BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® AMYLASE (AMY) REAGENT

    MDR report key: 1840450 · Received September 21, 2010

    Report

    Report Number
    2050012-2010-00814
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    June 18, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JFJ
    PMA / PMN Number
    K883181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARRAY/IMMAGE CALIBRATOR 1 PRODUCT INFORMATION: CATALOG NUMER: 449560, LOT NUMBER: M904529, MANUFACTURING DATE: 10/01/2009, EXPIRATION DATE: 12/31/2010, 510(K): K791341. CALIBRATOR. CLASSIFICATION: CLASS II. JIX, CALIBRATOR, MULTIANALYTE MIXTURE, PANEL: CLINICAL CHEMISTRY. NO OTHER INFORMATION IS AVAILABLE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS DISCOVERED IN THE BECKMAN COULTER INC. (BCI) WAREHOUSE THAT A SYNCHRON AMYLASE REAGENT PACK AND ARRAY/IMAGE CALIBRATOR 1 BOXES WERE DAMAGED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® AMYLASE (AMY) REAGENT AMYLASE TEST SYSTEM JFJ BECKMAN COULTER, INC. NA M001687

    Patients

    Seq Age Sex Outcome Treatment
    1