BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PMIC/ID-107

    MDR report key: 12110325 · Received July 2, 2021

    Report

    Report Number
    1119779-2021-01116
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 4, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486076
    PMA / PMN Number
    K040106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STREPTOCOCCUS MITIS AS STREPTOCOCCUS PNEUMONIAE WHEN USING PHOENIX PANEL PMIC/ID-107 (448607) BATCH NUMBER 0210485. THE CUSTOMER DID NOT RETURN ISOLATES OR PANELS, HOWEVER DID RETURN LAB REPORTS FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF FOUR (4) RETENTION PANELS FROM THE COMPLAINT BATCH AS WELL AS TWO (2) CONTROL PANELS FROM DIFFERENT CATALOG NUMBERS, ONE FROM A PMIC/ID-108 AND ONE FROM A SMIC/ID-101 WERE TESTED USING A PHOENIX 100 INSTRUMENT USING IN HOUSE ISOLATES OF STREPTOCOCCUS MITIS (A2366) AND EVALUATED FOR IDENTIFICATION RESULTS. TWO (2) OF THE FOUR (4) RETENTION PANELS FROM THE COMPLAINT BATCH IDENTIFIED CORRECTLY AS STREPTOCOCCUS MITIS WHILE THE OTHER TWO (2) PANELS IDENTIFIED INCORRECTLY AS STREPTOCOCCUS PNEUMONIAE. BOTH CONTROL PANELS IDENTIFIED CORRECTLY AS STREPTOCOCCUS MITIS. THIS COMPLAINT IS CONFIRMED DUE TO THE TWO RETENTION PANELS FROM THE COMPLAINT BATCH YIELDING INCORRECT IDENTIFICATION RESULTS. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCH.   A REVIEW OF COMPLAINTS REVEALED THREE (3) ADDITIONAL COMPLAINTS FOR THE COMPLAINT BATCH NOT RELATED TO THIS SPECIFIC ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-107 A MISIDENTIFICATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PHOENIX IDENTIFIED ORGANISM AS S. PNEUMONIAE BUT ISOLATE IS P DISK NEGATIVE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-107 A MISIDENTIFICATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PHOENIX IDENTIFIED ORGANISM AS S. PNEUMONIAE BUT ISOLATE IS P DISK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007910 BD PHOENIX PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 448607 0210485 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1