BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2200431 · Received August 11, 2011

    Report

    Report Number
    2050012-2011-04255
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CEO
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICES GUIDED THE CUSTOMER THROUGH INSTRUMENT TROUBLESHOOTING. THE CUSTOMER PERFORMED A CUP CLEANING PROCEDURE, A LAMP CALIBRATION, AND AN INSTRUMENT CALIBRATION AND ASSAY QUALITY CONTROL ASSESSMENT. THE CUSTOMER ADVISED THAT THEY WOULD CONTACT BECKMAN COULTER IF THE TROUBLESHOOTING DID NOT RESOLVE THE CUSTOMER. NO CUSTOMER FEEDBACK REPORTS HAS BEEN RECEIVED FROM THIS CUSTOMER SINCE THE TIME OF THIS EVENT WITH A SIMILAR ISSUE. ALTHOUGH ADJUSTMENTS WERE MADE TO THE INSTRUMENT BEFORE RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 AN ERRONEOUSLY LOW PHOSPHORUS (PHOSM) RESULT WAS GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS RELEASED FROM THE LABORATORY AND THE PATIENT RECEIVED MEDICAL TREATMENT BECAUSE OF THE LOW RESULT. THE DETAILS OF PATIENT TREATMENT ARE CURRENTLY UNKNOWN. THE SAMPLE WAS RETESTED ON THE SAME INSTRUMENT, AS WELL AS ANOTHER INSTRUMENT. THE REPEAT RESULTS WERE HIGHER. NO SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. INSTRUMENT PHOSM QUALITY CONTROL RESULTS DURING THE TIMEFRAME OF THE EVENT WERE WITHIN CUSTOMER SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM CLINICAL CHEMISTRY ANALYZER CEO BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention