BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEG COMBO PANEL TYPE 50

    MDR report key: 4903986 · Received July 9, 2015

    Report

    Report Number
    2919016-2015-00095
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    LQM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PARTICIPATED IN THE SAME PROFICIENCY SURVEY USING D-04 2015 (B)(6) SURVEY ISOLATE. WHEN TESTED ON CONVENTIONAL OVERNIGHT PANELS AND READ ON THE WA INSTRUMENT, AN ID OF LEMINORELLA SP. 93.14% WAS ATTAINED. WHEN THE SAME PANEL WAS READ ON THE AUTOSCAN-4 (AS-4) INSTRUMENT, AN ID OF SHIGELLA SP. 99.30% WAS ATTAINED. THE DIFFERENCE BETWEEN THE TWO READS WAS THE CF8 (CEPHALOTHIN 8 (UG/ML) WELL; THE CF8 WELL WAS NEGATIVE ON THE WA AND POSITIVE ON THE AS-4. IT WAS NOTED THAT THE CF8 WELL WAS A WEAK POSITIVE WHEN VISUALLY VERIFIED. THE RESULTS FROM THE CF8 PANEL ALONG WITH THE PANEL RESULTS FROM THE OTHER BIOCHEMICALS/ANTIMICROBICS ARE USED TO GENERATE THE BIOTYPE NUMBER FOR THE ORGANISM TESTED AND THE CORRESPONDING IDENTIFICATION. AN ID OF SHIGELLA WAS ALSO ATTAINED ON TWO ADDITIONAL TESTS USING RAPID NEGATIVE PANELS. ALSO, THE SAMPLE WAS TESTED ON AN ANALYTICAL PROFILE INDEX (API) STRIP AS A REFERENCE TEST METHOD AND A LOW PROBABILITY ID OF SHIGELLA SP. WAS ATTAINED. IT IS POSSIBLE THAT EMERGING RESISTANCE WITH THIS ORGANISM MAY BE CONTRIBUTING TO THE IDENTIFICATION DISCREPANCY. REVIEW OF THE SUBMITTED DATA FROM THE CUSTOMER REVEALED THAT THE ISOLATE WAS OXIDASE POSITIVE, THE MANUFACTURER INTERNAL TESTING INDICATED NEGATIVE. INDOLE WAS NEGATIVE ON THREE OF THE FOUR PANELS WHICH ARE CONSISTENT WITH THE MANUFACTURER INTERNAL TESTING. IF THE OXIDASE WAS CHANGED TO NEGATIVE ON THE TWO PANELS WITH LOW PROBABILITY IDENTIFICATION OF VIBRIO HOLLISAE 79.8%, THE IDENTIFICATION WOULD CHANGE TO THE LEMINORELLA SP. IF THE OXIDASE WAS CHANGED TO NEGATIVE ON THE OTHER PANEL WITH LOW PROBABILITY IDENTIFICATION OF VIBRIO HOLLISAE 55.50%, THE ID WOULD CHANGE TO SHIGELLA SP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE (B)(6) SURVEY ISOLATE INITIAL RESULT IDENTIFIED THE ISOLATE AS VIBRIO HOLLISAE SP. THE ISOLATE WAS RAN IN FOUR PANELS USING THE NEG COMBO 50 PANEL, 1-PANEL RESULTED TO HIGH PROBABILITY IDENTIFICATION VIBRIO HOLLISAE (90.44%), 2-PANELS RESULTED TO LOW PROBABILITY IDENTIFICATION OF VIBRIO HOLLISAE (79.8%) AND 1-PANEL RESULTED TO LOW PROBABILITY IDENTIFICATION OF VIBRIO HOLLISAE (55.50%). IT WAS REPORTED THAT THE QC WAS WITHIN RANGE BEFORE AND AFTER THE REPORTED MISIDENTIFICATION. THE CORRECT ID OF THE ISOLATE WAS SHIGELLA BOYDII PER 2015 (B)(6) D-A BACTERIOLOGY PARTICIPANT SUMMARY REPORT. THERE WAS NO REPORT INVOLVED AS THIS WAS A PROFICIENCY SURVEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446569 NEG COMBO PANEL TYPE 50 MICRO DILUTION PANEL LQM BECKMAN COULTER N/A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1