BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO PANEL TYPE 34

    MDR report key: 5828313 · Received July 27, 2016

    Report

    Report Number
    2919016-2016-00005
    Event Type
    Malfunction
    Date Received
    July 27, 2016
    Date of Event
    May 26, 2016
    Report Date
    June 30, 2016
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    LTT
    PMA / PMN Number
    K003619
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED PANEL DATA FOR THE REPEAT PANEL TESTED ON 06/30/2016 WAS REVIEWED BY BECKMAN NATIONAL PRODUCT SUPPORT TEAM. DATA INDICATED LINEZOLID (LZD) MIC = 4 (SUSCEPTIBLE). PROCESSED DATA INDICATED HEAVY GROWTH IN THE 1 AND 2 WELLS AND VERY LIGHT GROWTH IN THE 4 WELL, HOWEVER NOT ENOUGH TO ACHIEVE THE THRESHOLD. THE DATA DID NOT INDICATE ANY HARDWARE, PRODUCT, OR SET UP ISSUES. THE SAME ISOLATE WAS SENT TO BECKMAN COULTER FOR TESTING. BECKMAN TECHNICAL SUPPORT LAB (TSL) NOTED ON THE GROWTH PLATES THAT THERE APPEARED TO BE TWO DIFFERENT COLONY TYPES. THE ISOLATE WAS SET UP MULTIPLE TIMES ON POS COMBO PANEL TYPE 34 (PC34) PANELS LOT 2017-01-22 AND ON FROZEN REFERENCE PANELS, MANUFACTURED FOLLOWING CLSI RECOMMENDATIONS. LINEZOLID RESULTS WERE INCONSISTENT, WITH THE ISOLATE TESTING AS LZD SUSCEPTIBLE AND RESISTANT ON MULTIPLE FROZEN REFERENCE PANELS AND PC34 PANELS. THE FAILURE MODE FOR THE FALSE SUSCEPTIBLE LINEZOLID INTERPRETATION COULD NOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION AVAILABLE. THE TESTING INDICATES A POSSIBLE MIXED CULTURE OR ATYPICAL ISOLATE (POTENTIALLY WITH VARIABLE PLASMID-MEDIATED RESISTANCE) WHICH COULD BE CONTRIBUTING TO THE DISCREPANT RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE SUSCEPTIBLE LINEZOID (LZD) RESULT WAS OBTAINED ON POS COMBO PANEL TYPE 34 LOT 2017-01-22 FOR A STAPHYLOCOCCUS CAPITIS ISOLATE. THE ISOLATE WAS A (B)(6). (B)(6) EXPECTED A RESISTANT LZD INTERPRETATION FOR THE ISOLATE. THE CUSTOMER INITIAL TEST OF THE ISOLATE ON (B)(6) 2016 OBTAINED THE CORRECT IDENTIFICATION OF STAPHYLOCOCCUS CAPITIS AND THE LZD MIC WAS 4 (SUSCEPTIBLE). REPEAT TEST OF THE SAME ISOLATE PERFORMED ON (B)(6) 2016 OBTAINED THE SAME RESULTS. THE CUSTOMER STATED THEY USED PROMPT METHOD FOR BOTH PANEL SET-UPS. THE PANELS WERE VISUALLY VERIFIED BY THE CUSTOMER AND THE CUSTOMER AGREED WITH THE INSTRUMENT READS. CUSTOMER CONFIRMED PANEL QC AND INSTRUMENT DIAGNOSTICS WERE ALL IN RANGE FOR BOTH WEEKS THE (B)(6) ISOLATE WAS TESTED. THERE WAS NO PATIENT INVOLVED AS THIS WAS A PROFICIENCY SURVEY ISOLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479734 POS COMBO PANEL TYPE 34 MICRO DILUTION PANEL LTT BECKMAN COULTER INC N/A 2017-01-22

    Patients

    Seq Age Sex Outcome Treatment
    1