BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT

    MDR report key: 2251981 · Received September 16, 2011

    Report

    Report Number
    1628664-2011-00621
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Report Date
    September 6, 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
    GM
    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 OBSERVED BLACK MOLD IN CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT LOT 62474UN10 AND REQUESTED REPLACEMENT OF THE REAGENT. THE CUSTOMER DISCARDED THE AFFECTED REAGENT AND 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 C8000, LIST # (B)(4), SN (B)(4)