BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY UREA NITROGEN

    MDR report key: 2495346 · Received March 19, 2012

    Report

    Report Number
    1628664-2012-00125
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    January 14, 2012
    Report Date
    January 26, 2012
    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 Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT: NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4), DEVICE: 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 IMPRECISE, ERRATIC QUALITY CONTROL AND PATIENT RESULTS WHEN ARCHITECT UREA NITROGEN REAGENT LOT (B)(4), WHICH HAD BEEN PREVIOUSLY RECALLED, WAS IN USE. THE CUSTOMER STATED THE INITIAL ARCHITECT RESULT WAS QUESTIONED, THEREFORE, THE RESULT WAS CROSS-CHECKED WITH THE DIMENSION XPAND METHOD. THE CUSTOMER PROVIDED AN EXAMPLE OF THE DISCREPANT PATIENT RESULTS AS FOLLOWS: (B)(4), ARCHITECT UREA NITROGEN RESULT = <2 MG/DL, DIMENSION X-PAND RESULT = 185 MG/DL. THE CUSTOMER RELEASED THE DIMENSION XPAND RESULTS TO THE MEDICAL PROVIDER. DUE TO THE CUSTOMER'S PATIENT CONFIDENTIALITY POLICY, THERE IS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. THERE IS NO INFORMATION WHICH REASONABLY SUGGESTS THAT ANY ADVERSE EVENT OCCURRED DUE TO THE UNEXPECTED DELAY OF ARCHITECT RESULTS.

    Devices

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

    Patients

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