BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1562342 · Received December 21, 2009

    Report

    Report Number
    2122870-2009-00386
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Date of Event
    December 3, 2009
    Report Date
    December 21, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LTJ
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. A SYSTEM CHECK PERFORMED ON 12/02/2009 PASSED WITHIN INSTRUMENT SPECIFICATIONS. REVIEW OF THE CUSTOMER'S REAGENT INVENTORY REPORTS FROM THIS INSTRUMENT AND ANOTHER INSTRUMENT DO SHOW REAGENT PACKS LOADED ON BOTH INSTRUMENTS. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. ALTHOUGH PACK SHARING MAY HAVE CONTRIBUTED TO THE ERRONEOUSLY LOW RESULT, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A PATIENT SAMPLE WAS TESTED FOR HYB- PROSTATE SPECIFIC ANTIGEN (HYB-PSA) AND A RESULT OF 0.00NG/ML WAS OBTAINED. UPON REPEAT TESTING THE HYB-PSA RESULT WAS ABOVE THE NORMAL REFERENCE RANGE (7NG/ML). THE RESULTS WERE REPORTED OUT OF THE LAB. 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 LTJ BECKMAN COULTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1