BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3061271 · Received April 16, 2013

    Report

    Report Number
    2122870-2013-00348
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABORATORY DECLINED TO PROVIDE SAMPLE HANDLING INFORMATION. THE CUSTOMER DID NOT REPORT ANY SAMPLE QUALITY ISSUES. THE CUSTOMER STATED QC IS CURRENTLY PERFORMING WITHIN THE LABORATORY'S ESTABLISHED LIMITS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE PERFORMED A SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK, AND BOTH PASSED WITHIN SPECIFICATIONS. THE FSE VERIFIED THAT QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMERS ESTABLISHED LIMITS. THE FSE VERIFIED THAT THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO HARDWARE ISSUES WERE IDENTIFIED. A CAUSE FOR THIS EVENT COULD NOT BE DETERMINED WITH THE INFORMATION SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, (BEC) TO REPORT THAT THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM GENERATED ONE ERRONEOUS TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULT ON A PATIENT SAMPLE. THE INITIAL TBHCG RESULT OF >1000 MIU/ML WAS FLAGGED OVR, INDICATING THE CALCULATED CONCENTRATION WAS ABOVE THE HIGHEST OR MOST CONCENTRATED CALIBRATOR. THE CUSTOMER REPEATED THE SAMPLE (ON THE DIL-HCG ASSAY) AND RECEIVED A RESULT OF < 1000 MIU/ML. THE CUSTOMER REPEATED THE SAMPLE AGAIN AND RECEIVED A RESULT OF 3.00 MIU/ML. THE CUSTOMER ALSO RAN THE SAMPLE ON ANOTHER INSTRUMENT (ACCESS 2) AND RECEIVED RESULTS OF 2 AND 3 MIU/ML. THE CUSTOMER WAS QUESTIONING THE INITIAL OVR-FLAGGED RESULT. THE CUSTOMER STATED NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT REPORT AN EFFECT TO PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT. NO EVENT LOG MESSAGES WERE GENERATED IN CONNECTION WITH THIS EVENT. NO OTHER ASSAYS OR PATIENT RESULTS WERE IN QUESTION. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS BEFORE AND AFTER THE EVENT. QC DATA IN THE MONTH PRIOR TO THE EVENT INDICATED MULTIPLE DAYS WHERE QC LEVEL 3 WAS OUTSIDE LIMITS. HOWEVER, REVIEW OF THE QC DATA INDICATED THE LABORATORY HAS THE QC LEVEL 3 RANGE SET TIGHTER THAN PEER DATA OR ACTUAL PERFORMANCE DATA WOULD SUGGEST WAS REASONABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162781 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1