BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM

    MDR report key: 2212366 · Received August 15, 2011

    Report

    Report Number
    2122870-2011-02947
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAS NOT BEEN PROVIDED. GI MONITOR QC IS CURRENTLY RESULTING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. ADDITIONAL SYSTEM INFORMATION HAS NOT BEEN SUPPLIED TO DATE. ON (B)(6) 2011 A BEC FIELD SERVICE ENGINEER (FSE) PERFORMED A PM ON THE INSTRUMENT. FSE REPLACED THE TUBING FOR ALL FOUR REAGENT PIPETTORS AND THE TRANSDUCERS FRO REAGENT PIPETTOR#1 AND #4. FSE REPLACED THE PRECISION PUMP PISTON AND SEAL FOR REAGENT PIPETTOR#3. ALTHOUGH HARDWARE MAY HAVE BEEN A CONTRIBUTING FACTOR, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO INCONSISTENT GI MONITOR RESULTS FOR TWO PATIENTS, AS WELL AS QC FAILURE GENERATED BY THE UNICEL DXI800 ACCESS IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE INITIAL SAMPLES WERE REPEATED ON THE SAME UNIT AND INCONSISTENT RESULTS PERSISTED. THE CUSTOMER DID PROVIDE ONE EXAMPLE OF QC FAILURE; FIRST REPLICATE RESULTED AS 108 U/ML AND THE SECOND REPLICATE RESULTED AS 60.78 U/ML. THE TARGET FOR THE QC WAS 62.2 U/ML. HOWEVER, IT IS UNKNOWN ON WHICH LEVEL OF QC THIS WAS FOR AND ON WHICH DATE THESE RESULTS WERE OBTAINED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1