BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT

    MDR report key: 2250927 · Received September 16, 2011

    Report

    Report Number
    1628664-2011-00615
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 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 MOLD IN THE R2 REAGENT OF CLINICAL CHEMISTRY ALKALINE PHOSPHATASE REAGENT LOT 62474UN10. THE CUSTOMER WAS SENT A REPLACEMENT LOT OF REAGENT. 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 C4000, LIST # 2P24-40, SN# (B)(4)