BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 SLIDEMAKER

    MDR report key: 2568718 · Received May 10, 2012

    Report

    Report Number
    1061932-2012-01483
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 15, 2012
    Report Date
    April 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER THAT WHILE THEY RECEIVED FLUID DETECTOR 7 ERRORS FROM THE BECKMAN COULTER LH 750 SLIDEMAKER A 5 ML GREEN FLUID LEAKED FROM UNDER THE INSTRUMENT AND ONTO THE COUNTER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY DOES HAVE A RISK MANAGEMENT / EXPOSURE CONTROL PLAN IS IN PLACE. ON THE DAY OF THE EVENT, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE EVENT. THE FSE FOUND A PROBLEM WITH THE SAMPLE ACCESS MODULE AND REPLACED THE ACCESS RESERVOIR. THE FSE RAN NUMEROUS SAMPLES AND NO ERRORS WERE NOTED. THE SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. SYSTEM VALIDATION DOCUMENTED IN CUSTOMER QC RECORD. THE SAMPLE ACCESS MODULE CARRIES BLOOD, DILUENT AND CLENZ REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 SLIDEMAKER SPINNER, SLIDE, AUTOMATED GKJ BECKMAN COULTER, INC. LH750 SM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1