BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXI (CLSI) CONNECTION, POWER EXPRESS

    MDR report key: 8162788 · Received December 13, 2018

    Report

    Report Number
    2050012-2018-01042
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 14, 2018
    Report Date
    December 13, 2018
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDD
    UDI-DI
    15099590673444
    PMA / PMN Number
    K140496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER COMPLAINT HANDLING UNIT EVALUATED THE ISSUE WITH THE POWER EXPRESS. THE POWER EXPRESS NEEDS A SERIAL CONNECTION FROM INSTRUMENTS AND IN THIS CASE THERE WAS A TRIPLE CONNECTION FROM THE ACCESS IMMUNOASSAY DXI SYSTEM. THE FAILURE MODE WAS IDENTIFIED AS AN ERROR IN THE CONNECTION OF THE CABLES WHEN THE COMMUNICATIONS MODULE WAS CHANGED. THE CONNECTION OF THE CABLES WAS CORRECTED TO RESOLVE THE ISSUE. (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING MULTIPLE ERRONEOUS PATIENT RESULTS ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED SEVERAL ERRONEOUS RESULTS ON MULTIPLE ASSAYS INCLUDING VITAMIN B12. DUE TO AN ERROR IN THE CONNECTION OF 2 DXI TO PEX (POWER EXPRESS), THE RESULTS OBTAINED BY THESE ANALYZERS ON (B)(6) 2018 WERE ERRONEOUSLY ASSIGNED TO A WRONG ID (IDENTIFICATION). ONLY SAMPLES PROCESSED BY PEX WERE AFFECTED. THE CUSTOMER IDENTIFIED 136 SAMPLES THAT WERE AFFECTED WITH DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000287 DXI (CLSI) CONNECTION, POWER EXPRESS RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER DXI (CLSI) CONNECTION, POWER EXPRESS 15099590673444

    Patients

    Seq Age Sex Outcome Treatment
    1