BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

    MDR report key: 2120756 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01791
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A SERUM SAMPLE TUBE AND CENTRIFUGED AT 3062 RPM FOR 10 MINUTES. ALL PATIENT SAMPLES ARE LOADED THROUGH THE CLOSED TUBE ALIQUOTTER (CTA). . PER THE CUSTOMER, QC HAD BEEN PERFORMING WITHIN THE CUSTOMERS ESTABLISHED RANGES PRIOR TO THE EVENT. ON THE DAY OF THE EVENT, LEVEL 1 QC RESULTS WERE OUT OF RANGE. SYSTEM CHECK DATA SUPPLIED FROM (B)(6) 2011, PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE HAS NOT BEEN DISPATCHED FOR THIS EVENT TO DATE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR TWO (2) PATIENT'S SAMPLES THAT WERE GENERATED BY THE UNICEL DXC 600I ACCESS IMMUNOASSAY SYSTEM. REPEAT ANALYSIS OF THE SAMPLES ON THE SAME INSTRUMENT AND A DIFFERENT METHOD PRODUCED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE THAT FIT THE CLINICAL PICTURE OF THE PATIENTS. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. 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