BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2843136 · Received November 21, 2012

    Report

    Report Number
    2050012-2012-01848
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE CARTRIDGE CHEMISTRY (CC) SYRINGE DRIVE. THE FSE DISCOVERED 2 SCREWS HOLDING THE SYRINGE PLUNGER HAD BECOME LOOSE AND 1 HAD FALLEN OUT. THE FSE RE-INSTALLED THE SCREW, TIGHTENED BOTH SCREWS AND RESOLVED THE ISSUE. SERVICE ACTIVITY WAS VERIFIED PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER-SUPPLIED DATA INDICATES A THIRD PATIENT'S ORIGINAL RESULT; IT IS UNKNOWN IF THE RESULT WAS ERRONEOUS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE LOW HAPTOGLOBIN (HPT) AND FALSE HIGH DIGOXIN (DIGN) RESULTS ON TWO SEPARATE PATIENTS INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. PATIENT #1 OBTAINED AN HPT RESULT OF 191 MG/DL WITH A REPEATED RESULT OF 242 MG/DL. PATIENT #2 OBTAINED A DIGN RESULT OF 2.5 NG/ML AND A REPEATED RESULT OF 1.1 NG/ML. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QUALITY CONTROL (QC) WAS ANALYZED ELEVEN HOURS PRIOR TO THE EVENT AND DIGN AND HPT WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES. AFTER THE EVENT, DIGN WAS ELEVATED, AT > 4 STANDARD DEVIATION AND HPT WAS LOW, AT > 4 STANDARD DEVIATION. THE CUSTOMER INDICATED QUALITY CONTROL (QC) FROM OTHER ANALYTES WAS ALSO OUT OF RANGE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1