BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC/ID-123

    MDR report key: 2035010 · Received March 1, 2011

    Report

    Report Number
    1119779-2011-00001
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    LON
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY TESTED A TOTAL OF EIGHT PANELS FROM CUSTOMER RETURNS. TWO OUT OF THE EIGHT PANELS FAILED THE ESBL TEST WITH K. PNEUMONIAE ATCC 700603 WITH A NEGATIVE RESULT. ADD'L RETENTION PANELS WERE TESTED AND PASSED THE ESBL TEST WITH THE EXPECTED POSITIVE RESULT. THE BATCH HISTORY RECORDS WERE EXAMINED AND NO ABNORMALITIES WERE NOTED. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. ADD'L TESTING, OF THE PANELS IN QUESTION, REVEALED A DRUG SWITCH IN WELLS WHICH CONTAINS CEFTAZIDIME/CLAVULANIC ACID AND WHICH CONTAINS CEFOTAXIME/CLAVULANIC ACID. THE CORRECT PANEL LAYOUT SHOULD BE THE REVERSE. THE ROOT CAUSE DETERMINED THAT THE DRUGS WERE SWITCHED DURING THE STOCK SOLUTION PREPARATION. THESE WELLS ARE 2 OF 6 TOTAL WELLS WHICH COMBINE TO CREATE THE ESBL TEST RESULT. THIS WOULD IMPACT E. COLI, K. OXYTOCA AND K. PNEUMONIAE ORGANISMS IDENTIFIED WITH THIS PANEL. THE REMAINING BIOCHEMICAL AND ANTIMICROBIAL WELLS ON THE PANEL USED FOR IDENTIFICATION AND SUSCEPTIBILITY TESTING ARE UNAFFECTED AND CONTINUE TO PERFORM AS EXPECTED. TESTING USING CHARACTERIZED IN HOUSE STRAINS, CONFIRMED THAT THIS DRUG REVERSAL COULD RESULT IN SPORADIC FALSE NEGATIVE OR FALSE POSITIVE ESBL TEST RESULTS. BD WILL BE RECALLING THE PRODUCT AND HAS INITIATED CORRECTIVE ACTION TO PREVENT RECURRENCE OF THIS ISSUE. THIS RECALL WILL BE REPORTED THROUGH THE BALTIMORE DISTRICT OFFICE.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT SPORADIC ESBL (EXTENDED SPECTRUM BETA LACTAMASE) FAILURES WITH QUALITY CONTROL (QC) ORGANISM KLEBSIELLA PNEUMONIAE ATCC 700603. WHILE RUNNING QUALITY CONTROL ON THEIR NEW LOT OF PANELS, THEY HAD 2 OUT OF 5 FAILURES FOR THIS ORGANISM. THE FIRST FAILURE WAS WITH A BRAND NEW SUBCULTURE THAT HAD BEEN PASSED TWICE AND THE SECOND WITH AN OLDER CULTURE. CUSTOMER REPEATED THE QUALITY CONTROL USING A FRESH ORGANISM THINKING THAT THE ORGANISM WAS THE ISSUE. REPEAT TESTING WITH THE NEW ORGANISM PASSED AND THE CUSTOMER BEGAN A NEW 5 DAY VALIDATION. AFTER A FEW DAYS THE CUSTOMER CALLED BACK AND REPORTED THAT THEY WERE AGAIN EXPERIENCING ESBL QC FAILURE. CUSTOMER ALSO REPORTED THAT WHEN RUNNING THE SENSITIVITY ONLY PANELS, THERE WERE NO QC FAILURES. PANELS WERE NOT USED DUE TO QC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PHOENIX PANEL NMIC/ID-123 LON BD DIAGNOSTIC SYSTEMS 0223498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other