BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2213699 · Received August 17, 2011

    Report

    Report Number
    2050012-2011-04483
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FSE FOUND A LOOSE SAMPLE PROBE AND THAT ONE OF THE CUVETTE WIPERS WAS NOT ALIGNED. THIS WAS REGARDED AS THE ROOT CAUSE OF THIS EVENT. THE INSTRUMENT WAS SUBSEQUENTLY REPAIRED AND RETURNED BACK INTO SERVICE. ASSOCIATED MDR FOR THIS EVENT: 2050012-2011-04481, 2050012-2011-04483.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY LOW OR SUPPRESSED CREATININE (CR-S), BLOOD UREA NITROGEN (BUN) AND ASPARTATE AMINOTRANSFERASE (AST) RESULTS WERE GENERATED ON A UNICEL DXC 600 SYNCHRON SYSTEM FOR MULTIPLE PATIENTS OVER TWO DAYS. THIS IS REPORT TWO OF TWO AND REPRESENTS THE ERRONEOUS AND SUPPRESSED RESULTS GENERATED FROM THE UNICEL DXC 600 SYNCHRON SYSTEM ON (B)(6) 2011. DATA PROVIDED BY THE CUSTOMER INDICATED THAT THREE INITIAL LOW CR-S RESULTS WERE GENERATED FOR THREE PATIENTS. DATA PROVIDED BY THE CUSTOMER INDICATED THAT AST RESULTS WERE NOT ERRONEOUS RESULTS, BUT WERE APPROPRIATELY SUPPRESSED AND ERROR FLAGGED BY THE SYSTEM. THE ERRONEOUS INITIAL RESULTS AND SUPPRESSED RESULTS WERE CAUSED BY A SINGLE MALFUNCTION. ONCE CORRECTED, REPEAT RESULTS GENERATED FROM THE SAME INSTRUMENT WERE HIGHER AND CONSIDERED VALID. TWO ERRONEOUS INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND REQUIRED A CORRECTIVE REPORT. THE OTHER ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN AS TO WHICH RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WERE NO DEATHS, SERIOUS INJURIES OR CHANGES TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT ASSAY QUALITY CONTROL RESULTS GENERATED IMMEDIATELY PRIOR TO THE EVENT WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS. SAMPLES WERE COLLECTED IN PRIMARY TUBES WHICH WERE A COMBINATION OF GREEN AND TIGER TOP TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1