BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2192382 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02672
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON (B)(4) 2011, PRIOR TO THE ERRONEOUS RESULT. AFTER THE ERRONEOUS RESULT WAS OBTAINED, LEVELS 2 AND 3 QC WERE OUT GREATER THAN 3SD LOW, AND LEVEL 1 WAS OUT GREATER THAN 4SD HIGH. A SYSTEM CHECK PERFORMED ON (B)(4) 2011 MET SPECIFICATIONS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THE EVENT. THE FSE CLEANED AND RESEATED THE VALVE AND ROTOR ASSEMBLY, PRIMED AND PERFORMED A SYSTEM CHECK WHICH PASSED SPECIFICATIONS. QC WAS PERFORMED AND RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING A TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT'S SAMPLE. THE RESULT WAS GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 110410) AND ACCESS ACCUTNI CALIBRATOR (LOT 023153). THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. REPEAT ANALYSIS OF THE PATIENT'S SAMPLE ON AN ALTERNATE INSTRUMENT YIELDED A RESULT WITHIN THE NORMAL REFERENCE RANGE WHICH BETTER MATCHED THE PATIENT'S CLINICAL PICTURE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1