BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

    MDR report key: 2082449 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01339
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE DRAWN IN-HOUSE USING 5 ML LIHEP PLASMA TUBES. THE TUBES WERE FULL DRAWS. QC ON THE DAY OF THE EVENT PERFORMED OUTSIDE OF THE CUSTOMER'S ESTABLISHED RANGES DURING THE THIRD SHIFT. THE QC FAILURE PROMPTED THE OPERATOR TO REPEAT ALL CRITICAL ACCUTNI TESTS THAT HAD BEEN RAN ON THE THIRD SHIFT. THE CUSTOMER DID NOT REPORT ANY ISSUES WITH OTHER ASSAYS AT THE TIME OF CONTACT. SYSTEM CHECK DATA SUPPLIED BY THE CUSTOMER FROM (B)(6) 2011 FAILED TO MEET INSTRUMENT SPECIFICATIONS. THE CUSTOMER DID REPEAT THE FAILING PORTION OF THE SYSTEM CHECK AND OBTAINED PASSING RESULTS, HOWEVER, A FULL SYSTEM CHECK RUN WAS NOT REPEATED. A BCI FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO PRIME THE FLUIDICS SYSTEM OF THE CUSTOMER INSTRUMENT AND AIR BUBBLES WERE OBSERVED IN THE WASH PUMP. THE FSE REPLACED THE SEALS, BELT, ROTOR, AND O-RING ON THE WASH PUMP, AS WELL AS THE SEALS AND BELT ON THE PRECISION PUMP. THE FSE VERIFIED INSTRUMENT HARDWARE BY PERFORMING A SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED QC WITHIN THE CUSTOMER'S ESTABLISHED RANGES AFTER SERVICE WAS COMPLETED. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED BY THE FSE AT THE TIME OF SERVICE, 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 ERRONEOUS ELEVATED ACCUTNI RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF FOR TWO PATIENTS GENERATED BY ACCESS 2I (LXI) IMMUNOASSAY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON THE SAME UNIT AND ALTERNATE UNIT. LOWER RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT AND RESULT WITHIN THE NORMAL REFERENCE RANGE FOR THE SECOND PATIENT 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 ACCESS 2I (LXI) IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS2 LXI N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR