BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 12249906 · Received July 29, 2021

    Report

    Report Number
    1119779-2021-01244
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 1, 2021
    Report Date
    June 7, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904486075
    PMA / PMN Number
    K040106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY/ THIS COMPLAINT IS FOR MISIDENTIFICATION OF ALPHA HEMOLYTIC STREP AS ARCANOBACTERIUM WHEN USING PHOENIX PANEL PMIC/ID-107 (448607) BATCH NUMBER 0210485. THE CUSTOMER DID NOT PROVIDE PANELS, ISOLATES, OR LAB REPORTS FOR INVESTIGATION. IT IS TO BE NOTED THAT THE COMPLAINT BATCH WAS NOT AVAILABLE AT THE TIME OF INVESTIGATION. TO INVESTIGATE, A TOTAL OF FOUR RETENTION PANELS FROM THE SAME CATALOG NUMBER AS THE COMPLAINT BATCH, BUT DIFFERENT CATALOG NUMBER WERE TESTED USING BD ISOLATES OF STREPTOCOCCUS GALLOLYTICUS (POS1132) AND ARCANOBACTERIUM HAEMOLYTICUM (A9345) ON A PHOENIX INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. TWO PANELS WERE RUN WITH STREPTOCOCCUS GALLOLYTICUS (POS1132) ISOLATE AND TWO PANELS WERE TESTED USING ARCANOBACTERIUM HAEMOLYTICUM (A9345). DURING INVESTIGATION, ALL PANELS IDENTIFIED CORRECTLY. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED FOUR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-107 MISIDENTIFICATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A REFERENCE LAB TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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 MIS ID OF ALPHA HEMOLYTIC STREP AS A ARCANOBACTERIUM. "

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 MISIDENTIFICATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A REFERENCE LAB TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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 MIS ID OF ALPHA HEMOLYTIC STREP AS A ARCANOBACTERIUM. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146156 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 0210485 00382904486075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown