BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2040469 · Received April 5, 2011

    Report

    Report Number
    2122870-2011-00903
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN BD LITHIUM HEPARIN PLASMA TUBES WITH A GEL SEPARATOR, WHICH WERE CENTRIFUGED FOR TEN MINUTES AT 3000 RPM. THE SAMPLES WERE ANALYZED FROM THE PRIMARY CONTAINER THROUGH THE CTA (CLOSED TUBE ALIQUOTTER). ALL THREE LEVELS OF ACCUTNI QC HAD BEEN WITHIN THE ESTABLISHED RANGES. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS AFTER BEING REPEATED. SERVICE WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE FOUND THE TUBING FOR ASPIRATE PROBE #1 ROUTED OVER THE PIPETTOR MOTOR WIRE. THE FSE REPLACED ALL THREE ASPIRATE PROBES AND THE ASSOCIATED PERI-PUMP TUBING. THE FSE FLUSHED THE VACUUM PUMP AND CHECKED VALVE ASSEMBLIES. THE FSE REPLACED THE SUBSTRATE VALVE AND PUMP DUE TO AIR BUBBLES IN THE LINE. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK. BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BY BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED CKMB RESULTS, ABOVE THE NORMAL REFERENCE RANGE, GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR BOTH PATIENTS. 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® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1