BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® HLH CALIBRATORS

    MDR report key: 1980816 · Received February 7, 2011

    Report

    Report Number
    2122870-2011-00201
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    December 31, 2010
    Report Date
    December 31, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CEP
    PMA / PMN Number
    K940549
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVIDENCE THAT THE KIT BOX ITSELF HAD BEEN DAMAGED. THE LH CALIBRATOR KIT WAS DISCARDED ALONG WITH THE CRACKED VIAL. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO AN ACCESS HLH CALIBRATOR KIT IN WHICH THE S4 VIAL WAS CRACKED UPON RECEIVING. THE CONTENTS HAD LEAKED AND DRIED ENCRUSTING THE OUTSIDE THE VIAL. THE CUSTOMER DID NOT REPORT EFFECT TO PATIENTS OR END USERS IN ASSOCIATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® HLH CALIBRATORS LUTEINIZING HORMORNE CEP BECKMAN COULTER, INC. NA 008546

    Patients

    Seq Age Sex Outcome Treatment
    1