BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2258751 · Received September 22, 2011

    Report

    Report Number
    2122870-2011-03999
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE PATIENT SAMPLES WERE COLLECTED IN "ORANGE TOP" AND "GREEN TOP" SAMPLE TUBES. ADDITIONAL COLLECTION DEVICE AND SAMPLE CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. QC WAS PERFORMING WITHIN THE CUSTOMERS ESTABLISHED RANGES AT THE TIME OF THE EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 08/23/2011 FOR THIS EVENT. THE FSE DISCOVERED THAT THE DISPENSE PROBE #1 HAD BEEN BENT SO THE FSE REPLACED THE PROBE. THE FSE ALSO REMOVED AND CLEANED THE WASH WHEEL DUE TO DRIED WASH BUFFER RESIDUE WITHIN THE CAROUSEL. THE FSE CHECKED INSTRUMENT ALIGNMENTS AND THE CUSTOMER PERFORMED QC WHICH RESULTED WITHIN THEIR ESTABLISHED RANGES TO VERIFY HARDWARE OPERATION. THE FSE PERFORMED A PASSING SYSTEM CHECK AND PASSING HIGH SENSITIVITY SYSTEM CHECK AND BOTH RESULTED WITHIN INSTRUMENT SPECIFICATIONS AFTER REPAIRS HAD BEEN COMPLETED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED BETA - HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. REPEAT TESTING OF THE PATIENT SAMPLE PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WERE NO REPORTS 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1