BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3191764 · Received June 26, 2013

    Report

    Report Number
    2050012-2013-00438
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUALITY CONTROL (QC) PRINTOUTS PROVIDED BY THE CUSTOMER CONFIRMS THAT QC WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT. THE CUSTOMER NOTICED A CRACK ON THE REAGENT PROBE B LEVEL SENSE BEAD. SERVICE REQUEST WAS INITIATED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 TO EVALUATE THE INSTRUMENT. THE FSE REPLACED THE REAGENT PROBE ASSEMBLY, WHICH CONTAINS THE LEVEL SENSE BEAD AND THE CARTRIDGE CHEMISTRY SAMPLE PROBE. SERVICE ALSO INSPECTED ALL REACTION WHEEL ALIGNMENTS, ALL SYRINGES, MIXER PADDLES, AND WASH STATION. FSE RECALIBRATED TBIL REAGENT, RAN SYSTEM CHECKS, AND QC. ALL RESULTS PASSED. FAILURE MODE IS HARDWARE, REPLACING THE CC SAMPLE PROBE RESOLVED THE ISSUE. THE FSE NOTICED A SLIGHT BEND IN THE PROBE, WHICH IS LIKELY TO BE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL INSTRUMENT GENERATED ERRONEOUSLY LOW TOTAL BILIRUBIN (TBIL) PATIENT RESULTS. THE CUSTOMER PROVIDED PRINTOUTS FOR TWENTY SEVEN (27) PATIENT SAMPLES; HOWEVER ONLY ELEVEN (11) PATIENTS WERE DISCREPANTLY LOW IN COMPARISON WITH THE REPEATED RESULTS GENERATED ON THE CUSTOMER'S ALTERNATE INSTRUMENT WITHIN THE LABORATORY. THE RESULTS WERE UP TO 0.8 MG/DL HIGHER UPON REPEAT ON THE CUSTOMER'S ALTERNATE INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, AMENDED REPORTS WERE ISSUED. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT SECTION OF THIS REPORT. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290471 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR