BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOPREP¿ REAGENT SYSTEM

    MDR report key: 2194235 · Received August 6, 2011

    Report

    Report Number
    1061932-2011-01000
    Event Type
    Malfunction
    Date Received
    August 6, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    CL. 1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ROOT CAUSE IS LIKELY ATTRIBUTED TO DAMAGED PACKAGING. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT LIQUID HAD LEAKED FROM THE REAGENT A BOTTLE OF THEIR IMMUNOPREP REAGENT SYSTEM. THE CUSTOMER REPORTED THAT THE CAP TO THE REAGENT A BOTTLE WAS NOT LOOSE. THE PRODUCT WAS QUARANTINED AFTER THE LEAK WAS DISCOVERED. 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. THERE WAS NO EXPOSURE TO THE CUSTOMER. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE CUSTOMER'S FACILITY. THE CUSTOMER REVIEWED 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 LIKELY ATTRIBUTED TO DAMAGED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOPREP¿ REAGENT SYSTEM RED CELL LYSING REAGENT GGK BECKMAN COULTER, INC. 1099051K

    Patients

    Seq Age Sex Outcome Treatment
    1