BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS ALKALINE PHOSPHATASE (ALP) REAGENT

    MDR report key: 2233730 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-04766
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 5, 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
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE SYNCHRON SYSTEMS ALKALINE PHOSPHATASE (ALP) REAGENT WAS LEAKING FROM THE BOTTOM SEAM OF THE CARTRIDGE. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® SYSTEMS ALKALINE PHOSPHATASE (ALP) REAGENT NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES CJE BECKMAN COULTER INC. N/A T011168

    Patients

    Seq Age Sex Outcome Treatment
    1