BEUDAMED
    FDA Adverse Event Summary report: N

    NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE

    MDR report key: 1913204 · Received December 2, 2010

    Report

    Report Number
    2050012-2010-01462
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CJE
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ALKALINE PHOSPHATASE (ALP) REAGENT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE ALKALINE PHOSPHATASE REAGENT CJE BECKMAN COULTER INC. ALP REAGENT M008545

    Patients

    Seq Age Sex Outcome Treatment
    1