BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2182463 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02556
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. THE SAMPLE WAS COLLECTED AT A SATELLITE CLINIC. THE SAMPLE OBTAINED FROM (B)(4) 2011 (1/1) WAS DISCARDED AFTER INITIAL ANALYSIS. PER THE CUSTOMER SUPPLIED QC CHARTS, LEVEL 1 HYB-PSA QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. ADDITIONAL QC INFORMATION HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK PERFORMED ON (B)(4) 2011 PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THE TIME OF CONTACT WITH BEC.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) OF OBTAINING A HIGHER THAN EXPECTED HYBRITECH PROSTATE-SPECIFIC ANTIGEN (HYB-PSA) RESULT FOR ONE (1) PATIENT. THE RESULT WAS ABOVE THE NORMAL REFERENCE RANGE THAT DID NOT MATCH THE PATIENT'S HISTORICAL RESULT. THE RESULT WAS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS HYB-PSA REAGENT (LOT 021026). SUBSEQUENT TESTING OF THE PATIENT'S SECOND SAMPLE ON THE SAME INSTRUMENT GENERATED A A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL HIGH RESULT WAS 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 DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1