BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

    MDR report key: 2040462 · Received April 5, 2011

    Report

    Report Number
    2122870-2011-00906
    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
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE COLLECTED IN BD LIHEP PLASMA TUBES WITH A GEL SEPARATOR AND ARE CENTRIFUGED FOR TEN (10) MINUTES AT 3000 RPM. THE CUSTOMER STATED THAT THE SAMPLES ARE ANALYZED FROM THE PRIMARY CONTAINER THROUGH THE CLOSED TUBE ALIQUOTTER (CTA). PER THE CUSTOMER SUPPLIED QC CHARTS, ALL THREE LEVELS OF ACCUTNI QC HAVE BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS AFTER BEING REPEATED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THIS EVENT. THE FSE FOUND THE TUBING FOR ASPIRATE PROBE 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 CHECK VALVE ASSEMBLIES. THE FSE ALSO REPLACED THE SUBSTRATE VALVE AND PUMP DUE TO AIR BUBBLES IN THE LINE. THE FSE THEN PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK; BOTH PASSING 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 BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUT-OFF FOR FIVE (5) PATIENTS THAT WERE GENERATED BY THE UNICEL DXC 600I ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCE LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE FOR FOUR (4) PATIENTS AND A LOWER RESULT BUT STILL ABOVE THE AMI CUT-OFF ON ONE OF THE 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® IMMUNOASSAY SYSTEM. DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1