BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS CEA

    MDR report key: 5093818 · Received September 22, 2015

    Report

    Report Number
    2122870-2015-00597
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHX
    PMA / PMN Number
    K031270
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, AND WEIGHT. (B)(6). A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE PERFORMED PRESSURE SENSOR CALIBRATION; NO HARDWARE MALFUNCTIONS WERE IDENTIFIED THAT MAY HAVE CAUSED, OR CONTRIBUTED, TO THIS EVENT. THE IMPLICATED REAGENT PACKS WERE DISCARDED BY THE CUSTOMER AND ARE NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION OF THE EVENT DETERMINED THAT AN ERROR OCCURRED ON THE MANUFACTURER'S REAGENT PACK FILL LINE. DUE TO THE ERROR, PARTIALLY FILLED REAGENT PACKS WERE RELEASED FOR USE. WHEN USED TO ANALYZE PATIENT SAMPLES, PARTIALLY FILLED REAGENT PACKS COULD CAUSE NO VALUE/QSD-FLAGGED RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING TWO (2) NO VALUE/QSD-FLAGGED (INSUFFICIENT SAMPLE OR REAGENT VOLUME DISPENSED) CARCINOEMBRYONIC ANTIGEN (ACCESS CEA) PATIENT RESULTS ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, SERIAL NUMBER (B)(4). THE CUSTOMER DID NOT INDICATE IF THESE SAMPLES WERE REANALYZED AND WHAT RESULTS THEY OBTAINED IF REANALYSIS DID OCCUR. UPON VISUAL INSPECTION, THERE WERE NO SIGNS OF REAGENT PACK LEAKAGE. NONE OF THE QSD-FLAGGED ACCESS CEA RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. CALIBRATION AND QUALITY CONTROL (QC) DATA WERE NOT PROVIDED FOR THIS EVENT. THE CUSTOMER DID NOT PROVIDE SPECIFIC DETAILS REGARDING THE PATIENT SAMPLES OR SAMPLE PROCESSING. THERE WAS NO INDICATION OF SAMPLE INTEGRITY ISSUES RELATED TO THIS EVENT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626695 ACCESS CEA SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN, PRODUCT CODE: DHX DHX BECKMAN COULTER NA 595027

    Patients

    Seq Age Sex Outcome Treatment
    1