BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2704982 · Received August 17, 2012

    Report

    Report Number
    2122870-2012-01682
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Date of Event
    July 23, 2012
    Report Date
    July 23, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    OEW
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THEY HAD DECREASED PARATHYROID HORMONE (PTH) QUALITY CONTROL RECOVERY ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (DXI 600 ANALYZER) WITH SERIAL NUMBER (B)(4). BEC CUSTOMER TECHNICAL SUPPORT (CTS) TROUBLESHOT THE ISSUE WITH THE CUSTOMER VIA THE TELEPHONE. CTS DETERMINED THAT THE REAGENT PACK WAS REMOVED FROM THE LABORATORY'S OTHER ANALYZER (SERIAL NUMBER (B)(4)) AFTER BEING USED FOR INTRAOPERATIVE INTACT PARATHYROID HORMONE AND THEN PLACED ON THE DXI 600 ANALYZER (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT THEY USED PTH REAGENT PACK, LOT 122078, ON THE DXI 600 ANALYZER (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT THE PTH REAGENT LOT 122078 WAS CALIBRATED USING PTH CALIBRATOR LOT 289723. CUSTOMER INDICATED THAT THEY WERE USING BIORAD QUALITY CONTROL MATERIAL, LOT 41650, LEVELS 1, 2, AND 3 AS QUALITY CONTROL. CUSTOMER REPORTED THAT 9 PATIENT SAMPLES WERE ANALYZED USING REAGENT PACK LOT 122078. CUSTOMER REPORTED THAT THE RESULTS WERE RELEASED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THEY WERE UNABLE TO REPEAT THE SAMPLES BECAUSE THE SAMPLES WERE STORED BEYOND THE ACCEPTABLE TIME TO PERFORM THE PTH ASSAY. CUSTOMER DID NOT PROVIDE ANY PATIENT DATA. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CTS ADVISED THE CUSTOMER TO REMOVE AND DISCARD PTH REAGENT PACK LOT 122078 AND LOAD A NEW REAGENT PACK USING PROPER TECHNIQUE. BEC ALSO ANALYZED THE DXI 600 ANALYZER (SERIAL NUMBER (B)(4)) EVENT LOG. THE EVENT LOG INDICATED THAT THE DXI 600 ANALYZER DISPLAYED TWO (2) "REAGENT PACK MONITORING ERRORS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE OEW BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1