BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2855194 · Received December 3, 2012

    Report

    Report Number
    2122870-2012-01944
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN SERUM SEPARATOR TUBES AND CENTRIFUGED FOR 10 MINUTES AT 3000 RPM. SYSTEM CHECKS WERE PASSING WITHIN SPECIFICATIONS PRIOR TO THE EVENT. QC WAS ALSO PASSING WITHIN THE CUSTOMER'S RANGES THE DAY OF THE EVENT; BHCG QC HAD SHIFTED HIGH, BUT WAS STILL IN RANGE. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE A DAY AFTER THE EVENT. FSE REPLACED THE INSTRUMENT INCUBATOR BELT, WASH PUMP SEALS AND WASH PUMP BELT AND REBUILT THE WASH PUMP. FSE OBSERVED HIGH SENSITIVITY CHECK FAILURES AFTER THE INITIAL REPAIRS SO THE FSE ORDERED ADDITIONAL PARTS FOR CONTINUED REPAIRS. FSE RETURNED TO THE CUSTOMER SITE ON (B)(4) 2012, AND REPLACED MIXER PULLEYS, MIXER BELT, ASPIRATE PROBES, ASPIRATE PROBE TUBING, DISPENSE PROBES, AND THE WASH PUMP STATOR. FSE WAS THEN ABLE TO COMPLETE A SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK, AND QC, WHICH PASSED WITHIN SPECIFICATIONS. IN CONCLUSION, HARDWARE IS THE LIKELY CAUSE OF THIS EVENT. SEVERAL PARTS WERE REPLACED BY THE FSE AND A SPECIFIC HARDWARE MALFUNCTION COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING ERRONEOUSLY ELEVATED ACCUTNI PATIENT RESULTS WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY GENERATED BY THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENTS. REPEAT TESTING OF THE PATIENT SAMPLES ON THEIR ALTERNATE ANALYZER PRODUCED LOWER RESULTS WITHIN THE NORMAL RANGE OF THE ASSAY. THE CUSTOMER ALSO REPORTED BHCG COMPARISON STUDY ISSUES ON THEIR DXC 600I INSTRUMENT AFTER BHCG QC HAD SHIFTED OUT OF RANGE HIGH ON THE INSTRUMENT A DAY AFTER THE EVENT. THE CUSTOMER INDICATED THERE WERE NO CHANGES IN PATIENT TREATMENT OR AFFECT TO ANY PATIENT IN CONNECTION TO 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 MMI BECKMAN COULTER INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1