BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2092666 · Received May 18, 2011

    Report

    Report Number
    2122870-2011-01392
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER SUPPORT HOTLINE FOUND THAT THE CUSTOMER'S FT3 REAGENT PACK WAS SHARED BETWEEN THE CUSTOMER'S TWO DXI 800 SYSTEMS. WHEN THE PACK IS SHARED, THE INSTRUMENT DOES NOT DETECT THAT THE PACK TEST COUNT IS INCORRECT. A PRODUCT CORRECTIVE ACTION LETTER PER BCI (B)(4) WAS DISTRIBUTED (B)(4) 2010 TO ALL NACO ACCESS AND UNICEL DXI CUSTOMERS. THE LETTER WARNS THAT ERRONEOUS RESULTS CAN BE PRODUCED IF REAGENT PACKS ARE NOT LOADED PROPERLY. INCLUDED IN THE DISTRIBUTION IS A WARNING LABEL FOR THE CUSTOMER TO AFFIX TO THE REAGENT PACK LOADING AREA OF THEIR SYSTEMS AND A LAMINATED REAGENT PACK LOADING GUIDE TO KEEP NEAR THEIR INSTRUMENT. THE CUSTOMER DISCARDED THE REAGENT PACK AND CONFIRMED THE PACK LOAD WARNING LABELS INCLUDED IN THE (B)(4) MAILING WERE APPROPRIATELY FIXED ONTO BOTH INSTRUMENTS. ROOT CAUSE IS ASSOCIATED WITH USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM GENERATED A MESSAGE OF REAGENT PACK MONITORING FAILURE IN THE EVENT LOG. THERE WERE NO PATIENT SAMPLES ANALYZED ON THE SHARED REAGENT PACK DURING THE EVENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1