BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1933561 · Received December 20, 2010

    Report

    Report Number
    2122870-2010-00909
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 21, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CENTRIFUGES SAMPLES FOR FOUR MINUTES AT 4,500 RPM. THE SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DAY OF THE EVENT AND AFTER THE EVENT. HOWEVER, ON (B)(6) 2010 ACCUTNI QC WAS INTERMITTENTLY FAILING WITH QNS (QUANTITY NOT SUFFICIENT) FLAGS. ROUTINE SYSTEM CHECKS WERE PERFORMED ON (B)(6) 2010 AND (B)(6) 2010 AND BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE WAS DISPATCHED: THE FSE STATED THAT THE NUT WHERE THE TUBING CONNECTS TO THE TRANSDUCER WAS RUSTY SO HE DECIDED TO REPLACE THE WHOLE ASSEMBLY. THE FSE IS NOT CERTAIN, HOWEVER, THAT THE PART WAS THE ROOT CAUSE OF HIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT, ABOVE THE AMI CUT OFF, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON THIS INSTRUMENT AND ON AN ALTERNATE METHODOLOGY PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. 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® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR