BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2385311 · Received December 21, 2011

    Report

    Report Number
    2050012-2011-08453
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    November 26, 2011
    Report Date
    November 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT SOME CHEMISTRIES ON THE CARTRIDGE CHEMISTRY (CC) SIDE OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM HAVE ERRATIC QUALITY CONTROL ISSUES, NAMELY AMMONIA (AMM), LACTATE (LACT) AND TOTAL PROTEIN (TPM). CUSTOMER REPORTED THAT CALIBRATION FAILED AND THEY RECALIBRATED THE CHEMISTRIES. CUSTOMER REPORTED THAT THE DXC 600I GENERATED BLANK ABSORBANCE LOW (BLK ABS LOW) AND OUT OF INSTRUMENT RANGE LOW (OIR LOW) ERRORS FOR AMM, ETHANOL (ETOH) AND TPM AFTER THE RECALIBRATION. CUSTOMER REPORTED THAT THE TOTAL BILIRUBIN (TBIL) AND DIRECT BILIRUBIN (DBIL) QUALITY CONTROL RESULTS WERE ERRATIC AFTER RECALIBRATION. CUSTOMER REPORTED THAT FLUID HAS SEEN DRIPPING FROM REAGENT PROBE B. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE SLIGHTLY BENT REAGENT MIXER PADDLE. THE FSE PERFORMED WASH STATION DEFLECTION ALIGNMENT AND ALL PROBE ALIGNMENTS. THE FSE REPLACED THE CC SAMPLE PROBE. THE FSE RAN PRECISION VERIFICATION TEST FIVE TIMES AND NOTED NORMAL PRECISION. THE FSE RAN QUALITY CONTROL AND VERIFIED OPERATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1