BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2465944 · Received February 23, 2012

    Report

    Report Number
    2050012-2012-00555
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS THE ISSUE WAS RESOLVED VIA BECKMAN COULTER INC. LED CUSTOMER TROUBLESHOOTING. BECKMAN COULTER INC, CUSTOMER TECHNICAL SUPPORT (CTS) HAD THE CUSTOMER PERFORM ROUTINE TROUBLESHOOTING INCLUDING CHECKING THE CARTRIDGE CHEMISTRY (CC) SAMPLE SYRINGE AND CC SAMPLE PROBE, CC REAGENT SYRINGE AND PROBES FOR SIGN OF LEAKS, BENT, BUBBLES, OR LOOSE CONNECTIONS. CTS SUGGESTED FLUSHING AND CLEANING THE CC SAMPLE PROBE. THE CUSTOMER INDICATED THAT THEY PERFORMED THE CLEANING PROCEDURES AND RAN QUALITY CONTROL ASSESSMENTS WHICH APPEARED TO BE WITHIN RANGES. ROOT CAUSE IS NOT KNOWN, BUT THE ISSUE WAS RESOLVED VIA HARDWARE MAINTENANCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY LOW CREATININE (CR-S), GLUCOSE (GLU), AND BLOOD UREA NITROGEN (BUN) RESULTS WERE GENERATED ON A UNICEL DXC 600 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. BECKMAN COULTER INC. REVIEW OF CUSTOMER SUPPLIED PATIENT DATA INDICATED THAT INITIAL, DISCREPANT TOTAL PROTEIN (TP), ALBUMIN (ALB), TOTAL BILIRUBIN (TBIL), AND ALKALINE PHOSPHOTASE (ALP) RESULTS WERE ALSO GENERATED FOR THIS PATIENT. UPON REPEAT ON THE SAME INSTRUMENT, THE PATIENT CHEMISTRY RESULTS WERE HIGHER AND REGARDED AS VALID. THE ERRONEOUS INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND HENCE NO DEATHS, SERIOUS INJURIES OR CHANGES TO PATIENT TREATMENT WERE ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT LEVEL TWO, QUALITY CONTROL RESULTS WERE LOW AFTER THE GENERATION OF THE INITIAL SAMPLE RESULTS. NO OTHER CHEMISTRY PATIENT RESULTS WERE IMPACTED BY THIS EVENT. THE SAMPLE WAS NORMAL IN APPEARANCE WITH NO EVIDENCE OF FIBRIN.

    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 59 YR