BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTAMICIN REAGENT TEST KIT

    MDR report key: 2515585 · Received April 3, 2012

    Report

    Report Number
    2050012-2012-00842
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LCD
    PMA / PMN Number
    K811692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS OFFERED A NEW REAGENT KIT, BUT DECLINED THE OFFER. THE OTHER CARTRIDGE CONTAINED IN THE SHIPMENT WAS NOT DAMAGED. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES OR HARM BY EXPOSURE AS A RESULT OF THE LEAK. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4). SHIPMENT DAMAGE DETERMINED VIA TELEPHONE

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT APPROXIMATELY 20 MILLILITERS OF ONE GENTAMICIN REAGENT CARTRIDGE, LOT # M111207, WAS FOUND LEAKING UPON RECEIPT OF THE ASHES. DAMAGE WAS FOUND ONLY TO THE INTERNAL KIT, BUT NOT TO THE SHIPPING BOX. THE CAUSE OF THE LEAK COULD NOT BE DETERMINED. CUSTOMER WAS ASKED TO EMPTY THE CONTENTS OF THE CARTRIDGE AND TO STORE THE CARTRIDGE USING PROPER LABORATORY PROCEDURES IN THE CASE THAT AN INVESTIGATION OF THE CARTRIDGE DAMAGE WAS NECESSARY. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES. CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID, AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THERE WAS NO IMPACT TO PATIENT SAMPLES OR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTAMICIN REAGENT TEST KIT ENZYME IMMUNOASSAY, GENTAMICIN LCD BECKMAN COULTER, INC. GEN REAGENT M111207

    Patients

    Seq Age Sex Outcome Treatment
    1