BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® ALKALINE PHOSPHOTASE (ALP)

    MDR report key: 2152785 · Received July 7, 2011

    Report

    Report Number
    2050012-2011-02885
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CJE
    PMA / PMN Number
    K971333
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THEY DID NOT NEED REPLACEMENT. SERVICE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A BROKEN ALKALINE PHOSPHOTASE (ALP) CARTRIDGE THAT WAS FOUND WHILE REMOVING THE REAGENT FROM THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER DID NOT KNOW IF THE CARTRIDGE HAD ANY SIGNS OF DAMAGE PRIOR TO LOADING ONTO THE INSTRUMENT. THE CUSTOMER NOTICED THAT THE VOLUME STATUS REDUCED SOONER THAN IT WAS SUPPOSED TO WHICH PROMPTED THE CUSTOMER TO REMOVE THE CARTRIDGE. NO INJURY WAS REPORTED AND NO FALSE PATIENT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® ALKALINE PHOSPHOTASE (ALP) ALKALINE PHOSPHOTASE CJE BECKMAN COULTER INC. NA M101617

    Patients

    Seq Age Sex Outcome Treatment
    1