BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3031781 · Received April 2, 2013

    Report

    Report Number
    2050012-2013-00242
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. THERE IS NO INDICATION THAT QC WAS RUN AFTER THE EVENT, PRIOR TO TROUBLESHOOTING. BEC CUSTOMER TECHNICAL SUPPORT (CTS) WORKED WITH THE CUSTOMER AND DISCOVERED THAT ONE OF THE FITTINGS ON THE 3 WAY VALVE (OF THE SAMPLE SYRINGE) WAS LOOSE. IT IS UNKNOWN HOW THE FITTING BECAME LOOSE. THE CUSTOMER TIGHTENED THE FITTING AND RESOLVED THE ISSUE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER CORRECTED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER GENERATED FALSE HIGH SODIUM (NA) AND CARBON DIOXIDE (CO2) RESULTS FOR TWO (2) PATIENT SAMPLES. THE ERRONEOUSLY HIGH RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RERUN AND YIELDED RESULTS WITHIN THE NORMAL REFERENCE RANGE, WHICH WERE REPORTED OUT. IT IS UNKNOWN WHETHER THE SAMPLES WERE RERUN ON THE ORIGINAL OR AN ALTERNATE INSTRUMENT. THE CUSTOMER PROVIDED THE RESULTS VERBALLY SO NO RAW PATIENT DATA WAS PROVIDED (PATIENT DEMOGRAPHIC INFORMATION NOT SUPPLIED). THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134208 UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1