BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 8217442 · Received January 4, 2019

    Report

    Report Number
    2122870-2019-01043
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 15, 2018
    Report Date
    January 4, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265373
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, SEX, DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE FOUND A BENT ASPIRATE 3 PROBE AND POOR ASPIRATION ON ASPIRATE PROBE 2 DUE TO A PINCHED TUBING. HE REPLACED THE ASPIRATE PROBE 3 FROM CUSTOMER STOCK AND REPOSITION TUBING THROUGH ASPIRATE PERI PUMP ROLLERS. HE CLEANED OUT THE WASH CAROUSEL AND CHECKED ALIGNMENTS OF ASPIRATE AND DISPENSE PROBES. HE ALSO PRIMED ALL FLUIDS. INSTRUMENT WAS NOW FULLY OPERATIONAL. THE CAUSE OF THE NON-REPRODUCIBLE RESULTS WAS DETERMINED TO BE A HARDWARE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING TEN NON-REPRODUCIBLE PATIENT RESULTS ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (S/N: (B)(4)) FOR MULTIPLE ANALYTES. ONE PATIENT SAMPLE RECOVERED WITH NON-REPRODUCIBLE VITAMIN B12 (ACCESS VITAMIN B12) RESULTS. THE INITIAL SAMPLE RECOVERED AT GREATER THAN 1500 NG/L (NORMAL REFERENCE RANGE: 180-914 NG/L), WHICH WAS REPORTED OUT OF THE LABORATORY. THE CLINICIAN QUESTIONED THE RESULT; THEREFORE, THE CUSTOMER REANALYZED THE PATIENT SAMPLE ONE TIME ON THE SAME UNICEL DXI800 AND OBTAINED ACCESS VITAMIN B12 RESULT OF 394 NG/L. NO CHANGE OR IMPACT ON PATIENT TREATMENT WAS REPORTED IN CONJUNCTION WITH THIS EVENT. QUALITY CONTROL WAS REPORTED TO BE WITHIN SPECIFICATIONS AT THE TIME OF THIS EVENT. INFORMATION ON PATIENT SAMPLE COLLECTION AND PROCESSING WAS NOT PROVIDED. THERE WERE NO REPORTS OF ANY SAMPLE INTEGRITY ISSUES IN CONJUNCTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10220 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER 15099590265373

    Patients

    Seq Age Sex Outcome Treatment
    1