BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS WASH BUFFER II

    MDR report key: 2252392 · Received September 17, 2011

    Report

    Report Number
    2122870-2011-03773
    Event Type
    Malfunction
    Date Received
    September 17, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT WAS SENT TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    REPLACEMENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT RECEIVING ONE DXI WASH BUFFER II CUBETAINER THAT LEAKED. THE CUSTOMER DID NOT QUESTION ANY PATIENT RESULTS. NO INJURY OR AFFECT TO PATIENT OR END USER IN ASSOCIATION WITH THIS EVENT WAS REPORTED. PER VISUAL INSPECTION OF THE PHOTO BY THE INVESTIGATOR, THE LEAKED APPEARED TO BE A PIN HOLE LEAK AND NOT A STRESS CRACK. THE PIN HOLE LEAK CAN BE CAUSED BY A SMALL CRACKS OR CRAZE MARKS DURING THE CUBETAINER INFLATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS WASH BUFFER II REAGENT, GENERAL PURPOSE LDT BECKMAN COULTER INC. WASH BUFFER II 331814F

    Patients

    Seq Age Sex Outcome Treatment
    1