BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® OSTASE CALIBRATOR

    MDR report key: 1982594 · Received February 9, 2011

    Report

    Report Number
    2122870-2011-00203
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JIS
    PMA / PMN Number
    K994278
    Removal / Correction Number
    Z-2605-6-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF DAMAGED OSTASE QC AND CALIBRATOR VIALS WAS CONDUCTED AT BCI. IT WAS DETERMINED THAT THE GLASS VIALS ARE NOT COMPATIBLE TO FREEZING AT -70ºC.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO DAMAGED ACCESS OSTASE CALIBRATOR VIALS, WHICH LEAKED THE CONTENT. TWO CALIBRATOR BOXES WERE AFFECTED BY THE TWO DAMAGED OSTASE CALIBRATOR VIALS. THE CUSTOMER DID NOT REPORT EFFECT TO PATIENTS OR END USERS IN ASSOCIATION TO THIS EVENT.

    Description of Event or Problem · 1

    ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® OSTASE CALIBRATOR CALIBRATOR, PRIMARY JIS BECKMAN COULTER, INC. NA 018854

    Patients

    Seq Age Sex Outcome Treatment
    1