BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LYSE S® 4 LYTIC REAGENT

    MDR report key: 1914669 · Received December 3, 2010

    Report

    Report Number
    1061932-2010-00250
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT ON (B)(6) 2010.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEY RECEIVED A SHIPMENT OF COULTER LYSE S 4 LYTIC REAGENT, ON (B)(6) 2010, AND REPORTED A SMALL HOLE IN THE UPPER PART OF THE REAGENT. THERE WAS NO EFFECT TO PATIENT OR USER, AND NO EXPOSURE TO OPEN LESION OR MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LYSE S® 4 LYTIC REAGENT RED-CELL LYSING PRODUCTS (REAGENT) GGK BECKMAN COULTER, INC. LYSE S 4 (REAGENT) T911180

    Patients

    Seq Age Sex Outcome Treatment
    1