BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY UREA NITROGEN REAGENT

    MDR report key: 2466720 · Received February 24, 2012

    Report

    Report Number
    1628664-2012-00086
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Report Date
    November 1, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CDQ
    PMA / PMN Number
    K981918
    Removal / Correction Number
    1628664-9/30/11-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4); CONTAMINATION DURING USE (B)(4). THE CAUSE OF THE FALSELY NEGATIVE OR DECREASED CLINICAL CHEMISTRY UREA NITROGEN RESULTS WAS DUE TO VISIBLE PARTICULATE OR VISIBLE MOLD IN THE REAGENT CARTRIDGES. ABBOTT ISSUED A PRODUCT RECALL LETTER TO ALL CUSTOMERS WITH INSTRUCTIONS TO DISCONTINUE USE AND TO DISCARD/DESTROY ANY SUSPECT CARTRIDGES AND ORDER REPLACEMENT REAGENTS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED MOLD IN THE R1 CARTRIDGE OF A PARTIALLY USED CLINICAL CHEMISTRY UREA NITROGEN REAGENT, LOT 97642UN11. THE CUSTOMER STATED NO ERRORS OR PERFORMANCE ISSUES WERE OBSERVED WHEN THE RECALLED REAGENT WAS ON THE ANALYZER. THE CUSTOMER WAS ADVISED TO REMOVE AND DESTROY THE RECALLED REAGENT AND PERFORM A CLEANING PROCEDURE TO THE WASH CUPS. THERE WAS NO KNOWN IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY UREA NITROGEN REAGENT CDQ ABBOTT MANUFACTURING INC 97642UN11

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4000, LIST # 2P24-01, SN (B)(4)