BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3200741 · Received July 1, 2013

    Report

    Report Number
    2122870-2013-00584
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED A FAILING DILUTION TEST AND DETERMINED POSSIBLY FAULTY PRECISION PUMP. THE FSE REBUILT THE PRECISION PUMP AND VERIFIED PIPETTE ALIGNMENTS, ULTRASONIC SETTINGS, AND MIXER SPEEDS. THE FSE REPEATED THE DILUTION TEST WITH PASSING RESULTS AND PERFORMED TESTING OF THE ELEVATED PATIENT SAMPLE AND GENERATED DIL-BHCG RESULTS THAT MATCHED THE DIL-BHCG RESULTS FROM THE ALTERNATE SECOND ACCESS INSTRUMENT AND RESULTS FROM MANUALLY DILUTED SAMPLES. THE FSE PERFORMED PASSING QUALITY CONTROL (QC) TO VERIFY INSTRUMENT PERFORMANCE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SUPPRESSED DIL- BETA HUMAN CHORIONIC GONADOTROPHIN (BHCG) RESULTS (<1,000M IU/ML) FOR ONE PATIENT SAMPLE AND SEVERAL SURVEY SAMPLE RESULTS INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. REPEAT DIL-BHCG TESTING OF THE SAMPLES, ON AN ALTERNATE ACCESS INSTRUMENT, PRODUCED EXPECTED RESULTS THAT WERE GREATER THAN 1,000 MIU/ML AND CORRELATED WITH THE ORIGINAL BHCG RESULTS (>1,000 MIU/ML). THE CUSTOMER STATED THE ERRONEOUSLY SUPPRESSED DIL-BHCG PATIENT RESULT OF <1,000 MIU/ML WAS NOT RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION AT THE TIME OF THE EVENT. SYSTEM CHECK, PERFORMED ON THE DAY OF THE EVENT, PASSED WITHIN SPECIFICATIONS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297759 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1