BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIFF AC*T TAINER

    MDR report key: 2218105 · Received August 21, 2011

    Report

    Report Number
    1061932-2011-01246
    Event Type
    Malfunction
    Date Received
    August 21, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GGK
    PMA / PMN Number
    CLAS1 EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACT DIFF TAINER KIT WAS REPLACED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE OF THE LEAK IS UNKNOWN. BEC INTERNAL IDENTIFICATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT RECEIVING A BOX OF THE ACT DIFF TAINER THAT LEAKED LYTIC REAGENT. THE ACT DIFF TAINER BOX WAS NOT OPENED AND THE CUSTOMER DID NOT KNOW IF THE SEAL WAS ON THE BOTTLE. THE LEAK WAS ABSORBED BY THE ACT DIFF TAINER BOX. THE PRODUCT WAS DISCARDED. THE USER DID NOT WEAR PPE AT THE TIME OF THE INCIDENT. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIFF AC*T TAINER RED CELL LYSING REAGENT GGK BECKMAN COULTER INC. DIFF ACT TAINER 115130K

    Patients

    Seq Age Sex Outcome Treatment
    1