BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PHOENIX PMIC/ID 69

    MDR report key: 11302270 · Received February 9, 2021

    Report

    Report Number
    1119779-2021-00278
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    January 15, 2021
    Report Date
    February 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR THE MIS-IDENTIFICATION OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS EPIDERMIDIS WHEN USING PHOENIX PANELPMIC/ID 69 (448761) BATCH 0231274 WITH PATIENT ISOLATES. DUE TO THIS FALSE IDENTIFICATION THE CLIENT REPORTED THAT WRONG TREATMENT WAS ADMINISTERED TO THE PATIENT. QC RESULTS FOR THE PANEL WAS SATISFACTORY. THE CUSTOMER PROVIDED LAB REPORT RESULTS FOR INVESTIGATION; NO PRODUCT OR ISOLATE RETURNS WERE PROVIDED. THERE HAVE BEEN NO CONFIRMED COMPLAINTS FOR THIS DEFECT IN THE LAST YEAR. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED ON THE COMPLAINT LOT. COMPLAINT TRENDING WAS PERFORMED AND A TREND WAS FOUND FOR AN INCREASED RATE OF COMPLAINTS FOR THIS DEFECT (S. AUREUS IDENTIFYING AS S. EPIDERMIDIS) IN (B)(6) 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. THE PHOENIX¿ USER¿S MANUAL STATES IDENTIFICATION ACCURACY OF 95.6% AND 95.4% FOR GRAM-NEGATIVE AND GRAM-POSITIVE ORGANISMS RESPECTIVELY. THREE RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING QC AND IN-HOUSE ISOLATES OF S. AUREUS. THESE PANELS ALL YIELDED THE CORRECT IDENTIFICATION RESULT OF S. AUREUS. THIS COMPLAINT IS NOT CONFIRMED. SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PHOENIX¿ PMIC/ID 69 THERE WAS A MISIDENTIFICATION WHERE S. AUREUS WAS IDENTIFIED BY INSTRUMENT AS S. EPIDERMIDIS. PLATE WAS OBSERVED AND LAB TECHNICIAN CORRECTED TO S. AUREUS BUT NOT THE ANTIBIOGRAM, THEREFORE A RESULT OF OXACILLIN RESISTANT S. AUREUS WAS REPORTED. AS A RESULT, THE PATIENT¿S TREATMENT WAS CHANGED TO VANCOMYCIN FOR A DAY UNTIL THE ID NOTICED THAT THERE WAS A SECOND ISOLATE THAT WAS OXACILLIN SENSITIVE AND AFTER AN INTERNAL INVESTIGATION IN THE LAB THE ERROR WAS FOUND AND TREATMENT DE-ESCALATED TO ANOTHER ANTIBIOTIC. BECAUSE VANCOMYCIN WAS ONLY ADMINISTERED FOR 24 HOURS, NO HARM CAME TO THE PATIENT OTHER THAN THE EXPOSURE ITSELF TO A MORE TOXIC ANTIBIOTIC FOR 24 HOURS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH BD PHOENIX¿ PMIC/ID 69 THERE WAS A MISIDENTIFICATION WHERE S. AUREUS WAS IDENTIFIED BY INSTRUMENT AS S. EPIDERMIDIS. PLATE WAS OBSERVED AND LAB TECHNICIAN CORRECTED TO S. AUREUS BUT NOT THE ANTIBIOGRAM, THEREFORE A RESULT OF OXACILLIN RESISTANT S. AUREUS WAS REPORTED. AS A RESULT, THE PATIENT¿S TREATMENT WAS CHANGED TO VANCOMYCIN FOR A DAY UNTIL THE ID NOTICED THAT THERE WAS A SECOND ISOLATE THAT WAS OXACILLIN SENSITIVE AND AFTER AN INTERNAL INVESTIGATION IN THE LAB THE ERROR WAS FOUND AND TREATMENT DE-ESCALATED TO ANOTHER ANTIBIOTIC. BECAUSE VANCOMYCIN WAS ONLY ADMINISTERED FOR 24 HOURS, NO HARM CAME TO THE PATIENT OTHER THAN THE EXPOSURE ITSELF TO A MORE TOXIC ANTIBIOTIC FOR 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198365 BD PHOENIX PMIC/ID 69 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 0231274

    Patients

    Seq Age Sex Outcome Treatment
    1 Other