BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2242271 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05210
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS BECKMAN COULTER INC. LED TROUBLESHOOTING APPEARED TO HAVE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MULTIPLE ERRONEOUS CHEMISTRY CARTRIDGE ASSAY ERRONEOUS RESULTS WERE GENERATED ON A SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM. THE NUMBER OF PATIENTS, DATES OF OCCURRENCE, CHEMISTRIES INVOLVED AND ACTUAL PATIENT RESULTS ARE UNKNOWN. BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICES GUIDED THE CUSTOMER THROUGH INSTRUMENT TROUBLESHOOTING WHICH INVOLVED FLUSHING OF THE CHEMISTRY CARTRIDGE PROBE. THE CUSTOMER INDICATED THAT DURING FLUSHING THEY FELT THAT THEY HAD DISLODGED A PROBE RESTRICTION. BECKMAN COULTER INC. CUSTOMER TECHNICAL SERVICES ADVISED THE CUSTOMER TO RECALIBRATE THE INSTRUMENT ASSAYS AND REPEAT ANY SUSPECT PATIENT RESULTS. UPON BECKMAN COULTER INC. FOLLOW-UP, THE CUSTOMER INDICATED THAT THREE PATIENT RESULTS POSSESSED CHEMISTRY RESULTS THAT WERE IDENTIFIED AS ERRONEOUS UPON REPEAT TESTING AFTER TROUBLESHOOTING. BECKMAN COULTER INC. ASSESSMENT OF PATIENT SUPPLIED DATA INDICATED THAT TOTAL BILIRUBIN (TBIL), DIRECT BILIRUBIN (DBIL), ALKALINE PHOSPHOTASE (ALP), CHOLESTEROL (CHOL) AND/OR ALANINE TRANSAMINASE (ALT) ERRONEOUS INITIAL PATIENT RESULTS WERE GENERATED ON A SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM FOR THREE PATIENTS ON (B)(6) 2011. THIS REPORT REPRESENTS THESE ERRONEOUS RESULTS. UPON REPEAT ON THE SAME INSTRUMENT, THE CHEMISTRY RESULTS RECOVERED HIGHER AND WERE CONSIDERED VALID. AMENDED REPORTS WERE ISSUED. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. NO PATIENT SPECIFIC INFORMATION, SAMPLE HANDLING/COLLECTION INFORMATION OR INSTRUMENT SYSTEM INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1