BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2942748 · Received February 4, 2013

    Report

    Report Number
    2122870-2013-00083
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S BIOMEDICAL ENGINEER OBSERVED ASPIRATE PROBE #3 WAS OBSTRUCTED, CAUSING A FLOOD IN THE WASH CAROUSEL. THE ENGINEER REPLACED THE ASPIRATE PROBES, PERISTALTIC PUMP TUBING, ALL MIXER COMPONENTS, AND THE SUBSTRATE PROBE TO RESOLVE THE ISSUE. THE LIKELY CAUSE OF THIS EVENT WAS THE OBSTRUCTION OF ASPIRATE PROBE #3. THE INSTRUMENT WAS IN OPERATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00081, 2122870-2013-00082, 2122870-2013-00083.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS PROGESTERONE, THYROID-STIMULATING HORMONE (TSH), TROPONIN I (ACCESS ACCUTNI), TOTAL BETA HUMAN CHORIONIC GONADOTROPHIN 2 (TBHCG2), FREE THYROXINE (FRT4), CREATINE KINASE-MB (CK-MB), MYOGLOBIN, AND B-TYPE NATRIURETIC PEPTIDE (BNP) 2 RESULTS, FOR 50 PATIENTS, ON SEPARATE SHIFTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER ALSO NOTED MAIN PIPETTOR DETECTED OBSTRUCTION AND SAMPLE COUNTS OUTSIDE LIMITS SYSTEM ERRORS. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND 33 AMENDED REPORTS WERE ISSUED TO THE HOSPITAL. THE CUSTOMER STATED ONE PATIENT WAS SENT BACK FOR ADDITIONAL THYROID TESTING. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS EVENT. QUALITY CONTROL (QC), FOR ALL ASSAYS, WAS WITHIN SPECIFICATION AT THE TIME OF THE EVENT. THE CUSTOMER'S BIOMEDICAL ENGINEER ASSESSED THE INSTRUMENT AT THE FACILITY. THIS IS REPORT THREE OF THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47452 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1