BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® ACCUTNI?

    MDR report key: 3241806 · Received July 22, 2013

    Report

    Report Number
    2122870-2013-00628
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K021814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS ACCUTNI DEVICE WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. THERE WAS NO EVIDENCE OF ANY SYSTEM ISSUES. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION RANGE, FOR ONE PATIENT, INVOLVING THE ACCESS ACCUTNI ASSAY USED IN CONJUNCTION WITH THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. AN INITIAL RESULT OF 0.071 NG/ML WAS OBTAINED. SUBSEQUENT TESTING OF THE SAME PATIENT¿S SAMPLE, CENTRIFUGED ALIQUOT, PRODUCED LOWER RESULTS OF 0.022 NG/ML AND 0.019 NG/ML, RESPECTIVELY, WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THE RESULT OF 0.022 NG/ML TO THE HOSPITAL. ALL SYSTEM PARAMETERS (QUALITY CONTROL (QC), CALIBRATIONS AND SYSTEM CHECK) WERE PERFORMING WITHIN THE SPECIFICATIONS. THE PATIENT¿S SAMPLE WAS COLLECTED IN 13X100 ML GREINER LITHIUM HEPARIN PLASMA TUBE AND CENTRIFUGED AT 4,800G (RELATIVE CENTRIFUGAL FORCE) FOR 4 MINUTES AT 20ºC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341775 ACCESS® ACCUTNI? IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER NA 231032

    Patients

    Seq Age Sex Outcome Treatment
    1