BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOPREP¿ REAGENT SYSTEM

    MDR report key: 2194234 · Received August 6, 2011

    Report

    Report Number
    1061932-2011-00999
    Event Type
    Malfunction
    Date Received
    August 6, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    CL. 1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ROOT CAUSE ATTRIBUTED TO REPORTED MISSING FOIL SEAL ON THE REAGENT A BOTTLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT REAGENT A HAD NO FOIL SEAL ON THE BOTTLE AND LIQUID HAD LEAKED OUT OF THEIR IMMUNOPREP REAGENT SYSTEM. THE CUSTOMER REPORTED THAT THE REAGENT A HAD LEAKED WITHIN THE BOX. THE BOX WAS DISPOSED OF PER LOCAL GUIDELINES AND DAILY DISPOSAL METHODS. THERE WAS NO IMPACT TO PATIENT RESULTS. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. THE CUSTOMER REPORTED THAT THERE WAS NO EXPOSURE AND NO HAZARDOUS MATERIAL CLEANUP WAS REQUIRED. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THE CUSTOMER DID NOT REVIEW THE MATERIAL SAFETY DATA SHEET (MSDS). REAGENT A IS A SKIN AND EYE IRRITANT AND CLASSIFIED AS HAZARDOUS (CHEMICAL EXPOSURE) BY THE US OSHA. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO THE REPORTED MISSING FOIL SEAL ON THE REAGENT A BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOPREP¿ REAGENT SYSTEM RED CELL LYSING REAGENT GGK BECKMAN COULTER, INC. 1099052K

    Patients

    Seq Age Sex Outcome Treatment
    1