BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3093304 · Received May 6, 2013

    Report

    Report Number
    2122870-2013-00424
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED A VISUAL INSPECTION AND HIGH SENSITIVITY SYSTEM CHECK. THE SYSTEM CHECK FAILED DUE TO LEVEL SENSE ERROR ON REAGENT PIPETTOR #2 AND A HIGH FLIER ON REAGENT PIPETTOR #4. THE FSE DISABLED BOTH PIPETTORS (#2 AND #4) AND REPLACED BOTH REAGENT PIPETTOR TRANSDUCERS (#2 AND #4). THE ULTRASONICS WERE VERIFIED AND NECESSARY ALIGNMENTS WERE PERFORMED FOR BOTH PIPETTORS. A LEVEL SENSE WET/DRY TEST WAS PERFORMED AND PASSED WITHIN INSTRUMENT SPECIFICATIONS. QUALITY CONTROL (QC) WAS ALSO PERFORMED AND PASSED WITHIN THE LABORATORY'S ESTABLISHED RANGES. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY LOW FERRITIN RESULT, FOR ONE PATIENT, INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. AN INITIAL RESULT OF 0.3 NG/ML WAS OBTAINED AND REPORTED OUT OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REANALYZED SEVERAL TIMES AND RECOVERED RESULTS OF 76, 71, AND 79 NG/ML. THE CUSTOMER REANALYZED THE SAME SAMPLE ON AN ALTERNATE INSTRUMENT AND OBTAINED RESULTS OF 79 AND 80 NG/ML. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN 7 ML LITHIUM HEPARIN PLASMA TUBE AND CENTRIFUGED AT 3,300 RPM (ROTATIONS PER MINUTE) FOR EIGHT MINUTES, 24 HOURS AFTER COLLECTION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196428 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1