BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXH CELL LYSE

    MDR report key: 2463132 · Received February 21, 2012

    Report

    Report Number
    1061932-2012-00562
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, BECKMAN COULTER, INC. (BEC) HAS DETERMINED THAT THE MALFUNCTIONED DEVICE WOULD NOT LIKELY CAUSE DEATH OR SERIOUS INJURY UPON RECUR. BEC HAS DETERMINED THAT THE INCIDENT REPORTED BY THE CUSTOMER WAS NOT AN MDR REPORTABLE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT SHE RECEIVED A BOX OF DXH CELL LYSE 5L THAT WAS LEAKING. CUSTOMER REPORTED THAT THE BOX WAS WET AND OTHER BOXES IN THE SHIPMENT WERE ALSO WET. CUSTOMER REPORTED THAT THE CAP ON THE DXH CELL LYSE 5L BOTTLE WAS NOT ATTACHED SECURELY TO THE BOTTLE. CUSTOMER REPORTED THAT SHE HAD A SMALL CUT ON HER HAND WHICH WAS COVERED BY A BAND AID. CUSTOMER REPORTED THAT SHE DID NOT GET THE FLUID ON HER WOUND. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXH CELL LYSE PRODUCTS, RED-CELL LYSING PRODUCTS GGK BECKMAN COULTER, INC. 1710002

    Patients

    Seq Age Sex Outcome Treatment
    1