BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2032030 · Received March 28, 2011

    Report

    Report Number
    2122870-2011-00820
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REMOVED A LOADED PACK FROM THE INSTRUMENT IN AN ATTEMPT TO "MANUALLY MIX" THE PUNCTURED PACK TO CIRCUMVENT "ULTRASONICS ISSUES". THE CUSTOMER DID NOT RE-SCAN THE PACK BARCODE BEFORE LOADING THE PACK BACK ONTO THE INSTRUMENT. HOTLINE ASSISTED THE CUSTOMER IN LOCATING AND REMOVING THE MISS-LOADED PACK AND THE CUSTOMER VERIFIED THE PACK HAD NOT BEEN SCANNED PRIOR TO RE-LOADING IT. HOTLINE INSTRUCTED THE CUSTOMER ON PROPER PACK LOADING AND MIXING. THE CUSTOMER WAS INSTRUCTED TO DISCARD THE PACK THAT WAS MANUALLY MIXED AND MISS-LOADED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS ROOT CAUSE WAS DETERMINED DURING TROUBLESHOOTING WITH HOTLINE. USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REQUESTING ASSISTANCE FOR REMOVING A MISS-LOADED REAGENT PACK. WHILE INVESTIGATION THE EVENT, BCI HOTLINE DISCOVERED THAT A TROPONIN (ACCU TNI) REAGENT PACK HAD BEEN REMOVED AND RE-LOADED ONTO THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM INCORRECTLY. IT IS UNKNOWN IF ANY PATIENT RESULTS WERE OBTAINED FROM THE MISS-LOADED PACK. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1