BEUDAMED
    FDA Adverse Event Summary report: N

    PK7300 AUTOMATED MICROPLATE SYSTEM

    MDR report key: 1913197 · Received December 2, 2010

    Report

    Report Number
    2050012-2010-01449
    Date Received
    December 2, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    KSZ
    PMA / PMN Number
    BK060024
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) RELOCATED THE PROBE TO AN ALTERNATE POSITION. A CLEAR ROOT CAUSE HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A DRIPPING REAGENT PROBE ON THE PK7300 AUTOMATED MICROPLATE SYSTEM. NO PATIENTS WERE INVOLVED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK7300 AUTOMATED MICROPLATE SYSTEM AUTOMATED MICROPLATE SYSTEM KSZ BECKMAN COULTER MISHIMA K.K. PK7300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1