BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2196079 · Received August 9, 2011

    Report

    Report Number
    2122870-2011-02805
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE PLASMA. CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. PER THE CUSTOMER COMPLAINT RECORDS, TBHCG QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE ERRONEOUS RESULTS. SAMPLES WERE SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER INVESTIGATION. CPLS WAS UNABLE NOT REPRODUCE THE CUSTOMER RESULTS FOR SAMPLE 1/1. CPLS STATED THAT IF THE INSTRUMENT IS OPERATIONAL, THEN PRE-ANALYTICAL SAMPLE HANDLING/COLLECTION IS THE PROBABLE ROOT CAUSE FOR THIS EVENT. THE INVESTIGATION DID NOT DEMONSTRATE A REAGENT RELATED ISSUE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING HIGHER THAN EXPECTED TOTAL BETA - HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULTS ON ONE (1) PATIENT'S SAMPLE, GENERATED BY THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. UPON REPEAT THE RESULT WAS LOWER AND OUTSIDE THE ASSAYS PRECISION CLAIMS. 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 600 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE DHA BECKMAN COULTER INC. DXI 600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR