BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2548618 · Received April 25, 2012

    Report

    Report Number
    2122870-2012-01172
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT AS THE CUSTOMER DECLINED SERVICE. WHILE TROUBLESHOOTING THE ISSUE THE CUSTOMER NOTED THAT THE SUBSTRATE TUBING FITTINGS TO THE SUBSTRATE BOTTLE CAP TO BE LOOSE. ONCE TIGHTENED, THIS RESOLVED THE CUSTOMER'S ISSUE THE CAUSE FOR THIS EVENT IS LOOSE SUBSTRATE TUBING FITTINGS TO THE SUBSTRATE BOTTLE CAP, RESULTING IN INTERMITTENT FAILURE OF SUBSTRATE DELIVERY. ASSOCIATED MDRS: 2122870-2012-01170, 2122870-2012-01171, 2122870-2012-01172, 2122870-2012-01173, 2122870-2012-01174, 2122870-2012-01175.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CARDIAC TROPONIN (ACCUTNI) NO VALUE RESULTS WITH INSTRUMENT FLAGS WERE GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR EIGHT PATIENTS ACROSS MULTIPLE SHIFTS AND MULTIPLE DAYS. THIS REPORT REPRESENTS THE CARDIAC TROPONIN (ACCUTNI) NO VALUE RESULT WITH AN INSTRUMENT FLAG WHICH WAS GENERATED ON (B)(6) 2012. THE INSTRUMENT FLAG WAS AN INDETERMINATE FLAG WHICH WAS INDICATIVE OF A RESULT THAT CANNOT BE DISTINGUISHED FROM A SYSTEM FAILURE BECAUSE THE RELATIVE LIGHT UNIT READING OR CONCENTRATION IS TOO LOW OR TOO LOW. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT UPON MULTIPLE REPEAT TESTING ON THE SAME INSTRUMENT, ANOTHER NO VALUE RESULT WAS GENERATED, FOLLOWED BY THE GENERATION OF A NUMERIC RESULT WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY WHICH WAS REGARDED AS VALID. NO OTHER RESULTS FROM THIS PATIENT WERE IN QUESTION IN CONNECTION WITH THIS EVENT. PACK SHARING WAS CONFIRMED AS NO OCCURRING. THE INITIAL ACCUTNI NO VALUE RESULT WAS RELEASED FROM THE LABORATORY HOWEVER THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER UTILIZED PLASMA SEPARATOR TUBES FOR ACCUTNI SAMPLE COLLECTION. THE CUSTOMER INDICATED ACCUTNI QUALITY CONTROL (QC) SAMPLES RUN BEFORE THE INCIDENT WERE WITHIN THE CUSTOMER¿S ESTABLISHED LIMITS. THE CUSTOMER DID NOT PROVIDE QC DATA FROM AFTER THE INCIDENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT ALL SYSTEM CHECK PARAMETERS PRIOR TO THE EVENT PASSED WITHIN SPECIFICATIONS. HOWEVER, THE SYSTEM CHECK PERFORMED AFTER THE EVENT FAILED TO MEET SPECIFICATIONS WITH INDICATION OF THE POSSIBILITY OF CONTAMINATED SUBSTRATE. NO EVENT LOG MESSAGES WERE GENERATED IN CONNECTION WITH THIS EVENT. ADDITIONALLY, AFTER THE EVENT, THE CUSTOMER INDICATED THAT THERE WERE MULTIPLE FAILING CALIBRATIONS OF TOTAL HUMAN CHORIONIC GONADOTROPIN (TBHCG). THE ACCUTNI REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 122054 AND 116461 RESPECTIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR