BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX SMIC/ID-101

    MDR report key: 11786949 · Received May 6, 2021

    Report

    Report Number
    1119779-2021-00775
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904488025
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STREPTOCOCCUS PNEUMONIAE AS STREPTOCOCCUS MITIS WHEN USING PHOENIX PANEL SMIC/ID-101 (448802) BATCH NUMBER 0203650. THE CUSTOMER DID NOT PROVIDE SAMPLES, ISOLATES, OR LAB REPORTS FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF TWO (2) RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING QC ISOLATES OF STREPTOCOCCUS PNEUMONIAE (A49619). BOTH PANELS TESTED DURING INVESTIGATION IDENTIFIED CORRECTLY AS STREPTOCOCCUS PNEUMONIAE. SINCE THE IDENTIFICATION RESULTS YIELDED DURING INVESTIGATION WERE SATISFACTORY THE COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED THREE (3) ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH THAT ARE UNRELATED TO THIS COMPLAINT. COMPLAINT TRENDING WAS PERFORMED AND A TREND WAS FOUND FOR THIS DEFECT (S. PNEUMONIAE IDENTIFYING AS S. MITIS) IN FEBRUARY 2020. BASED ON THE SEVERITY AND RATE OF THE DEFECT, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS NOT INITIATED. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT, INCLUDING CHANGES IN SEVERITY AND RATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ SMIC/ID-101 A MIS-ID WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT MIS-ID OF STREP PEUNO TO STREP MITIS OCCURRED. NITASHA ASSI : 2021-04-12 18:07:55 (GMT) ¯ CUSTOMER PROBLEM: CUSTOMER REPORTING MIS-ID OF STREP PEUNO TO STREP MITIS."

    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. PMA / 510(K)#: THE BD PHOENIX¿ SMIC/ID-101 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K050745, K050747, K050780, K050865, K050881, K050946, K050982, K051109, K051138, K051204, K051266, K051272, K051692, K062206.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ SMIC/ID-101 A MIS-ID WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT MIS-ID OF STREP PEUNO TO STREP MITIS OCCURRED. (B)(6) 2021 18:07:55 (GMT) CUSTOMER PROBLEM: CUSTOMER REPORTING MIS-ID OF STREP PEUNO TO STREP MITIS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678540 BD PHOENIX SMIC/ID-101 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 448802 0203650 30382904488025

    Patients

    Seq Age Sex Outcome Treatment
    1