BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 18005503 · Received October 25, 2023

    Report

    Report Number
    1119779-2023-01176
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 15, 2023
    Report Date
    March 25, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904494520
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE POSITIVE ESBL RESULTS WITH ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 3192080. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS BUT PROVIDED ISOLATE RETURNS AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW POSITIVE ESBL RESULTS FOR E. COLI FROM A URINE SAMPLE AND BLOOD SAMPLE WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, THREE RETENTION PANELS EACH FROM COMPLAINT BATCH 3192080 WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES E. COLI (BLD) AND E. COLI (URI) AND PLACED IN A PHOENIX M50 TO OBSERVE FOR ESBL RESULTS. ADDITIONALLY, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED CUSTOMER RETURNED ISOLATES E. COLI (BLD) AND E. COLI (URI) AND PLACED IN A PHOENIX M50 TO OBSERVE FOR ESBL RESULTS. DURING THE INVESTIGATION TESTING, TWO OF THE TEN PANELS TESTED CLASSIFIED THE ISOLATES AS ESBL NEGATIVE. THE OTHER EIGHT PANELS RETURNED ESBL POSITIVE OR ATYPICAL ESBL RESULTS. REVIEW OF THE BD TESTING LAB REPORTS, SHOWS THAT CAZ WAS RESISTANT. WHEN ONE OR MORE 3RD/4TH GENERATION CEPHALOSPORINS IS RESISTANT IT WILL REPORT AS AN ATYPICAL ESBL, TRIGGERING RULE 1437. RULE 1437 WAS PUT IN PLACE IN THE BDXPERT SYSTEM TO ALERT THE CUSTOMER TO PERFORM CONFIRMATORY TESTING. FOR FURTHER INVESTIGATION, ESBL CONFIRMATORY TESTING WAS PERFORMED WITH CUSTOMER RETURNED ISOLATE E. COLI (BLD) AS E. COLI (URI) WAS NOT VIABLE AT THE TIME OF ESBL CONFIRMATORY TESTING. A DIFFUSION DISC OF CEFTAZIDIME AND CEFTAZIDIME/CLAVULANIC ACID WERE PLACED ON A MUELLER-HINTON AGAR PLATE INOCULATED WITH E. COLI (BLD) TO OBSERVE FOR ESBL RESULTS. THE INVESTIGATION SHOWED NO DIFFERENCE IN THE INHIBITION ZONE OF THE TWO DISCS, CONFIRMING ESBL NEGATIVE RESULTS FOR E. COLI (BLD) BASED ON THE RESULTS OF THE INVESTIGATION, THIS COMPLAINT IS CONFIRMED FOR FALSE POSITIVE ESBL RESULTS. THE BATCH HISTORY RECORDS WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. A REVIEW OF COMPLAINTS REVEALED NO OTHER COMPLAINTS ON THIS BATCH. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PANEL PHOENIX NMIC-311 THAT THERE WAS ONE FASLE POSITVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS AN ORGANISM TESTING AS FALSE POSITIVE ESBL. PATIENT HAS E. COLI ISOLATED FROM BOTH URINE AND BLOOD. URINE ISOLATE TESTED AS ESBL, BLOOD DID NOT. ORGANISMS WERE SENT TO REFERENCE LAB FOR ALTERNATE METHOD OF TESTING FOR ESBL. THE ORGANISMS TESTED NEGATIVE FOR ESBL ON THE REFERENCE LAB'S MICROSCAN INSTRUMENT. FALSE POSITIVE ESBL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PANEL PHOENIX NMIC-311 THAT THERE WAS ONE "FALSE" "POSITIVE". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS AN ORGANISM TESTING AS FALSE POSITIVE ESBL. PATIENT HAS E. COLI ISOLATED FROM BOTH URINE AND BLOOD. URINE ISOLATE TESTED AS ESBL, BLOOD DID NOT. ORGANISMS WERE SENT TO REFERENCE LAB FOR ALTERNATE METHOD OF TESTING FOR ESBL. THE ORGANISMS TESTED NEGATIVE FOR ESBL ON THE REFERENCE LAB'S MICROSCAN INSTRUMENT. FALSE POSITIVE ESBL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047729 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3192080 00382904494520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown