIC/ID-307, A SPECIMEN WAS INCORRECTLY IDENTIFIED AS SHIGELLA DYSENTERIAE. CONFIRMATORY TESTING WAS PERFORMED WITH THE ENTERIC PATHOGEN KIT FOR THE LUMINEX MANISPHERE AND BCGN, AND THE RESULT WAS E. COLI. THE ERRONEOUS RESULT WAS NOT REPORTED, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THEIR M50 HAS OUTPUT AN ID OF SHIGELLA DYSENTERIAE WITH A CONFIDENCE OF 90% YET THE APPEARANCE OF THE COLONIES ON BOTH TSA AND MAC RESEMBLE THAT OF KLEBSIELLA OR E.COLI AND QUESTIONS THE ID- NMIC/ID 307 PANEL, LOT #1251384.
IT WAS REPORTED THAT WHILE TESTING WITH BD PHOENIX¿ NMIC/ID-307, A SPECIMEN WAS INCORRECTLY IDENTIFIED AS SHIGELLA DYSENTERIAE. CONFIRMATORY TESTING WAS PERFORMED WITH THE ENTERIC PATHOGEN KIT FOR THE LUMINEX MANISPHERE AND BCGN, AND THE RESULT WAS E. COLI. THE ERRONEOUS RESULT WAS NOT REPORTED, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THEIR M50 HAS OUTPUT AN ID OF SHIGELLA DYSENTERIAE WITH A CONFIDENCE OF 90% YET THE APPEARANCE OF THE COLONIES ON BOTH TSA AND MAC RESEMBLE THAT OF KLEBSIELLA OR E.COLI AND QUESTIONS THE ID- NMIC/ID 307 PANEL, LOT #1251384.
IT WAS REPORTED THAT WHILE TESTING WITH BD PHOENIX¿ NMIC/ID-307, A SPECIMEN WAS INCORRECTLY IDENTIFIED AS SHIGELLA DYSENTERIAE. CONFIRMATORY TESTING WAS PERFORMED WITH THE ENTERIC PATHOGEN KIT FOR THE LUMINEX MANISPHERE AND BCGN, AND THE RESULT WAS E. COLI. THE ERRONEOUS RESULT WAS NOT REPORTED, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THEIR M50 HAS OUTPUT AN ID OF SHIGELLA DYSENTERIAE WITH A CONFIDENCE OF 90% YET THE APPEARANCE OF THE COLONIES ON BOTH TSA AND MAC RESEMBLE THAT OF KLEBSIELLA OR E.COLI AND QUESTIONS THE ID- NMIC/ID 307 PANEL, LOT #1251384.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1912307 | PANEL PHOENIX NMIC/ID-307 | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | LON | BECTON, DICKINSON & CO. (SPARKS) | 449289 | 1251384 | 30382904492893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |