BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU680 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1843206 · Received September 24, 2010

    Report

    Report Number
    2050012-2010-00828
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PCB VERSION 6 WAS REPLACED ON (B)(4) 2010 WITH PCB VERSION 5 AND THE SYSTEM HAS WORKED PROPERLY FOR 2 DAYS. INVESTIGATION IS ON-GOING AND A BCI SPECIALIST IS WORKING WITH THE ACCOUNT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEVEL SENSE DETECTION PROBLEM ON THE AU 680 CLINICAL CHEMISTRY ANALYZER WHICH WAS LEADING TO ZERO RESULTS WITH A G FLAG. NO PATIENTS WERE IMPACTED. THE LIS SYSTEM DOES NOT VALIDATE THESE RESULTS AND THEY ARE REPEATED AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU680 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1