BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2TESTOSTERONE CAL, S0-S5

    MDR report key: 2013344 · Received March 10, 2011

    Report

    Report Number
    2122870-2011-00643
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CDZ
    PMA / PMN Number
    K001935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO LEAKAGE DETECTED WITHIN THE CARDBOARD CALIBRATOR BOX. THE CALIBRATOR WAS RECEIVED BY THE CUSTOMER ON (B)(6) 2010. THE CALIBRATOR EXPIRATION DATE IS 31 JULY, 2011.NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ATTEMPTING TO OPEN A S3 CALIBRATOR VIAL FROM A TESTOSTERONE CALIBRATOR KIT WHEN THE VIAL NECK "BROKE OFF".IT WAS REPORTED BY THE USER THAT NO INJURY HAD OCCURRED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2TESTOSTERONE CAL, S0-S5 TESTOSTERONE CALIBRATOR CDZ BECKMAN COULTER INC. NA 015601

    Patients

    Seq Age Sex Outcome Treatment
    1