BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID(TM) OXA

    MDR report key: 5529019 · Received March 28, 2016

    Report

    Report Number
    3002769706-2016-00060
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Report Date
    March 22, 2016
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JXA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN FRANCE REPORTED A FALSE SUSCEPTIBLE RESULT OF KLEBSIELLA PNEUMONIA OXA 232 ON 3 LOTS WHILE USING CHROMID® OXA. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. RESULTS ARE AS FOLLOWS: FALSE NEGATIVE RESULT WITH THE CUSTOMER STRAIN KLEBSIELLA PNEUMONIA AS ON TWO (2) OTHER LOTS CLOSE TO THE SAME EXPIRATION DATE(13 WEEKS). THE RESULT IS WELL POSITIVE ON LOTS MORE RECENT(</=9 WEEKS). DETERMINATION- ATYPICAL STRAIN NOT DETECTED ON AGED MEDIA. THE LOTS 1004624570 AND 1004554440 CHROMID® OXA 48 MEDIA ARE OPERATING AS INTENDED WHEN TESTED WITH QC STRAINS. TESTING: TMO ETEST® (TEMOCILLIN) AND READ MIC >=1024 INCLUDING THE MACRO COLONIES IN THE INHIBITION ZONE. THERE WAS ALSO AN ELLIPSE OBSERVED TO 256MG/L SO THE EXPRESSION OF THE RESISTANCE WAS HETEROGENEOUS. COMPLAINT HISTORY: COMPLAINT HISTORY WAS REVIEWED WITH NO TRENDS NOTED. IN CONCLUSION, THE FALSE NEGATIVE RESULT IS DUPLICATED IN-HOUSE AND THE MEDIA CHROMID® OXA 48 LOT 1004624570 AND 1004554440. THE SENSITIVITY OF THIS MEDIUM HAS BEEN FIXED AT 95% (SEE PACKAGE INSERT). THIS IS ISOLATED ISSUE. THE DEVICE IS OPERATING WITHIN PRODUCT LIMITATIONS (SENSITIVITY 95%).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE SUSCEPTIBLE RESULT OF KLEBSIELLA PNEUMONIA OXA 232 ON 3 LOTS WHILE USING; CHROMID(TM) OXA. THE CUSTOMER REPEATED THE TEST ON THREE TIMES WITH THE SAME RESULT; A GROWTH ON CHROMID(TM) ESBL BUT NO GROWTH ON CHROMID(TM) OXA 48 20 PLTS. THE FINAL TWO TESTS WERE PERFORMED WITH AN ENRICHMENT WITH 2 DISCS AND OBTAINED THE SAME RESULT OF; ESBL: POSITIVE, OXA: NEGATIVE. THIS KLEBSIELLA PNEUMONIA STRAIN WAS CONFIRMED AS RESISTANT TO TEMOCILLIN (MIC=384 MICRO-G/ML). THIS STRAIN WAS IDENTIFIED AS; KLEBSIELLA PNEUMONIAE OXA 232. THERE WERE NO REPORTS OF PATIENT HARM OR DELAY IN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185504 CHROMID(TM) OXA CHROMID(TM) OXA JXA BIOMÉRIEUX SA 1004624570

    Patients

    Seq Age Sex Outcome Treatment
    1