BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL¿ DXL800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2358992 · Received December 5, 2011

    Report

    Report Number
    2122870-2011-06033
    Event Type
    Malfunction
    Date Received
    December 5, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FSE PERFORMED A CARRY OVER TEST WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE INSTRUMENT PERFORMED AS EXPECTED. ALTHOUGH ALL THE ERRONEOUS TEST RESULTS WERE OBTAINED FROM A SINGLE REAGENT PACK, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 HIGHER THAN EXPECTED GI MONITOR RESULTS WERE GENERATED ON A UNICEL DXI800 ACCESS IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENT SAMPLES. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA REVEALED EIGHT INITIAL GI MONITOR RESULTS WHICH WERE INITIALLY WITHIN OR ABOVE THE ASSAY'S NORMAL REFERENCE INTERVAL. THE INITIAL GI MONITOR PATIENT RESULTS WERE ALL ASSOCIATED WITH AS SINGLE GI MONITOR REAGENT PACK. UPON REPEAT TESTING, UTILIZING DIFFERENT REAGENT PACKS, LOWER GI MONITOR RESULTS, EITHER WITHIN OR ABOVE THE ASSAY'S REFERENCE INTERVAL, WERE GENERATED. THE INITIAL, SUSPECT GI MONITOR RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY HOWEVER THERE WERE NO REPORTS OF DEATHS, SERIOUS INJURIES OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA ALSO REVEALED TWO PATIENT'S GI MONITOR RESULTS WHICH WERE WITHIN THE EXPECTED PRECISION OF THE ASSAY AND/OR DID NOT POSSESS CONFIRMATORY REPEAT RESULTS. THESE RESULTS WERE NOT QUESTIONED BY THE CUSTOMER AS ERRONEOUS AND WERE THEREFORE NOT INCLUDED AS PART OF THIS EVENT. THE CUSTOMER INDICATED THAT THE INSTRUMENT ASSAY QUALITY CONTROL (QC) RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT, WITH THE EXCEPTION OF THOSE QC RESULTS LINKED TO THE INVOLVED REAGENT PACK. AN INSTRUMENT ROUTINE SYSTEM CHECK PERFORMED DURING THE TIMEFRAME OF THIS EVENT MET INSTRUMENT SPECIFICATIONS. NO SPECIFIC PATIENT DATA OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL¿ DXL800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS GI MONITOR REAGENT