BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT

    MDR report key: 2247481 · Received September 14, 2011

    Report

    Report Number
    1628664-2011-00609
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CJE
    PMA / PMN Number
    K981806
    Removal / Correction Number
    1628664-8/29/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENTS FAILED TO CALIBRATE/GENERATE RESULTS WAS DUE TO VISIBLE PARTICULATE OR VISIBLE MOLD IN THE REAGENT CARTRIDGES. ABBOTT ISSUED A PRODUCT RECALL LETTER TO ALL CUSTOMERS TO INFORM THEM TO DISCONTINUE USE AND TO DISCARD/DESTROY ANY SUSPECT CARTRIDGES AND ORDER REPLACEMENT REAGENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REJECTED THE USE OF CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT LOT 62474UN10 DUE TO FUNGAL GROWTH, DARKENED REAGENT COLOR, AND PARTICULATES IN RANDOM REAGENT CARTRIDGES. THE AFFECTED REAGENT WAS NOT USED ON ANY ANALYZER IN THE LAB AND WAS HELD BACK FROM BEING IMPLEMENTED FOR CLINICAL USE. THE CUSTOMER WAS SENT REPLACEMENT REAGENTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT CJE ABBOTT MANUFACTURING INC 62474UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000, LIST # 3L77-01, SERIAL # (B)(4)