BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® PREPPLUS 2 CYTOMERTY

    MDR report key: 2001337 · Received February 25, 2011

    Report

    Report Number
    1061932-2011-00100
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LOQ
    PMA / PMN Number
    CLASS1 EXMPT
    Removal / Correction Number
    2050012-01/24/2011-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROL INFORMATION PRIOR TO AND AFTER THE EVENT WAS NOT PROVIDED. SAMPLE INFORMATION WAS NOT PROVIDED FOR THIS EVENT. SERVICE CALL WAS GENERATED. SERVICE DISCUSSED PCA WITH CUSTOMER ((B)(4)).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORT THE INSTRUMENT DID NOT ALERT THE OPERATOR WHEN THE ANTIBODY REAGENT (KAPPA AND LAMBA REAGENT) VIALS WERE EMPTY. THE INSTRUMENT CONTINUED WITHOUT DISPENSING REAGENT FROM THE EMPTY VIAL INTO THE DAUGHTER TUBES. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. THE ISSUE WAS DISCOVERED UPON REVIEW OF THE RESULTS FROM THE FC 500. . NO REPORTS OF DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® PREPPLUS 2 CYTOMERTY COULTER® PREPPLUS 2 LOQ BECKMAN COULTER INC. PREP PLUS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1