BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 700 SERIES RETIC PAK

    MDR report key: 2120823 · Received June 11, 2011

    Report

    Report Number
    1061932-2011-00616
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE UNKNOWN.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) TOKYO REPORTED THE LH700 SERIES RETIC PAK HAD DEEP BLUE STAIN ON THE SHIPPING BOX. THE BOTTLE OF RETIC STAIN IN THE BOX WAS TORN ON THE BOTTOM AND PARTIALLY EMPTY. THE OPERATOR WAS WEARING PPE WHILE RECEIVING AND INSPECTING OF THE PRODUCT. REAGENT A IS RETIC STAIN: NEW METHYLENE BLUE IN BUFFERED SOLUTION 0.06% W/V REAGENT B IS RETIC CLEAR: SULFURIC ACID WITH STABILIZERS 0.15% (W/V). NO REPORT OF DEATH, INJURY OR EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE REQUIRED MEDICAL ATTENTION AND NO DIAGNOSTIC TESTING WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH 700 SERIES RETIC PAK LH 700 SERIES RETIC PAK GGK BECKMAN COULTER INC LH 700 SERIES RETIC PAK 57147K

    Patients

    Seq Age Sex Outcome Treatment
    1