BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-CAL HEMATOLOGY CALIBRATOR

    MDR report key: 2535384 · Received April 13, 2012

    Report

    Report Number
    1061932-2012-01211
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 22, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    KRY
    PMA / PMN Number
    K862122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN INTERNAL BECKMAN COULTER EMPLOYEE REPORTED THE S-CAL HEMATOLOGY CALIBRATOR PACKAGE WAS RECEIVED WITH A REDDISH SMUDGE ON THE PACKAGE INSERT AND THE VIAL LABEL. THE EMPLOYEE STATED THAT THE PACKAGE WAS INTACT AND THE VIALS WERE SEALED. THE EMPLOYEE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LAB COAT, GLOVES AND EYE PROTECTION DURING THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. THE ROOT CAUSE FOR THE REDDISH SMEAR ON THE PACKAGE INSERT AND VIAL IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-CAL HEMATOLOGY CALIBRATOR CALIBRATOR FOR PLATELET COUNTING KRY BECKMAN COULTER INC. N/A 1158207F

    Patients

    Seq Age Sex Outcome Treatment
    1