BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEG URINE COMBO 61

    MDR report key: 4948145 · Received July 28, 2015

    Report

    Report Number
    2919016-2015-00102
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    April 26, 2015
    Report Date
    June 29, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    LQM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PARTICIPATED IN THE SAME PROFICIENCY SURVEY USING (B)(4) 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. PLEASE REFER TO MEDWATCH REPORT NUMBERS 2919016-2015-00100 AND 2919016-2015-00101 FOR REPORTS OF SIMILAR EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE (B)(6) SURVEY ISOLATE WAS TESTED THREE DIFFERENT TIMES USING NEG URINECOMBO 61 PANELS (LOT NUMBERS NOT PROVIDED). THE ISOLATE WAS IDENTIFIED AS LEMINORELLA SP. 93.14%. THE CORRECT ID OF THE ISOLATE WAS SHIGELLA BOYDII PER (B)(4) BACTERIOLOGY PARTICIPANT SUMMARY REPORT. IT WAS REPORTED THAT THE BIOCHEMICAL QC WAS WITHIN SPECIFICATION BOTH BEFORE AND AFTER THE THIRD TEST EVENT. THERE WAS NO PATIENT INVOLVED AS THIS WAS A PROFICIENCY SURVEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492070 NEG URINE COMBO 61 MICRO DILUTION PANEL LQM BECKMAN COULTER N/A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1