BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID CPS ELITE TRANSLUCENT 100 PLT

    MDR report key: 5091648 · Received September 21, 2015

    Report

    Report Number
    3002769706-2015-00096
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    August 27, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JXA
    PMA / PMN Number
    CL I, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    REVIEW OF QC BATCH RECORDS INDICATE CONFORMANCE TO SPECIFICATIONS. DURING THE INVESTIGATION, SIXTY (60) CHROMID TM CPS ELITE AGAR PLATES WERE TESTED; THE PLATES WERE ASSOCIATED WITH THREE (3) DIFFERENT TIMEFRAMES OF THE MANUFACTURING PROCESS FOR THE IDENTIFIED BATCH (11:25, 16:24 AND 19:40). THE PLATES WERE NOT INOCULATED. THE PLATES WERE INCUBATED FOR FIVE (5) DAYS AT 33-37ºC. RESULTS CONFORMED TO SPECIFICATIONS FOR CONTAMINATION; ZERO (0) CONTAMINATIONS OBSERVED IN 60 PLATES. THERE IS NO EVIDENCE OF A CONTAMINATION ISSUE WITH THE CHROMID TM CPS ELITE AGAR PRODUCT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED IN COMPLAINING OF A CONTAMINATE ON (B)(4),CHROMID(TM) CHROMID CPS PLATES, LOT 1004145580 DISCOVERED AFTER INCUBATION. BACTERIUM CONTAMINATION IS PRESENTING AS A BROWNISH-YELLOW UNIDENTIFIED COLONY. CUSTOMER REPORTS NO PATIENT RESULTS WERE AFFECTED. AN INTERNAL INVESTIGATION HAS BEEN LAUNCHED USING RETAINED PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623545 CHROMID CPS ELITE TRANSLUCENT 100 PLT CHROMID CPS ELITE TRANSLUCENT 100 PLT JXA BIOMERIEUX SA 1004145580

    Patients

    Seq Age Sex Outcome Treatment
    1